Why Should I Be a Guinea Pig?
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1 Why Should I Be a Guinea Pig? Jeffrey E. Lee, M.D. Section of Melanoma Surgery, Department of Surgical Oncology Medical Director, Ben Love/El Paso Corporation Melanoma and Skin Center
2 Melanoma patient #1 76 year old woman 2005: Primary melanoma of right foot 0.49 mm, Clark II, no vertical growth phase, no mitoses Significant residual primary tumor WLE, STSG, IOLM, inguinal SLNB Residual melanoma, 2.2 mm, Clark IV, satellitosis, margins free Sentinel node negative 5/2008: Develops several small (<1 cm) cutaneous and dermal nodules at and below the right knee Biopsy confirms in-transit metastatic melanoma Staging reveals no additional disease
3 Melanoma patient #1 Treatment options Surgical removal of nodules +/- adjuvant Rx On- or off-protocol systemic therapy On- or off-protocol injection therapy Limb perfusion/infusion 6/2008: Off-protocol limb infusion with melphalan 9/2008: Modest disease progression in the leg Consents to protocol-based PV-10 PV-10 = Rose bengal Chemical stain Also may treat skin diseases, cancers
4 Melanoma patient #1 All 19 lesions treated with PV-10 Largest 11 mm Reinjected 4 times over 4 months Complete response Remains NED
5 Melanoma patient #2 32 year old man 2003: Primary melanoma over right scapula 1.4 mm, Clark IV, non-ulcerated WLE, IOLM, SLNB: 1/1 sentinel node + Completion axillary LND: no additional disease Adjuvant high-dose interferon alpha PET-CT 12/2008 NED 5/2009: Cough, hemoptysis Chest X-ray, MRI, PET-CT L hilar mass with pericardial involvement R adrenal mass CT biopsy of chest: Metastatic melanoma
6 Melanoma patient #2 Molecular testing of lung met C-KIT mutation negative NRAS mutation negative BRAF mutation negative HLA A2-positive Treatment options Off-protocol systemic therapy Biochemotherapy High-dose IL-2 Protocol-based systemic therapy Adoptive immunotherapy with tumor-infiltrating lymphocytes
7 Melanoma patient #2 Consents to surgery for tumor harvest for TIL production 6/09: Minimally invasive right adrenalectomy; tumor sent for TIL Two cycles off-protocol biochemotherapy; progresses TIL grow well; enough for Rx by 8/09 Begins protocol-based TIL treatment Lymphodepletion Infuse 1 billion of his own TIL IL-2 Appears to be responding
8 What are clinical trials? Studies that help us make progress in cancer care Clinical trials are conducted by a team Doctors, clinical nurses, research nurses, pharmacists Patients Clinical trials include investigations of New drugs and treatments, including surgical treatments New ways of delivering standard treatments Evaluations of side effects of treatments and quality of life Phases of clinical trials Phase I: Safest dose, side effects, best route Phase II: Overall effectiveness, response rate Phase III: Comparison to standard treatment
9 How does MDA protect patients on clinical trials? Review of all protocols for clinical research through IRB Doctors, nurses, pharmacists, scientists Chaplains, social workers, attorneys Patients Each trial has unique eligibility requirements Clinical trials are not always the best option for all patients under all circumstances Participation is always voluntary and requires consent
10 What is the informed consent process? Trial plan described by team member Risks, benefits and alternatives Opportunity for questions Translators available A continuing process Participation is voluntary and can be stopped at any time
11 What questions should I ask before entering a trial? What are the risks of the trial? Can the probability of benefit be estimated? What alternative treatments are available? What is the experience with the treatment so far? How often will I need to come back? Can any part of treatment or testing be done at home? How much of the treatment will be free? How much will be covered by my insurance?
12 Reasons our melanoma patients may want to consider a clinical trial Allows access to the newest and most promising treatments Allows the patient to be an active participant in their care We still do not know for certain what the best treatments are for many patients in many situations Clinical trials are an organized way for a patient to try new treatments; we sometimes have to try more than one treatment to find the one that works Enrollment in a clinical trial will help future patients
13 Advances in melanoma pioneered by clinical research and clinical trials at M.D. Anderson Surgery for primary melanoma; sentinel lymph node biopsy Staging as a guide to treatment and follow-up Limb perfusion and infusion Role of radiation therapy Surgery for metastatic disease Biochemotherapy Adoptive immunotherapy Vaccine treatments Molecularly targeted therapies Melanoma genetics and blood markers Prevention strategies
14 How do I find information about clinical trials? Ask your doctor or care team Call askmdanderson toll-free at MDA-6789 Visit The Learning Center Go to and click on Clinical Trials Go to the NCI website and click on Clincal Trials
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