Bone Marrow Transplant Gynecologic Immunotherapy Phase 1. Breast Head & Neck Melanoma/Skin Sarcoma

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1 Karmanos offers clinical trials for many different forms of cancer. Below are the most current clinical trials open to new participants as of this publication's issue date. If you have any questions regarding these clinical trials, please contact JUNE 2013 Volume 2, Issue 4 To view the current issue online, please click here. Bone Marrow Transplant Gynecologic Immunotherapy Phase 1 Breast Head & Neck Melanoma/Skin Sarcoma Gastrointestinal Hematology Neuro-Oncology Thoracic Genitourinary Bone Marrow Clinical Trials BONE MARROW TRANSPLANT STUDY STUDY /II For more information on Bone Marrow Clinical Trials, contact the Karmanos Clinical Trials Office at To refer a patient for this clinical trial contact the Karmanos Patient Concierge at , newpt@karmanos.org or fill out this online referral form. Double-Blind, Randomized, Placebo-Controlled, Multicentre Clinical Study Followed By Open-Label Phase on the Efficacy and Tolerability of Budesonide 3 mg Effervescent Tablet in Patients with Resistant Oral Chronic GvHD. /II Study of Dasatinib in Recipients of Allogeneic Stem Cell Transplantation for Hematologic Malignancies STUDY BMTCTN0901 STUDY /II A Randomized, Multi-Center, Study of Allogeneic Stem Cell Transplantation Comparing Regimen Intensity in Patients with Myelodysplastic Syndrome or Acute Myeloid Leukemia. /II Study of Dasatinib in Recipients of Autologous Stem Cell Transplantation for Hematologic Malignancies

2 STUDY E2906 STUDY NA STUDY STUDY BMTCTN0702 IMMUNOTHERAPY STUDY ll Randomized Trial of Clofarabine as Induction and Post-Remission Therapy vs. Standard Daunorubicin & Cytarabine Induction and Intermediate Dose Cytarabine Post- Remission Therapy, Followed by Decitabine Maintenance vs. Observation in Newly- Diagnosed Acute Myeloid Leukemia in Older Adults (Age> or equal to 60 Years) A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs) for Transplantation in Pediatric and Adult Patients with Hematologic Malignancies and Other Indications Expanded Access of Prochymal (Ex-vivo Cultured Adult Human Mesenchymal Stem Cells) Infusion for the Treatment of Pediatric Patients who have Failed to Respond to Steroid Treatment for Acute GVHD A Trial of Single Autologous Transplant With or Without Consolidation Therapy Versus Tandem Autologous Transplant With Lenalidomide Maintenance for Patient with Multiple Myeloma. Treatment of Advanced Colorectal or Pancreatic Cancer with anti-cd3 x anti-erbitux Armed Activated T Cells (b) Breast Clinical Trials ADJUVANT STUDY B-47 STUDY STUDY B-49 For more information on Breast Clinical Trials, contact the Karmanos Clinical Trials Office at To refer a patient for this clinical trial contact the Karmanos Patient Concierge at , newpt@karmanos.org or fill out this online referral form. A Randomized Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of Docetaxel Plus Cyclophosphamide or Four Cycles of Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel) to Chemotherapy Plus Trastuzumab in Women with Node-Positive or High-Risk Node-Negative HER2-Low Invasive Breast Cancer Placebo-Controlled Trial of Lisinopril and Coreg CR to Reduce Cardiotoxicity in Patients with Breast Cancer Receiving (Neo)Adjuvant Chemotherapy with Trastuzumab (Herceptin ) A Clinical Trial Comparing the Combination of Docetaxel Plus Cyclophosphamide to Anthracycline-Based Chemotherapy Regimens for Women with Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer

