Safety and Efficacy of Combination HDI and Anti-CTLA4 for Recurrent Inoperable Stage III or Stage IV Melanoma
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|ClinicalTrials.gov Identifier: NCT00610857|
Recruitment Status : Completed
First Posted : February 8, 2008
Results First Posted : October 17, 2016
Last Update Posted : June 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Drug: Anti-CTLA4 monoclonal antibody and HDI||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (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|
|Study Start Date :||November 2006|
|Primary Completion Date :||January 2015|
|Study Completion Date :||January 2015|
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)
- Best Objective Response Rate (BORR) [ Time Frame: Up to 44 months ]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 ]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 ]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 ]Median overall survival is the (point) estimate of the time corresponding to 50% estimated probability of survival.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00610857
|United States, Pennsylvania|
|UPCI Hillman Cancer Center|
|Pittsburgh, Pennsylvania, United States, 15232|
|Principal Investigator:||Ahmad Tarhini, MD||University of Pittsburgh|