Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

Vaccine Therapy in Treating Patients With Metastatic Melanoma

Lead Sponsor:

University of Southern California

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Intraocular Melanoma

Melanoma (Skin)

Eligibility:

All Genders

16+ years

Phase:

PHASE2

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 study...

Detailed Description

OBJECTIVES: Primary * Determine clinical response in HLA-A \*0201-positive patients with metastatic melanoma treated with an intradermally administered vaccine comprising autologous dendritic cells ...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    October 1 2003

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    June 1 2005

    Estimated Enrollment :

    6 Patients enrolled

    Trial Details

    Trial ID

    NCT00334776

    Start Date

    October 1 2003

    End Date

    June 1 2005

    Last Update

    May 21 2014

    Active Locations (2)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (2 locations)

    1

    USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, United States, 90089-9181

    2

    University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, United States, 48109-0942