3 ADJUVANT HORMONAL STUDY S1007 ADJUVANT RADIATION STUDY RTOG1005 NEOADJUVANT STUDY A, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer with Recurrence Score RS) of 25 or Less A Trial of Accelerated Whole Breast Irradiation with Hypofractionation plus Concurrent Boost versus Standard Whole Breast Irradiation plus Sequential Boost for Early-Stage Breast Cancer A Study of Anti-CD3 x Anti-HER2/neu (Her2Bi) Armed Activated T Cells (ATC) after Neoadjuvant Chemotherapy in Patients with HER2/neu (0-2+)- Negative Stage II-III Breast Cancers ADVANCED (Stage IV) CHEMOTHERAPY STUDY STUDY E3108 HORMONAL STUDY E3108 OTHERS STUDY E2108 A Study of anti-cd3 x anti-her2/neu Armed Activated T Cells for Patients with HER2/neu (0, 1+ or 2+) Metastatic Breast Cancer A Prospective Trial Correlating Progression Free Survival with CYP2D6 Activity in Patients with Metastatic Breast Cancer Treated with Single Agent Tamoxifen A Prospective Trial Correlating Progression Free Survival with CYP2D6 Activity in Patients with Metastatic Breast Cancer Treated with Single Agent Tamoxifen A Randomized Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer Gastrointestinal Clinical Trials For more information on Gastrointestinal Clinical Trials, contact the Karmanos Clinical Trials Office at To refer a patient for these clinical trials,

4 ESOPHAGUS METASTATIC STUDY S1201 GASTRIC AND GASTROESOPHAGEAL JUNCTION METASTATIC STUDY S1201 STUDY PANCREAS ADENOCARCINOMA (Metastatic) STUDY S1115 STUDY STUDY STUDY STUDY RTOG0848 contact the Karmanos Patient Concierge at , or fill out this online referral form. Randomized Pilot Study Prospectively Evaluating Treatment for Patients Based on ERCC1 (Excision Repair Cross- Complementing 1) for Advanced/Metastatic Esophageal, Gastric or Gastroesophageal Junction (GEJ) Cancer. Randomized Pilot Study Prospectively Evaluating Treatment for Patients Based on ERCC1 (Excision Repair Cross- Complementing 1) for Advanced/Metastatic Esophageal, Gastric or Gastroesophageal Junction (GEJ) Cancer. A Study of the Safety, Pharmacokinetics and Pharmacodynamics of Escalating Doses of the Selective Inhibitor of Nuclear Export (SINE) KPT-330 in Patients with Advanced or Metastatic Solid Tumor Malignancies Randomized Clinical Trial of AZD6244 Hydrogen Sulfate (NSC ) and MK-2206 (NSC ) VS MFOLFOX in Patients with Metastatic Pancreatic Cancer After Prior Chemotherapy A Randomized Placebo-Controlled Study of LY in Patients with Advanced or Metastatic Pancreatic Cancer Receiving Chemotherapy Percutaneous Cryoablation for the Palliation of Abdominal Pain Associated with Pancreatic Cancer Treatment of Advanced Colorectal or Pancreatic Cancer with anti-cd3 x anti- Erbitux Armed Activated T Cells(b) A Trial Evaluating Both Erlotinib and Chemoradiation as Adjuvant Treatment for Patients with Resected Head of Pancreas Adenocarcinoma HCC

