Safety and Efficacy of Combination HDI and Anti-CTLA4 for Recurrent Inoperable Stage III or Stage IV Melanoma
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Safety and Efficacy of Combination Biotherapy With High-dose Interferon Alfa-2b and Anti-CTLA4 Monoclonal Antibody for Recurrent Inoperable Stage III or Stage IV Melanoma|
- Best Objective Response Rate (BORR) [ Time Frame: Up to 44 months ] [ Designated as safety issue: No ]Intention to treat response rate is estimated by the proportion of patients with a best response of CR, PR, or SD by Response Evaluation Criteria in Solid Tumors [RECIST] version 1.0
- Progression-free Survival (PFS) [ Time Frame: Up to 44 months ] [ Designated as safety issue: No ]Time from initial treatment date of to date of documented progression of disease progression (TTP)
- 1-year Overall Survival (OS) [ Time Frame: Time from initial treatment date, up to 1 year ] [ Designated as safety issue: No ]1-year survival is the estimated probability of surviving one year expressed as a percent (probability of survival is not probability of dying).
- Median Overall Survival (Point Estimate) [ Time Frame: Up to 44 months ] [ Designated as safety issue: No ]Median overall survival is the (point) estimate of the time corresponding to 50% estimated probability of survival.
|Study Start Date:||November 2006|
|Study Completion Date:||January 2015|
|Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Experimental: Anti-CTLA4 monoclonal antibody and HDI
Specific Aim #1: Test the hypothesis that the combination of IFNa-2b and anti-CTLA-4 monoclonal antibody will improve the response rate in patients with recurrent inoperable AJCC stage III and stage IV melanoma. Our therapeutic target is achieving, with acceptable toxicity, a 20% or better rate of objective response, CR or PR by RECIST criteria, as compared to the 5% to 10% expected in patients eligible for study. Study size is planned in terms of our primary efficacy endpoint, objective response.
Drug: Anti-CTLA4 monoclonal antibody and HDI
One course of therapy consists of three cycles (1 cycle=28days). Anti-CTLA4 monoclonal antibody (15 mg/kg i.v.) will be given during the first cycle only. HDI will be given all three cycles - cycle 1: 20 MU/m2 i.v. on days 0, 1, 2, 3, 4 a week (MTWRF) for 4 weeks; cycle 2: 10 MU/m2 s.c. 3 days a week (MWF) for 4 weeks; and cycle 3: 10 MU/m2 s.c. 3 days a week (MWF) for 4 weeks.
Response assessment will be carried out at day 56 and day 84. Every patient will receive 3 cycles regardless of response status after the first 2 cycles. However, a patient may be taken off therapy in the event of clinical progression at the discretion of the treating physician.
Patients without evidence for disease progression after 3 cycles may be offered additional cycles two weeks after completion of the third cycle. Therapy will continue for a maximum of 12 months.
Other Name: Anti-CTLA4 monoclonal antibody (CP-675,206)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00610857
|United States, Pennsylvania|
|UPCI Hillman Cancer Center|
|Pittsburgh, Pennsylvania, United States, 15232|
|Principal Investigator:||Ahmad Tarhini, MD||University of Pittsburgh|