CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 175 enrolled
Drug / intervention
incomplete Freund's adjuvant +4 morebiological
Likely dose
Not stated in record
Key inclusion· 7
  • ✓Histologically confirmed stage IV melanoma (cutaneous, mucosal, ocular, or unknown primary)
  • ✓Measurable disease by RECIST criteria
  • ✓Must have 2 extremities uninvolved with tumor
  • ✓At least 2 intact (undissected) axillary and/or inguinal lymph node basins
Key exclusion· 8
  • ✕More than 3 brain metastases
  • ✕Metastatic lesions greater than 2 cm
  • ✕Prior radiotherapy to measurable disease
  • ✕Prior vaccination with any of the study peptides

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

Search/NCT00071981
NCT00071981Phase 2Completed
CompareCT.gov

A Randomized Phase II Trial of Multi-Epitope Vaccination With Melanoma Peptides For Cytotoxic T Cells And Helper T Cells For Patients With Metastatic Melanoma

Eastern Cooperative Oncology Group·interventional·Posted Nov 6, 2003·Updated Jun 28, 2023

In Brief

A Phase 2 clinical trial evaluating incomplete Freund's adjuvant, melanoma helper peptide vaccine, and 3 other interventions for Melanoma (Skin). Completed, enrolled 175 participants across 65 sites.

Detailed Summary

RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells. PURPOSE: This randomized phase II trial is studying four different vaccines using melanoma peptides from cytotoxic T cells and helper T cells to see how well they work in treating patients with metastatic melanoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMelanoma (Skin)
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 6, 2003
Enrollment StartMay 9, 2005
Primary CompletionAug 1, 2011
Study CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 22.7 years ago

Interventions

incomplete Freund's adjuvantbiological

Given by injection

melanoma helper peptide vaccinebiological

Given by injection

multi-epitope melanoma peptide vaccinebiological

Given by injection

sargramostimbiological

Given by injection

tetanus peptide melanoma vaccinebiological

Given by injection