5 STUDY COLON ADJUVANT STUDY C80702 STUDY S0820 METASTATIC (Includes Rectal) STUDY STUDY STUDY STUDY STUDY NEW A Clinical Trial of Intra]arterial TheraSphere in the Treatment of Patients with Unresectable Hepatocellular Carcinoma (HCC) A trial of 6 versus 12 Treatments of Adjuvant FOLFOX Plus CELECOXIB or PLACEBO for Patients with Resected Stage III Colon Cancer A Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers in Patients with Stage 0-III Colon Cancer, A Multicenter, Open-Label, Randomized, Phase 2 Study to Evaluate the Efficacy and Safety of NKTR-102 (PEG-Irinotecan) Versus Irinotecan in Patients with Second-Line, Irinotecan-Naïve, KRAS-Mutant, Colorectal Cancer with Metastatic or Locally Advanced Disease A Clinical Trial Evaluating TheraSphere in Patients with Metastatic Colorectal Carcinoma of the Liver who have Failed First Line Chemotherapy A, Multicenter, Open-Label, Randomized Study Evaluating the Efficacy and Safety of FOLFIRI + MEHD7945A versus FOLFIRI + Cetuximab in Second Line in Patients with KRAS Wild-Type Metastatic Colorectal Cancer Treatment of Advanced Colorectal or Pancreatic Cancer with anti-cd3 x anti- Erbitux Armed Activated T Cells (b) A Pivotal Study to Evaluate Overall Survival using MABp1 as a Monotherapy in Metastatic Colorectal Cancer Patients with Cachexia Genitourinary Clinical Trials RENAL STUDY For more information on Genitourinary Clinical Trials, contact the Karmanos Clinical Trials Office at To refer a patient for these clinical trials, contact the Karmanos Patient Concierge at , newpt@karmanos.org or fill out this online referral form. A, Open Label, Multi-center Study to Assess the Safety, Pharmacokinetics and

6 STUDY STUDY STUDY S0931 STUDY STUDY STUDY STUDY S1107 PROSTATE STUDY STUDY STUDY S1014 STUDY /II STUDY /II Effectiveness of AGS-16C3F Monotherapy in Subjects with Renal Cell Carcinoma of Clear Cell or Papillary Histology A Phase 1b, Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability of SGN-75 in Combination with Everolimus in Patients with CD70-Positive Metastatic Renal Cell Carcinoma A Randomized Study of Afinitor (RAD001, Everolimus) vs. Sutent (Sunitinib) in Patients with Metastatic Non Clear Cell Renal Cancer (ASPEN) EVEREST: EVErolimus for Renal Cancer Ensuing Surgical Therapy, A Study A Randomized, Double-blind Phase 2 Study Comparing Gemcitabine and Cisplatin in Combination with OGX-427 or Placebo in Patients with Advanced Transitional Cell Carcinoma A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pazopanib as Adjuvant Therapy for Subjects With Localized or Locally Advanced RCC Following Nephrectomy A Randomized, Open-Label, Phase 3 Study of BMS vs. Everolimus in Subjects with Advanced or Metastatic Clear-Cell Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy Parallel (Randomized) Evaluation of ARQ 197 and ARQ 197 in combination with Eriotinib in Papillary Renal Cell Carcinoma A Phase 3, Randomized, Double-blind, Controlled Trial of Cabozantinib (XL184) vs. Mitoxantrone Plus Prednisone in Men with Previously Treated Symptomatic Castration- Resistant Prostate Cancer Prostate Cancer: A Randomized Dose-Finding Study of the Effects of Two Doses of MPX Capsules on Rising Prostate-Specific Antigen Levels in Men Following Initial Therapy for Prostate Cancer Abiraterone Acetate Treatment for Prostate Cancer Patients with a PSA of More Than Four Following Initial Androgen Deprivation Therapy /II Trial to Establish the Safety and Preliminary Efficacy of the Combination of Docetaxel, Prednisone, and SOM 230 (Pasireotide) in Metastatic Castrate Resistant Prostate Cancer (CRPC) /IIa, Open Label, Dose Escalation and Safety Study of APC-100 in Men with Advanced Prostate Cancer

