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| Overall Recruitment Status: Enrollment complete |
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| Official Title |
| A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy Versus High Dose Interferon a-2b for Resected High Risk Melanoma |
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| California - Northern |
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| Acronym |
NCT No. |
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NCT01274338 |
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| Study Type |
Phase |
| Clinical Trial |
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| Purpose |
| This randomized phase III trial studies ipilimumab to see how well it works compared to high-dose interferon alfa-2b in treating patients with high-risk stage III-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 than interferon alfa-2b in treating patients with melanoma. |
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| Detailed Description |
| PRIMARY OBJECTIVES:
I. To evaluate recurrence-free survival (RFS) between patients randomized to receive post-operative adjuvant ipilimumab given at either 10 mg/kg (high dose ipilimumab; HIP) or 3 mg/kg (low dose ipilimumab: LIP) versus those randomized to receive high-dose interferon alfa-2b (HDI) utilizing a hierarchical design assessing HIP versus HDI first and LIP versus HDI second (if the first comparison is significant).
II. To evaluate overall survival (OS) between patients randomized to receive post-operative adjuvant ipilimumab given at either 10 mg/kg (HIP) or 3 mg/kg (LIP) versus those randomized to receive HDI utilizing a hierarchical design assessing HIP versus HDI first and LIP versus HDI second (if the first comparison is significant).
SECONDARY OBJECTIVES:
I. To evaluate safety and tolerability of post-operative adjuvant ipilimumab therapy given at either 10 mg/kg (HIP) or 3 mg/kg (LIP).
II. Among patients enrolled by Clinical Community Oncology programs (CCOPs), to compare the global quality of life (QOL) between the ipilimumab arms versus HDI using Functional Assessment of Cancer Therapy (FACT)-General (G) form and to evaluate the effect of treatment-related side effects that may have an impact on the health-related domains of QOL using Functional Assessment of Chronic Illness Therapy (FACIT)-diarrhea (D) and FACT-biological response modifiers (BRM).
OUTLINE: Patients age >= 18 are randomized to Arms A, B, or C. Additional cohort of up to 45 patients aged 12-17 are randomized to Arms D, E, or F after adult accrual has completed on arms A, B and C. Arms D, E and F will follow the same treatment regimen as Arms A, B and C, respectively.
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- White blood cell (WBC) >= 3,000/uL
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Absolute neutrophil count (ANC) >= 1,500/uL
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Platelets >= 100 x 10^3/uL
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Serum creatinine =< 1.5 mg/dL
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Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN)
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Serum bilirubin =< 1.5 ULN, (except patients with Gilbert's syndrome, who must have a total bilirubin less than 3.0 mg/dL)
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- Patients who have an active infection requiring current treatment with parenteral antibiotics
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Patients who have other significant medical, surgical, or psychiatric conditions or require 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 (AEs), such as a condition associated with frequent diarrhea
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- patients with a baseline of frequent diarrhea (e.g. irritable bowel syndrome) are not eligible
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Patients who have a documented history of inflammatory bowel disease (including ulcerative colitis and Crohn's disease) or diverticulitis (history of diverticulosis is allowed)
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Patients who have had any infectious disease vaccination (e.g., standard influenza, H1N1 influenza, pneumococcal, meningococcal, or tetanus toxoid) within 4 weeks prior to randomization
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Patients who are prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness
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Angiogenesis Modulating Agents
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Neoplasms by Histologic Type
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Neoplasms, Germ Cell and Embryonal
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Central Nervous System Agents
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Cytotoxic T-lymphocyte antigen 4
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Physiological Effects of Drugs
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