CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 37 enrolled
Drug / intervention
Anti-CTLA4 monoclonal antibody and HDIdrug
Likely dose
Anti-CTLA4 monoclonal antibody and HDI 15 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00610857
NCT00610857Phase 2Completed

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

Ahmad Tarhini·interventional·Posted Feb 8, 2008·Updated Jun 22, 2017

In Brief

A Phase 2 clinical trial evaluating Anti-CTLA4 monoclonal antibody and HDI for Melanoma. Completed, enrolled 37 participants across 1 site.

Detailed Summary

To determine the safety and efficacy of the combination of HDI and anti-CTLA-4 monoclonal antibody for patients with recurrent inoperable stage III or stage IV melanoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMelanoma
CountriesUnited States
CollaboratorsPfizer

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 8, 2008
Enrollment StartNov 1, 2006
Primary CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 8.2 yearsPosted 18.4 years ago

Interventions

Anti-CTLA4 monoclonal antibody and HDIdrug

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.