7 STUDY A, Open-Label Study of the Safety and Pharmacokinetics of Escalating Doses of DSTP3086S in Patients with Metastatic Castration-Resistant Prostate Cancer BLADDER STUDY /II A b/ii Trial of ALT-801 in Combination with Cisplatin and Gemcitabine in Muscle Invasive or Metastatic Urothelial Cancer STUDY A Study of Pazopanib in Combination with Weekly Paclitaxel in Refractory Urothelial Cancer Gynecologic Clinical Trials CERVIX STUDY GOG-0274 STUDY GOG-0263 OVARY STUDY GOG-0273 STUDY GOG-0268 STUDY ll STUDY GOG-0261 For more information on Gynecologic Clinical Trials, contact the Karmanos Clinical Trials Office at To refer a patient for these clinical trials, contact the Karmanos Patient Concierge at , newpt@karmanos.org or fill out this online referral form. A Trial of Adjuvant Chemotherapy Following Chemoradiation As Primary Treatment for Locally Advanced Cervical Cancer Compared to Chemoradiation Alone: The Outback Trial Randomized Clinical Trial of Adjuvant Radiation vs. Chemoradiation in Intermediate Risk, Stage I/IIA Cervical Cancer Treated with Initial Radical Hysterectomy and Pelvic Lymphadenectomy Chemotherapy Toxicity in Elderly Women with Ovarian, Primary Peritoneal or Fallopian Tube Cancer A Evaluation of Temsirolimus (CCI_779) (NCI SUPPLIED AGENT: NSC# ,IND# 61010) in Combination with Carboplatin and Paclitaxel Followed by Temsirolimus (CCI-779) Consolidation as First-Line Therapy in the Treatment of Stage III-IV Clear Cell Carcinoma of the Ovary A Randomized Double-Blind Phase 3 Trial Comparing EC145 and Pegylated Liposornal Doxorubicin (PLD/DOXIL/CAELYX) in Combination Versus PLD In Participants with Platinum-Resistant Ovarian Cancer A Randomized Trial of Paclitaxel Plus Carboplatin Versus Ifosfamide Plus Paclitaxel in Chemotherapy - Naïve Patients with Newly Diagnosed Stag I-IV Persistent or Recurrent Carinosarcoma (Mixed Mesodermal Tumors) of the Uterus

8 STUDY GOG0213 STUDY 2963 UTERUS STUDY GOG-0277 STUDY NEW STUDY GOG-0238 STUDY GOG-0261 A Randomized Controlled Clinical Trial of Carboplatin and Paclitaxel Alone or in Combination with Bevacizumab (NSC #704865, IND #7921) Followed by Bevacizumab and Secondary Cytoreductive Surgery in Platinum- Sensitive, Recurrent Ovarian, Peritoneal Primary and Fallopian Tube Cancer. NCI-Supplied Agents: (NSC #704865, IND #7921) A Rand Ph III Trial of Maintenance Chemo Comparing 12 Mthly Cycles of Single Agent Paclitaxel or Xyotax(CT-2103) (IND#70177), vs No Treatment Until Documented Relapse in Women w/ Adv Ovarian or Primary Peritoneal Ca Who Achieve a Complete Clinical Response to Primary Platinum/Taxane Chemo A Randomized Trial Of Gemcitabine (NSC# ) Plus Docetaxel (NSC# ) Followed By Doxorubicin (NSC# ) V. Observation For Uterus-Limited, High Grade Uterine Leiomyosarcoma A Randomized Phase 2 Non-Comparative Study of the Efficacy of PF AND PF in Recurrent Endometrial Cancer A Randomized Trial of Pelvic Irradiation with or without Concurrent Weekly Cisplatin in Patients with Pelvic-Only Recurrence of Carcinoma of the Uterine Corpus A Randomized Trial of Paclitaxel Plus Carboplatin Versus Ifosfamide Plus Paclitaxel in Chemotherapy - Naïve Patients with Newly Diagnosed Stag I-IV Persistent or Recurrent Carinosarcoma (Mixed Mesodermal Tumors) of the Uterus Head & Neck Clinical Trials STAGES I/II/III STUDY RTOG0920 For more information on Head & Neck Clinical Trials, contact the Karmanos Clinical Trials Office at To refer a patient for these clinical trials, contact the Karmanos Patient Concierge at , newpt@karmanos.org or fill out this online referral form. A Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab for Locally-Advanced Resected Head and Neck Cancer. STUDY An Open-label Phase 2 Study of ACE-041 in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

