NCT00334776

Brief Summary

RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill melanoma cells. PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with metastatic melanoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2003

Geographic Reach
1 country

2 active sites

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

October 1, 2003

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 8, 2006

Completed
Last Updated

May 21, 2014

Status Verified

May 1, 2014

Enrollment Period

1.7 years

First QC Date

June 7, 2006

Last Update Submit

May 19, 2014

Conditions

Intraocular MelanomaMelanoma (Skin)

Keywords

recurrent melanomastage IV melanomaciliary body and choroid melanoma, medium/large sizeiris melanomarecurrent intraocular melanomaextraocular extension melanoma

Outcome Measures

Primary Outcomes (4)

  • Overall survival

  • Progression-free survival

  • Time to progression

  • Toxicity

Interventions

MART-1 antigenBIOLOGICAL
gp100:209-217(210M) peptide vaccineBIOLOGICAL
therapeutic autologous dendritic cellsBIOLOGICAL
tyrosinase peptideBIOLOGICAL

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of melanoma * Metastatic disease * The following melanoma subtypes are eligible: * Unresectable, stage III-IV uveal melanoma * Metastatic mucosal melanoma * Measurable disease after attempted curative surgical therapy * Tumor tissue must be available for immunohistochemical staining * Positive for ≥ 1 of the following peptides: * MART-1: 26-35 (27L) * gp100: 209-217 (210M) * Tyrosinase: 368-376 (370D) * HLA-A \*0201 positive by DNA polymerase chain reaction assay PATIENT CHARACTERISTICS: * ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100% * Creatinine ≤ 2.0 mg/dL * Bilirubin ≤ 2.0 mg/dL * WBC ≥ 3,000/mm\^3 * Platelet count ≥ 75,000/mm\^3 * Hemoglobin ≥ 9.0 g/dL * No major systemic infections * No coagulation disorders * No major medical illness of the cardiovascular or respiratory system * No myocardial infarction within the past 6 months * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No known HIV positivity * No know positivity for hepatitis B surface antigen or hepatitis C antibody * No prior uveitis or autoimmune inflammatory eye disease * No other prior malignancy except cervical carcinoma in situ or basal cell skin cancer unless patient was curatively treated \> 5 years ago and has no detectable disease PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No more than 1 prior cytotoxic chemotherapy agent or regimen * Prior biologic or antiangiogenic therapies allowed * More than 1 month since prior and no concurrent radiotherapy, chemotherapy, adjuvant therapy, or any other therapy for melanoma * No prior MART-1: 26-35 (27L), gp100: 209-217 (210M), or tyrosinase: 368-376 (370D) peptides * No concurrent steroid therapy

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

Sponsors & Collaborators

Study Sites (2)

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90089-9181, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0942, United States

Location

MeSH Terms

Conditions

Uveal MelanomaMelanoma

Interventions

MART-1 AntigenProtein Subunit Vaccines

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasUveal NeoplasmsEye NeoplasmsNeoplasms by SiteEye DiseasesUveal DiseasesSkin NeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Melanoma-Specific AntigensNeoplasm ProteinsProteinsAmino Acids, Peptides, and ProteinsAntigens, NeoplasmAntigensBiological FactorsVaccines, AcellularVaccines, SubunitVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Jeffrey S. Weber, MD, PhD

    University of Southern California

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2006

First Posted

June 8, 2006

Study Start

October 1, 2003

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

May 21, 2014

Record last verified: 2014-05

Locations

US(2)