CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 22 enrolled
Drug / intervention
QS21 +4 morebiological
Likely dose
p946 or p946/tet-p emulsified in IFA with QS21 adjuvant (specific dose not stated)AI-extracted
Key inclusion· 6
  • ✓Histologically confirmed unresectable metastatic melanoma (AJCC stage III or IV) OR resected melanoma with high risk of recurrence or mortality (stage IIB and above)
  • ✓Age 18 to 79 years
  • ✓Life expectancy greater than 12 months
  • ✓Adequate hematopoietic function: ANC >1,000/mm³, platelets >100,000/mm³, hemoglobin >9 g/dL
Key exclusion· 7
  • ✕Currently receiving cytotoxic chemotherapy or received it within preceding 3 months
  • ✕Known or suspected allergies to any component of the treatment vaccine
  • ✕Unresectable tumor likely to cause symptoms requiring therapy anticipated within 3 months
  • ✕Receiving acute treatment for serious infection within 14 days

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

Search/NCT00003224
NCT00003224Phase 1Completed
CompareCT.gov

Phase I Protocol for the Evaluation of the Safety and Immunogenicity of Vaccination With a Synthetic Melanoma Peptide in Patients With High Risk Melanoma

University of Virginia·interventional·Posted Aug 25, 2004·Updated Nov 20, 2014

In Brief

A Phase 1 clinical trial evaluating QS21, IFA (incomplete Freund's adjuvant), and 3 other interventions for Melanoma (Skin). Completed, enrolled 22 participants across 1 site.

Detailed Summary

RATIONALE: Vaccines made from peptide 946 may make the body build an immune response to kill tumor cells. Combining these vaccines with proteins from the tetanus vaccine, and/or with either QS21 or Montanide ISA-51 may be an effective treatment for metastatic melanoma. PURPOSE: Randomized phase I trial to study the effectiveness of vaccines made from peptide 946 with or without tetanus peptide, QS21, or Montanide ISA-51 in treating patients with metastatic melanoma that cannot be surgically removed or with melanoma that is likely to recur.

Study Details

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

Timeline

Phase 1CompletedFinished
19961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 25, 2004
Enrollment StartFeb 1, 1996
Primary CompletionAug 1, 2000
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 21.9 years ago

Interventions

QS21biological

vaccine adjuvant

IFA (incomplete Freund's adjuvant)biological

Peptides emulsified in IFA.

p946biological

This a nonamer peptide YLEPGPVTA from Gp100, used as a melanoma vaccine antigen.

p946/tet-pbiological

This peptide is a longer version of p946 (gp100 \[280-288\]) sythesized colinearly with the tetanus helper peptide (Tet-p)

Tet-pbiological

modified form of the p2 peptide from tetanus toxoid, used as nonspecific epitope for helper T cells.