CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 44 enrolled
Drug / intervention
HDIL-2 +1 moredrug
Likely dose
HDIL-2 720,000 IUfrom 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/NCT01266603
NCT01266603Phase 2Completed
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A Phase II Trial of High Dose Interleukin-2 (HDIL-2) With Recombinant MAGE-A3 Protein Combined With Adjuvant System AS15 (recMAGE-A3 + AS15) in Patients With Unresectable or Metastatic Melanoma

M.D. Anderson Cancer Center·interventional·Posted Dec 24, 2010·Updated Feb 19, 2020

In Brief

A Phase 2 clinical trial evaluating HDIL-2 and recMAGE-A3 + AS15 for Melanoma. Completed, enrolled 44 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to learn if high-dose interleukin-2 (HDIL-2), when given in combination with recMAGE-A3 + AS15 ASCI (Antigen-Specific Cancer Immunotherapeutic), can help to control unresectable or metastatic melanoma in patients whose tumor tissue has the MAGE-A3 protein. The safety of this drug combination will also be studied. Researchers will also use samples of the original tumor or metastatic tissue (for example, lymph nodes or liver or lung) that are collected during screening to study if response to the study drug is related to the genes in the tissue.

Study Details

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

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 24, 2010
Enrollment StartFeb 22, 2011
Primary CompletionNov 1, 2018
TodayJul 2, 2026
Enrollment to primary: 7.7 yearsPosted 15.5 years ago

Interventions

HDIL-2drug

720,000 IU/kg by vein over an approximate 15 minute period every eight hours, for a maximum of 14 doses per cycle.

recMAGE-A3 + AS15biological

300 μg plus 420 μg of CpG7909 (a part of the Adjuvant System AS15) by intermuscular injection within 24 hours from first dose of HDIL-2.