We have no conflicts of interest to disclose We would like some if you have any ideas

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1 Grand Rapids Clinical Oncology Program: A National Cancer Institute CCOP Michigan Society of Health System Pharmacists We have no conflicts of interest to disclose We would like some if you have any ideas 1 Funded by a National Cancer Institute CCOP Grant since 1983 and the following Cell structure and signal integration Antibody technology Cancer & developmental cell biology Consortium Members Bronson Battle Creek Mercy Health Partners Munson Medical Center Saint Mary s Health Care Spectrum Health Spectrum Health Reed City Hospital Van Andel Research Institute Affiliate Member Mecosta County Medical Center Vivarium & transgenics program Computational biology Cancer immunodiagnostics Systems biology Integrin signaling & tumorigenesis Molecular microscopy, microarray, epidemiology Cancer genetics Transcriptional regulation Molecular oncology Translational medicine Chromosome replication Cell signaling & carcinogenesis Structural sciences 4

2 Bench Bedside basic science modern medicine 300,000 screened 11 human testing 1 - approved 8 10 years!! $1,600,000,000!

3 Find it 300,000 compounds Make it tablet, capsule, intravenous See if it s stable Try it in cells Try it in animals Toxicity (short term & long term) Activity Pick the starting dose Investigational New Drug Application (IND) 30 Day Clock Get IRB Approval Pick the starting dose Start at low doses Safety Dose limiting toxicity (DLT) Maximum Tolerated dose (MTD) USA Regulatory pathway = INDNDA Take patients tumor IND* NDA* Analyze tumor genes Create individualized therapy Discovery Preclinical Clinical Phase I Clinical Phase II Clinical Phase III Commercial pre-ind meeting with FDA *Content: technical data (CMC) nonclinical (animal) study data clinical plans and data pre-nda meeting with FDA

4 Drug development is hard and takes a long time Preclinical Years (2-5) 30 Months Target Selection Validation Drug Lead Identification Drug Lead Optimization Months Months 3-5 Years Clinical Phase 1 Phase 2 Phase 3 Research studies to find better ways to prevent, detect, or treat cancer Help find ways to improve cancer care QUESTIONS Months Preclinical Development Total time Yrs Cost ~ $1-2bn 15 Phase I Is it safe? Phase II does it work? Phase III how does it compare? Source: Kola and Landis (2004)- Nature Reviews/Drug Discovery

5 First time in man - How much? Animal toxicity What is the body doing to the drug? A absorption (do you get any?) D distribution (where does it go?) M metabolism (does anything happen to it?) E elimination (how does it get out?) What is the drug doing to the body? Safety (Adverse Events) Lots of Patients More Safety Efficacy compared to standard therapy Specific tumor; measurable disease Genetic sub-sets More Safety Multiple doses Long term effects Cumulative toxicity Efficacy of drug - Does it shrink tumors! Drug A standard treatment Drug B investigational (experimental) drug Randomize - Drug A or Drug B Possible results Outcome A > B A remains standard A = B Uncertain B > A B is new standard

6 Drugs A + B standard treatment Drug C investigational (experimental) drug Randomize A+B or A+B+C Possible results Outcome A+B > A+B+C A+B remains standard A +B =A+B+C Uncertain A+B+C > A+B A+B+C is new standard Drugs A + B standard treatment Drug C investigational (experimental) drug Randomize A+B+Placebo vs A+B+C This is called a blinded trial Almost never used for cancer! How do you measure? CT scans, X-rays, MRI s, etc When do you measure? Before you start new treatment Every 2-3 months during treatment Complete Response (CR) can t find disease Partial Response (PR) 30% decrease Progressive Disease (PD) 20% increase

7 Tumor = size of a pea Tumor cells = 10 9 (10 plus 9 zero s = 10,000,000,000) New Drug = 99% effective!!!!!!! So let s treat the patient How d we do? 10 7 tumor cells left!! (10 plus 7 zero s = 100,000,000) That s why we keep treating! The Institutional Review Board (IRB) Are there proper protections in place for the safety of the patient? Regulatory compliance Protocols Does the patient know what they are getting into/ Informed consent 100% - easy Sherri 50% - not so easy

8 Remembering that I ll be dead soon is the most important tool I ve ever encountered to help me make the big choices in life.remembering that you are going to die is the best way I know to avoid the trap of thinking you have something to lose. Steve Jobs Something just isn t right! GOG 157 Randomized phase lll trial of three versus six cycles of adjuvant carboplatin and paclitaxel in early stage epithelial ovarian carcinoma

9 What are they? Who is involved? How are cases presented? The Treatment Decision Communication to the patient Is the patient there? Does the patient interact with the board? 35 Remy and Sophie It is an approach to treatment planning The ultimate goal is to determine the best possible treatment options for each patient.