9 STUDY STAGES I - IV STUDY RTOG1016 A Randomized Trial of ARQ 197 (Tivantinib)/Cetuximab versus Cetuximab in Patients with Recurrent/Metastatic Head and Neck Cancer Trial of Radiotherapy Plus Cetuximab versus Chemoradiotherapy in HPV- Associated Oropharynx Cancer Hematology Clinical Trials MULTIPLE MYELOMA STUDY S1211 /II STUDY STUDY /II STUDY STUDY STUDY STUDY /II STUDY For more information on Hematology Clinical Trials, contact the Karmanos Clinical Trials Office at To refer a patient for these clinical trials, contact the Karmanos Patient Concierge at , newpt@karmanos.org or fill out this online referral form. A Randomized /II Study of Optimal Induction Therapy of Bortezomib, Dexamethasone and Lenalidomide with or without Elotuzumab (NSC ) for Newly Diagnosed High Risk Multiple Myeloma (HRMM) A study of Ganetespib +/- Bortezomib in Patients with Relapsed and/or Refractory Multiple Myeloma A Phase 1/2 Study of Array 520 in Patients with Relapsedor Refractory Multiple Myeloma A Phase 1b Study of Elotuzumab in Combination with Lenalidomide and Dexamethasone in Subjects with Multiple Myeloma and Normal Renal Function, Severe Renal Impairment, or End Stage Renal Disease Requiring Dialysis A Phase 1 Study of ARRY-520 and Bortezomib Plus Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma A Randomized Study Comparing Conventional Dose Treatment Using a Combination of Lenalidomide, Bortezomib and Dexamethasone (RVD) to High-Dose Treatment with Peripheral Stem Cell Transplant in the Initial Management of Myeloma in Patients up to 65 Years of Age Multicenter, Open-label, Single-arm, Phase 1b/2 Study of the Safety and Efficacy of Combination Treatment with Pomalidomide, Dexamethasone, and Carfilzomib (PdC) in Subjects with Relapsed and Relapsed/Refractory Multiple Myeloma Study of the Combination of Bendamustine and Dexamethasone in Patients

10 STUDY NEW /II AMYLOIDOSIS OR LIGHT CHAIN DEPOSITION DISEASE STUDY STUDY LEUKEMIA ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) STUDY STUDY S0805 STUDY STUDY ACUTE MYELOID LEUKEMIA (AML) STUDY with Relapsed AL Amyloidosis Phase 1b/2, Multicenter, Open-label Study of Oprozomib and Dexamethasone in Patients with Relapsed and/or Refractory Multiple Myeloma A Phase 3, Randomized, Controlled, Open-Label, Multicenter, Safety and Efficacy Study of Dexamethasone Plus MLN9708 or Physicians Choice of Treatment Administered to Patients With Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis Study of Pomalidomide, Bortezomib, and Dexamethasone (PVD) as First- Line Treatment of AL Amyloidosis or Light Chain Deposition Disease An Open-label, Randomized Phase 3 Study of Inotuzumab Ozogamicin Compared to a Defined Investigator's Choice in Adult Patients with Relapsed or Refractory CD22- Positive Acute Lymphoblastic Leukemia Study of Combination of Hyper-CVAD And Dasatinib (NSC ) with or without Allogeneic Stem Cell Translant in Patients with Philadelphia(Ph) Chromosome Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia (ALL) (A BMT STUDY) A Phase 3, Multicenter, Randomized Study To Evaluate The Substitution of Marqibo (Vincristine Sulfate Liposomes Injection, VSLI) for Standard Vincistrine Sulfate Injection (VSI) in the Induction, Intensification, and Maintenance Phases of Combination Chemotherapy in the Treatment of Malignant Hematology Leukemia Subjects > or = 60 Years old with Newly Diagnosed Acute Lymphoblastic Leukemia (ALL) An Open-Label, Phase 1/2 Study Of Inotuzumab Ozogamicin in Subjects with Relapsed or Refractory CD22-Positive Acute Lymphocytic Leukemia A Phase 1B Study to Evaluate the Safety and Preliminary Efficacy of PF , an

