CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 84 enrolled
Drug / intervention
Aldesleukin +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/NCT01258855
NCT01258855Phase 2Completed
CompareCT.gov

A Randomized Phase II Study of Sequential Biotherapy With Aflibercept and High Dose IL-2 Versus High Dose IL-2 Alone in Patients With Inoperable Stage III or Stage IV Melanoma: Efficacy and Biomarker Study

National Cancer Institute (NCI)·interventional·Posted Dec 13, 2010·Updated May 10, 2019

In Brief

A Phase 2 clinical trial evaluating Aldesleukin, Laboratory Biomarker Analysis, and 1 other intervention for Metastatic Melanoma and 6 related conditions. Completed, enrolled 84 participants across 21 sites.

Detailed Summary

This randomized phase II trial studies how well aldesleukin with or without ziv-aflibercept works in treating patients with stage III-IV melanoma that cannot be removed by surgery. Aldesleukin may stimulate the white blood cells to kill cancer. Ziv-aflibercept may stop the growth of melanoma by blocking blood flow to the tumor. It is not yet known whether aldesleukin is more effective with or without ziv-aflibercept in treating melanoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Melanoma, Recurrent Melanoma, Stage III Cutaneous Melanoma AJCC v7, Stage IIIA Cutaneous Melanoma AJCC v7, Stage IIIB Cutaneous Melanoma AJCC v7, Stage IIIC Cutaneous Melanoma AJCC v7, Stage IV Cutaneous Melanoma AJCC v6 and v7
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 13, 2010
Enrollment StartJan 18, 2011
Primary CompletionMar 29, 2018
TodayJul 2, 2026
Enrollment to primary: 7.2 yearsPosted 15.6 years ago

Interventions

Aldesleukinbiological

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Ziv-Afliberceptbiological

Given IV