Ipilimumab or High-Dose Interferon Alfa-2b in Treating Patients With High-Risk Stage III-IV Melanoma That Has Been Removed by Surgery

Status: Recruiting
Phase: Phase 3
Diagnosis: Cutaneous Skin Cancer
NCT ID: NCT01274338 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-275


This phase III clinical trial is studying ipilimumab or high-dose interferon alfa-2b in treating patients with high-risk stage III or stage IV melanoma that has been removed by surgery. Monoclonal antibodies, such as ipilimumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of melanoma and other cancers. It is not yet known whether ipilimumab is more effective then interferon alfa-2b in treating patients with melanoma


Conducting Institutions:
Dana-Farber Cancer Institute, Beth-Israel Deaconess Medical Center, Massachusetts General Hospital

Overall PI:
Frank Stephen Hodi, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
David McDermott, MD, Beth Israel Deaconess Medical Center
Donald Lawrence, MD, Massachusetts General Hospital

Dana-Farber Cancer Institute: Suzanne MacRae, 617-632-5906, smacrae@partners.org
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

DISEASE CHARACTERISTICS: - Diagnosis of melanoma of a cutaneous origin or unknown primary - No ocular melanoma or melanoma of mucosal origin - Stage IIIB, IIIC, or IV (M1a or M1b) disease - Patients with stage IV melanoma must have normal LDH and distant skin, subcutaneous, lymph node, or lung metastases - No other visceral metastases allowed - Disease that has been completely resected with negative margins on resected specimens within the past 12 weeks - Disease-free status documented by a complete physical examination and imaging studies within 4 weeks prior to randomization - Imaging studies must include a total body PET-CT scan (with or without brain) and brain MRI or CT (if MRI is contraindicated) (if PET-CT cannot be done, CT scan of neck, chest, abdomen, and pelvis should be done) - Patients rendered free of disease by non-surgical means not allowed - Disease recurrence after adequate surgical excision of original primary cutaneous melanoma allowed provided one of the following criteria are met: - Recurrence in a regional lymph node basin after a prior complete lymph node dissection - Relapsed disease must be completely surgically resected with free margins - Recurrence in the form of in-transit or satellite metastases or distant skin/subcutaneous, nodal, or lung metastases that are completely surgically resected with free margins - Recurrence in a regional lymph node basin - Relapsed disease must be completely surgically resected with free margins PATIENT CHARACTERISTICS: - ECOG performance status 0-1 - WBC ≥ 3,000/μL - ANC ≥ 1,500/μL - Platelet count ≥ 100,000/μL - Hemoglobin ≥ 10 g/dL - Serum creatinine ≤ 1.8 mg/dL - AST and ALT ≤ 2.5 times upper limit of normal (ULN) - Serum bilirubin < 2 times ULN (< 3 mg/dL in case of Gilbert syndrome) - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use adequate method of contraception throughout the study and for up to 26 weeks after the last dose of high-dose recombinant interferon alpha-2b (HDI) - No active infection requiring concurrent treatment with parenteral antibiotics - None of the following: - Other significant medical, surgical, or psychiatric conditions - Requirement for any medication or treatment that, in the opinion of the investigator, may interfere with compliance, make the administration of ipilimumab or HDI hazardous, or obscure the interpretation of adverse events, such as a condition associated with frequent diarrhea - No documented history of inflammatory bowel disease, including ulcerative colitis and Crohn disease, or diverticulitis - History of diverticulosis allowed - No autoimmune disorders or conditions of immunosuppression that require current ongoing treatment with systemic corticosteroids (or other systemic immunosuppressants), including oral steroids or continuous use of topical steroid creams or ointments or ophthalmologic steroids - History of occasional (but not continuous) use of steroid inhalers allowed - None of the following: - History of symptomatic autoimmune disease - Rheumatoid arthritis - Systemic progressive sclerosis (scleroderma) - Systemic lupus erythematosus - Sjögren syndrome - Autoimmune vasculitis (e.g., Wegener granulomatosis) - Motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis) - Other CNS autoimmune disease (e.g., poliomyelitis, multiple sclerosis) - Autoimmune hypothyroid disease or type 1 diabetes allowed provided replacement therapy is administered - Not incarcerated or compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness - No other current malignancies except any prior in situ cancer, lobular carcinoma of the breast in situ, cervical cancer in situ, atypical melanocytic hyperplasia or melanoma in situ, multiple primary melanomas, basal or squamous skin cancer, or other malignancies for which the patient has been disease free for > 5 years - No active or chronic infection with HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV) - Patients must have negative testing for HIV, HBV, and HCV within the past 4 weeks PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No prior adjuvant treatment (chemotherapy, biotherapy, or limb perfusion) after resection - At least 30 days since prior radiotherapy, including after surgical resection - No prior or concurrent anti-CTLA4 monoclonal antibodies, CTLA-4 inhibitor or agonist, CD137 agonist, or prior interferon-α - At least 4 weeks since prior aldesleukin (IL-2), anti-tumor vaccine, or chemotherapy given before randomization - No infectious disease vaccination (e.g., standard influenza, H1N1 influenza, pneumococcal, meningococcal, or tetanus toxoid) within the past 4 weeks - No concurrent systemic corticosteroids (or other systemic immunosuppressants), including oral steroids (i.e., prednisone, dexamethasone), continuous use of topical steroid creams or ointments, or ophthalmologic steroids - Occasional but not continuous use of steroid inhalers allowed - Systemic corticosteroids (or other systemic immunosuppressants), including oral steroids (i.e., prednisone, dexamethasone), continuous use of topical steroid creams or ointments, or ophthalmologic steroids within the past 2 weeks allowed provided, in judgment of the treating physician investigator, that the patient is not likely to require resumption of treatment with these classes of drugs during the study - Replacement doses of steroids for patients with adrenal insufficiency allowed - No concurrent chemotherapy or radiotherapy - No other concurrent anticancer or investigational agent
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