11 STUDY S1203 ACUTE PROMYELOCYTIC LEUKEMIA (APL) STUDY S0535 CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) STUDY STUDY S1117 LYMPHOMA HODGKIN'S STUDY STUDY NON-HODGKIN'S AGRESSIVE (MANTLE CELL, LARGE B-CELL LYMPHOMA) STUDY E1411 Oral Hedgehog Inhibitor, in Combination with Intensive Chemotherapy, Low dose ARA-C or Decitabine in Patients with Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome. A Randomized Study of Standard Cytarabine plus Daunorubicin (7+3) Therapy or Idarubicin with High Dose Cytarabine (IA)versus IA with Vorinostat (IA+V) in Younger Patients with Previously Untreated Acute Myeloid Leukemia (AML) A Study of ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin in Patients with Previously Untreated High Risk Acute Promyelocytic Leukemia Randomized, Double-blind, Placebo-controlled Phase 3 Study of Ibrutinib, a Bruton's Tyrosine Kinase (BTK) Inhibitor, in Combination with Bendamustine and Rituximab (BR) in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma A Randomized Study of Azacitidine in Combination with Lenalidomide (NSC ) vs. Azacitidine Alone vs. Azacitidine in Combination with Vorinostat (NSC ) for Higher-Risk Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML) An Open-Label Clinical Pharmacology Study of Brentuximab Vedotin (SGN-35) in Patients with CD30-Positive Hematologic Malignancies: CYP3A4 Drug-Drug Interactions, Excretion, and Special Populations A Randomized, Open-label, Phase 3 Trial of A+AVD Versus ABVD as Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma Intergroup Randomized Four Arm Study In Patients >= 60 With Previously Untreated Mantle Cell Lymphoma Of Therapy With: Arm A =Rituximab+ Bendamustine Followed By Rituximab Consolidation (RB -R); Arm B = Rituximab + Bendamustine + Bortezomib Followed By Rituximab Consolidation (RBV -R), Arm C = Rituximab + Bendamustine Followed By Lenalidomide + Rituximab Consolidation

12 (RB - LR) or Arm D = Rituximab + Bendamustine + Bortezomib Followed By Lenalidomide + Rituximab Consolidation (RBV - LR) STUDY STUDY S1106 STUDY STUDY INDOLENT STUDY NEW T CELL STUDY STUDY MYELODYSPLASTIC SYNDROME (MDS) STUDY STUDY S1117 An Open-label, Multicenter, Single-arm, Phase 2 Study of Ibrutinib (PCI-32765) in Subjects with Refractory Follicular Lymphoma A Randomized Trial of R-HCVAD/MTX/Ara-C Induction Followed by Consolidation with an Autologous Stem Cell Transplant vs. RBendamustine Induction Followed by Consolidation with an Autologous Stem Cell Transplant for Patients< or= 65 Years of Age with Previously Untreated Mantle Cell Lymphoma An Open-Label Clinical Pharmacology Study of Brentuximab Vedotin (SGN-35) in Patients with CD30-Positive Hematologic Malignancies: CYP3A4 Drug-Drug Interactions, Excretion, and Special Populations An Open-Label, Randomized, Phase 2 Study to Assess the Effectiveness of RCHOP With or Without VELCADE in Previously Untreated Patients with Non- Germinal Center B-Cell-like Diffuse Large B-Cell Lymphoma A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-1101 (CAL-101) in Combination with Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas A Phase 3, Randomized, Two-Arm, Open-Label, Multicenter, International Trial of Alisertib (MLN8237) or Investigator's Choice (Selected Single Agent) in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma An Open-Label Clinical Pharmacology Study of Brentuximab Vedotin (SGN-35) in Patients with CD30-Positive Hematologic Malignancies: CYP3A4 Drug-Drug Interactions, Excretion, and Special Populations A Phase 1B Study to Evaluate the Safety and Preliminary Efficacy of PF , an Oral Hedgehog Inhibitor, in Combination with Intensive Chemotherapy, Low dose ARA-C or Decitabine in Patients with Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome A Randomized Study of Azacitidine in Combination with Lenalidomide (NSC ) vs. Azacitidine Alone vs. Azacitidine in Combination with Vorinostat (NSC ) for Higher-Risk Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML)

