CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 38 enrolled
Drug / intervention
recombinant interferon alfa-2b +2 morebiological
Likely dose
Not stated in 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/NCT01100528
NCT01100528Phase 2Completed

Adjuvant Therapy for Patients With Primary Uveal Melanoma With Genetic Imbalance

Case Comprehensive Cancer Center·interventional·Posted Apr 9, 2010·Updated Feb 26, 2019

In Brief

A Phase 2 clinical trial evaluating recombinant interferon alfa-2b, dacarbazine, and 1 other intervention for Ciliary Body and Choroid Melanoma, Medium/Large Size and 3 related conditions. Completed, enrolled 38 participants across 1 site.

Detailed Summary

RATIONALE: Drugs used in chemotherapy, such as dacarbazine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Recombinant interferon alfa-2b may interfere with the growth of tumor cells. Giving interferon alfa-2b together with dacarbazine may be an effective treatment for primary uveal melanoma. PURPOSE: This phase II trial is studying how well giving dacarbazine together with recombinant interferon alfa-2b works in treating patients with primary uveal melanoma with genetic imbalance.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 9, 2010
Enrollment StartNov 11, 2009
Primary CompletionJul 25, 2015
Study CompletionDec 14, 2017
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 16.2 years ago

Interventions

recombinant interferon alfa-2bbiological

Given subcutaneously (SC) 3 times a week for 24 weeks

dacarbazinedrug

Given IV on days 1 and 29

laboratory biomarker analysisother

Correlative studies obtained prior to therapy, every 8 weeks while on therapy, and then every 6 months during follow-up