NCT00006113

Brief Summary

RATIONALE: Vaccines made from melanoma cells may make the body build an immune response to kill tumor cells. Biological therapies such as interferon gamma and interleukin-2 use different ways to stimulate the immune system and stop cancer cells from growing. Combining vaccine therapy with biological therapy may kill more tumor cells. PURPOSE: This phase II trial is studying giving vaccine therapy together with interferon gamma and interleukin-2 in treating patients with stage III or stage IV melanoma.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 1999

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

June 1, 1999

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2000

Completed
2.5 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2003

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

May 22, 2014

Status Verified

May 1, 2014

Enrollment Period

3.9 years

First QC Date

August 3, 2000

Last Update Submit

May 20, 2014

Conditions

Melanoma (Skin)

Keywords

stage III melanomastage IV melanomarecurrent melanoma

Interventions

MART-1 antigenBIOLOGICAL
aldesleukinBIOLOGICAL
gp100 antigenBIOLOGICAL
recombinant CD40-ligandBIOLOGICAL
recombinant interferon gammaBIOLOGICAL
recombinant interleukin-4BIOLOGICAL
sargramostimBIOLOGICAL
therapeutic autologous dendritic cellsBIOLOGICAL
therapeutic tumor infiltrating lymphocytesBIOLOGICAL
tyrosinase peptideBIOLOGICAL
Candida albicans skin test reagentRADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic melanoma * Measurable disease after attempted curative surgery * Unresectable stage III or IV uveal melanoma * Metastatic mucosal melanoma * HLA-A2.1 positive * No disease progression following high dose interleukin-2 (600,000 or 720,000 IU/kg every 8 hours) PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-1 Life expectancy: * Not specified Hematopoietic: * WBC at least 3,000/mm\^3 * Platelet count at least 75,000/mm\^3 * Hemoglobin at least 9.0 g/dL * No coagulation disorders Hepatic: * Bilirubin no greater than 2.0 mg/dL Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * No myocardial infarction within the past 6 months * Patients with documented or suspected coronary artery disease must undergo stress thallium test * No major cardiovascular illness Pulmonary: * No major pulmonary illness Immunologic: * HIV negative * Hepatitis B surface antigen negative * Hepatitis C antibody negative * No history of uveitis or autoimmune inflammatory eye disease Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No major systemic infection * No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or basal cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics * No prior MART-1:26-35, gp100:209-217, or tyrosinase:368-376 antigens Chemotherapy: * At least 1 month since prior chemotherapy for melanoma Endocrine therapy: * No concurrent steroid therapy Radiotherapy: * At least 1 month since prior radiotherapy for melanoma Surgery: * See Disease Characteristics Other: * At least 1 month since prior adjuvant therapy for melanoma * At least 1 month since other prior therapy for melanoma

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

Sponsors & Collaborators

Study Sites (1)

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90089, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

MART-1 AntigenaldesleukinCD40 LigandInterferon-gammaB-Cell Activating Factorsargramostim

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

Intervention Hierarchy (Ancestors)

Melanoma-Specific AntigensNeoplasm ProteinsProteinsAmino Acids, Peptides, and ProteinsAntigens, NeoplasmAntigensBiological FactorsMembrane GlycoproteinsGlycoproteinsGlycoconjugatesCarbohydratesTumor Necrosis FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesMembrane ProteinsInterferonsMacrophage-Activating FactorsLymphokines

Study Officials

  • Jeffrey S. Weber, MD, PhD

    University of Southern California

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2000

First Posted

January 27, 2003

Study Start

June 1, 1999

Primary Completion

May 1, 2003

Study Completion

April 1, 2006

Last Updated

May 22, 2014

Record last verified: 2014-05

Locations

US(1)