At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 36 enrolled

Drug / intervention

HPV 16 E7:12-20 +2 morebiological

Likely dose

gp100:209-217(210M) vaccine given subcutaneously; HPV 16 E7:12-20 given subcutaneouslyAI-extracted

Key inclusion· 6

✓Histologically confirmed primary melanoma with Breslow thickness 1.0-4.0 mm, or >4.0 mm with positive or negative regional lymph nodes
✓Must be HLA-A2.1 positive by serologic techniques, flow cytometry, or molecular techniques
✓Karnofsky performance status 80-100, ambulatory with good performance status
✓Enrollment prior to sentinel lymph node dissection (except those with previous lymph node dissection after initial 26 patient accrual)

Key exclusion· 4

✕Clinically detectable distant metastases
✕Require or likely to require systemic corticosteroids for intercurrent illness
✕Significant medical disease other than malignancy (e.g. COPD, ascites, pleural effusions) that would significantly increase risk of immunotherapy
✕History of other cancers or high risk for recurrence

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

Search/NCT00003895

NCT00003895Phase 2Completed

Compare CT.gov

A Randomized Phase II Trial to Determine the Immune Response to a Mutated gp100 Melanoma Peptide (209-2M) Vaccine in HLA-A2 Positive Patients With a >1mm Melanoma on Initial Biopsy

National Cancer Institute (NCI)·interventional·Posted Jul 18, 2003·Updated Feb 20, 2017

In Brief

A Phase 2 clinical trial evaluating HPV 16 E7:12-20, gp100:209-217(210M), and 1 other intervention for Recurrent Melanoma and 8 related conditions. Completed, enrolled 36 participants across 1 site.

Detailed Summary

This randomized pilot phase II trial studies how well vaccine therapy works in treating human leukocyte antigen class 1 histocompatibility, A-2 (HLA-A2) positive patients with melanoma. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsRecurrent Melanoma, Stage IA Melanoma, Stage IB Melanoma, Stage IIA Melanoma, Stage IIB Melanoma, Stage IIC Melanoma, Stage IIIA Melanoma, Stage IIIB Melanoma, Stage IIIC Melanoma

CountriesUnited States

Collaborators--

Timeline

Phase 2CompletedFinished

19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartApr 1999

First PostedJul 2003

Primary CompletionSep 2013

TodayJul 2026

First PostedJul 18, 2003

Enrollment StartApr 1, 1999

Primary CompletionSep 1, 2013

TodayJul 2, 2026

Enrollment to primary: 14.4 yearsPosted 23.0 years ago

Interventions

HPV 16 E7:12-20biological

Given SC

gp100:209-217(210M)biological