13 Immunotherapy Clinical Trials For more information on Immunotherapy Clinical Trials, contact the Karmanos Clinical Trials Office at To refer a patient for these clinical trials, contact the Karmanos Patient Concierge at , newpt@karmanos.org or fill out this online referral form. STUDY STUDY STUDY For study descriptions and eligibility requirements on these trials please visit the Karmanos website. A Study of anti-cd3 x anti-her2/neu Armed Activated T Cells for Patients with HER2/neu (0, 1+ or 2+) Metastatic Breast Cancers. A Study of Anti-CD3 x Anti-HER2/neu (Her2Bi) Armed Activated T Cells (ATC) after Neoadjuvant Chemotherapy in Patients with HER2/neu (0-2+)-Negative Stage II-III Breast Cancers Treatment of Advanced Colorectal or Pancreatic Cancer with anti-cd3 x anti- Erbitux Armed Activated T Cells (b) ï» Melanoma/Skin Clinical Trials ADJUVANT STUDY E1609 STUDY ADVANCED STUDY E2607 STUDY For more information on Melanoma/Skin Clinical Trials, contact the Karmanos Clinical Trials Office at To refer a patient for these clinical trials, contact the Karmanos Patient Concierge at , newpt@karmanos.org or fill out this online referral form. A Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy Versus High-Dose Interferon a-2b for Resected High-Risk Melanoma A, Randomized, Double-Blind, Placebo-Controlled Study of Vemurafenib (RO ) Adjuvant Therapy in Patients with Surgically Resected, Cutaneous BRAF- Mutant Melanoma at Hih Risk for Recurrence A Trial of Dasatinib in KIT-Positive Patients with Unresectable Locally Advanced or Stage IV Mucosal, Acral and Vulvovaginal Melanomas A b, Open-Label, Dose-Escalation Study Evaluating the Safety, Tolerability and Pharmacokinetics of Vemurafenib in Combination with GDC-0973 when Administered in BRAFV600E-Mutation Positive Patients, Previously Treated (but without Prior Exposure to BRAF or MEK Inibitor Therapy) or Previously Untreated for Locally- Advanced/Unresectable or Metastatic Melanoma or Those Who Have Progressed after

14 Treatment with Vemurafenib STUDY NA STUDY STUDY A Multi-Center Study of High Dose Aldesleukin (Interleukin-2) + Vemurafenib Therapy in Patients with BRAFV600 Mutation Positive Metastatic Melanoma A Randomized, Open-Label Phase 3 Trial of BMS versus Investigator's Choice in Advanced (Unresectable or Metastatic Melanoma Patients Progressing Post Anti-CTLA- 4 Therapy A Single Arm Open-Label Study of Vemurafenib Followed by a Continuous Administration of Ipilimumab in Subjects with Previously Untreated V600 BRAF Mutated Advanced Melanoma Neuro-Oncology Clinical Trials There are currently no open clinical trials. For more information on Karmanos Clincial Trials please contact the Karmanos Clinical Trials Office at Clinical Trials The Karmanos Phase 1 Program is one of 14 National Cancer Institute funded Phase 1 Clinical Pharmacology Programs in North America. In hope of finding new and better ways to help cancer patients, Karmanos Phase 1 Program has many clinical trials underway. Due to the specific requirements for patient eligibility, we are unable to post all of our open Phase 1 Clinical Trials in this newsletter. If you would like more information on our open Phase 1 Clinical Trials or to refer a patient, please contact Alima Patterson at or Tyrea Nash at or phase1@karmanos.org. All patients will need to go through an initial new patient screening consultation to determine if they are eligible for one of our Phase 1 studies and to ensure this is the best treatment option available for them. Sarcoma Clinical Trials There are currently no open clinical trials. For more information on Karmanos Clincial Trials please contact the Karmanos Clinical Trials Office at Thoracic Clinical Trials

