NCT00003665

Brief Summary

Randomized phase I trial to study the effectiveness of vaccine therapy in treating patients who have stage IV melanoma. Vaccines may make the body build an immune response to kill tumor cells.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 1999

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1999

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2002

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2002

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

February 9, 2004

Completed
Last Updated

February 28, 2013

Status Verified

February 1, 2013

Enrollment Period

3.5 years

First QC Date

November 1, 1999

Last Update Submit

February 27, 2013

Conditions

Melanoma (Skin)

Keywords

stage IV melanomarecurrent melanoma

Study Arms (3)

Arm I

EXPERIMENTAL

Patients receive 3 different doses of peptide pulsed DC vaccine IV, each divided into 3 different peptide pulsed pools administered over 30 minutes.

Biological: dendritic cell-MART-1 peptide vaccineBiological: gp100 antigenBiological: therapeutic tumor infiltrating lymphocytesBiological: tyrosinase peptide

Arm II

EXPERIMENTAL

Patients receive 3 different doses of peptide pulsed DC vaccine subcutaneously/intradermally to sites with no evidence of disease. At the lowest dose, patients receive 3 different peptide pulsed pools, each administered at a separate site. At the higher doses, patients receive 3 injections further subdivided into 6 and administered at 6 distinct sites.

Biological: dendritic cell-MART-1 peptide vaccineBiological: gp100 antigenBiological: therapeutic tumor infiltrating lymphocytesBiological: tyrosinase peptide

Arm III

EXPERIMENTAL

Patients receive peptide pulsed DC vaccine intranodally in groin or ancillary lymph nodes at the lower 2 doses of the 3 administered to arms I and II. At the lower dose, patients receive 3 different peptide pulsed pools, each administered into a different node. At the higher dose, patients receive 3 injections further subdivided into 6 and administered at 6 distinct sites.

Biological: dendritic cell-MART-1 peptide vaccineBiological: gp100 antigenBiological: therapeutic tumor infiltrating lymphocytesBiological: tyrosinase peptide

Interventions

dendritic cell-MART-1 peptide vaccineBIOLOGICAL
Arm IArm IIArm III
gp100 antigenBIOLOGICAL
Arm IArm IIArm III
therapeutic tumor infiltrating lymphocytesBIOLOGICAL
Arm IArm IIArm III
tyrosinase peptideBIOLOGICAL
Arm IArm IIArm III

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: -Histologically confirmed stage IV melanoma Must be MHC Class I HLA-A2.1 PATIENT CHARACTERISTICS: * Age: Over 18 * Performance status: ECOG 0-1 * Life expectancy: At least 2 months * Platelet count at least 100,000/mm3 * INR no greater than 1.5 mg/dL * No coagulopathies including thrombocytopenia * Partial thromboplastin time no greater than 50 seconds * No major cardiac illness * No major respiratory illness * No active systemic infection or other illness * No peripheral vascular disease * Not pregnant or nursing * Effective contraception required of all fertile patients during and for one month after completion of treatment PRIOR CONCURRENT THERAPY: * At least 30 days since prior immunotherapy * No concurrent immunotherapy * At least 30 days since prior chemotherapy * No concurrent chemotherapy * At least 30 days since prior radiotherapy * No concurrent radiotherapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, 19104-4283, United States

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Brian J. Czerniecki, MD, PhD

    Abramson Cancer Center at Penn Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

February 9, 2004

Study Start

April 1, 1999

Primary Completion

October 1, 2002

Study Completion

November 1, 2002

Last Updated

February 28, 2013

Record last verified: 2013-02

Locations

US(1)