CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 57 enrolled
Drug / intervention
Recombinant Interferon Alfa +1 morebiological
Likely dose
Bevacizumab IV and Interferon Alfa-2b SCAI-extracted
Key inclusion· 8
  • Histologically or cytologically confirmed cutaneous melanoma with clinical evidence of metastatic disease, unresectable regional lymphatic disease, or extensive in-transit recurrent disease
  • Measurable disease: at least 20 mm by conventional imaging or at least 10 mm by spiral CT
  • ECOG performance status 0-2 AND Karnofsky score 60-100%
  • Life expectancy more than 6 months
Key exclusion· 10
  • Known brain metastases
  • Ocular melanoma
  • Symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
  • Uncontrolled hypertension

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

Search/NCT00026221
NCT00026221Phase 2Completed

A Phase 2 Study of Bevacizumab and Interferon-Alpha-2b in Metastatic Malignant Melanoma

National Cancer Institute (NCI)·interventional·Posted Jan 27, 2003·Updated Mar 17, 2016

In Brief

A Phase 2 clinical trial evaluating Recombinant Interferon Alfa and Bevacizumab for Recurrent Melanoma and Stage IV Skin Melanoma. Completed, enrolled 57 participants across 2 sites.

Detailed Summary

This randomized phase II trial is studying giving bevacizumab together with interferon alpha to see how well it works compared to giving bevacizumab alone in treating patients with metastatic malignant melanoma. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Interferon alpha may interfere with the growth of the cancer cells and slow the growth of the tumor. Combining bevacizumab with interferon alpha may kill more tumor cells.

Study Details

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

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartNov 1, 2001
Primary CompletionNov 1, 2013
TodayJul 2, 2026
Enrollment to primary: 12 yearsPosted 23.4 years ago

Interventions

Recombinant Interferon Alfabiological

Given SC

Bevacizumabbiological

Given IV