15 LUNG ADJUVANT STUDY E1505 STAGE III A/B STUDY STUDY /II STAGE IV ALK STUDY EGFR STUDY STUDY S0819 STUDY RECURRENT EGFR STUDY /II STUDY For more information on Thoracic Clinical Trials, contact the Karmanos Clinical Trials Office at To refer a patient for these clinical trials, contact the Karmanos Patient Concierge at , newpt@karmanos.org or fill out this online referral form. A Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (> 4 cm) - IIIA Non-Small Cell Lung Cancer (NSCLC) LUX-Lung 8: A Randomized, Open-label Trial of Afatinib versus Erlotinib in Patients with Advanced Squamous Cell Carcinoma of the Lung as Second-line Therapy Following First-line Platinum-based Chemotherapy A /II Study of MGCD265 in Combination with Erlotinib or Docetaxel in Subjects With Advanced Malignancies and in Subjects with Advanced Non-Small Cell Lung Cancer (NSCLC) Phase 3, Randomized, Open-Label Study of the Efficacy and Safety of Crizotinib versus Pemetrexed/Cisplatin or Pemetrexed/Carboplatin in Previously Untreated Patients with Non-Squamous Carcinoma of the Lung Harboring A Translocation or Inversion Event Involving The Anaplastic Lymphoma Kinase (ALK) Gene Locus LUX-Lung EAP US; An Open Label Expanded Access Program of Afatinib (BIBW 2992) for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation(s) A Randomized, Study Comparing Carboplatin/Paclitaxel or Carboplatin/Paclitaxel/Bevacizumab with or without Concurrent Cetuximab in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) LUX-Lung 8: A Randomized, Open-label Trial of Afatinib versus Erlotinib in Patients with Advanced Squamous Cell Carcinoma of the Lung as Second-line Therapy Following First-line Platinum-based Chemotherapy A Phase 1/2, Open-Label, Safety, Pharmacokinetic and Preliminary Efficacy Study of Oral CO-1686 in Patients with Previously Treated Mutant EGFR Non-Small Cell Lung Cancer (NSCLC) A, Double-Blind, Placebo-Controlled, Randomized Study Evaluating the Safety

16 SCLC EXTENSIVE STUDY /II MESOTHELIOMA STUDY S0905 /II and Efficacy of Carboplatin/Paclitaxel and Carboplatin/Paclitaxel/Bevacizumab with and without GDC-0941 in Patients with Previously Untreated Advanced or Recurrent Non- Small Cell Lung Cancer A Phase 1/2 Study to Assess the Safety and Efficacy of Lorvotuzumab Mertansine (IMGN901) in Combination with Carboplatin/Etoposide in Patients with Advanced Solid Tumors including Extensive Stage Small Cell Lung Cancer A /Randomized Study of Cediranib (NSC #732208) versus Placebo in Combination with Cisplatin and Pemetrexed in Chemonaive Patients with Malignant Pleural Mesothelioma Karmanos Cancer Institute 4100 John R Detroit, Michigan KARMANOS ( ) karmanos.org To refer a patient or for more information on open clinical trials at the Karmanos Cancer Institute, call Karmanos ( ) To schedule an appointment, please call between 7:30 AM â 5:30 PM, Monday â Friday 2012 Karmanos Cancer Institute This was sent to lowed@karmanos.org. To ensure that you continue receiving our s, please add us to your address book or safe list. manage your preferences opt out using TrueRemove. Got this as a forward? Sign up to receive our future s.