10 Surgical Oncology Medical Oncology Radiation Oncology Pathologist Radiologist Pharm.D Selection Format Clinical Trials/Research and tumor boards Research Genetics Dietician Residents The treatment decision

11 Tumor Boards vrs Multispecialty Clinics/Teams I am alive today by the grace of God and the fact that I participated in a clinical trial. March 19, 2007 Our 36 th Wedding Anniversary Clueless that anything was wrong!!!! Mechanism by which physicians who are referring patients to Spectrum Health can participate in the tumor boards Part of the treatment team Improves the quality of care in the region 44

12 March 26, 2007: Visit to Primary Care Doc -URI. April 4, 2007: Symptoms worsening. Additional testing and referral. April 11, 2007: Pharyngeal Mass, appears to be blocking esophagus-- cancer suspected, an MRI was ordered. I contacted my wife who was vacationing in North Carolina April 12, 2007 Surgeries scheduled for pm Advised to talk to family members today as once trach is installed you will not be able to speak Check with attorney on status of will, medical power of attorney Biopsy confirms cancer Next steps Do tracheostomy to establish airway Biopsy the tumor Install stomach tube for feeding 46 Diagnosis: Poorly differentiated invasive squamous cell carcinoma Stage 4 cancer in neck and surrounding lymph cells. Dr s comment There is an 80% chance you won t survive the next two months. Tumor is inoperable, only 3mm from spinal cord Mary s question. Well, what do you think? My answer It is what it is, now we deal with it and pray. 48

13 May 4 - Round 1 of Chemo On Day 4, Mary said You stopped clicking last night June 13 - ENT Exam: your tumor is essentially gone June 25 - Round 2 of treatment Chemo and Radiation Invitation to participate in Clinical trial SCRI HN 08: A Phase II trial of Neoadjuvant Chemotherapy Plus Bevacizumab Followed by Concurrent Chemotherapy with Bevacizumab/Erlontobid/Radiation Therapy in the Treatment of Locally Advanced Squamous Cell Carcinoma of the Head and neck Clinical Trials managed by GRCOP 50 52

14 September 17, Full body PET Scan too soon to be conclusive, positive test (cancer still present) is likely. Thursday September 20 Your PET Scan came back totally negative!!!. It is a miracle March 13, Appointment with Clinical Oncologist at Lack s Cancer Center We all had the pleasure of witnessing a miracle, We had new drugs that worked, radiation that worked, a patient with a great attitude, a loving family and a lot of prayers March 19, We celebrated our 37 th Wedding anniversary (2011 is our 40 th ) March 6, month follow-up CT Scan Results all negative Dime sized mole on chest in the area of the lower sternum PCP and Cancer Docs all say it s nothing Mary said get rid of it Dermatologist says it s probably nothing but we will do a biopsy anyway. Biopsy results report malignant melanoma. Come in to see us tomorrow for surgery! 54

15 Sam, James & Carrington (my youngest grandchildren) were both born after my expiration date Partial funding for this video from Communities as Partners in Cancer Clinical Trials ENACCT and CCPH National Cancer Institute CANCER ( ) The NCI clinical trial registry is the nation s most comprehensive resource on cancer clinical trials Website Features to note: About Clinical Trials Trial Search 10 Step Guide: How to find a Cancer Treatment Trial Clinical Trials Results For Patients and For Medical Providers 60

16 Grand Rapids Clinical Oncology Program or Questions? GRCOP is an NCI designated CCOP (Community Clinical Oncology Program) Right in our backyard WE HAVE Real Answers, Real Options, Real Miracles Right here in our community! Hope for the Future