Vaccine Therapy Followed by Biological Therapy in Treating Patients With Stage III or Stage IV Melanoma

Sponsor

University of Southern California (Other)

Overall Status

Terminated

CT.gov ID

NCT00006113

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Melanoma (Skin)	Biological: MART-1 antigen Biological: aldesleukin Biological: gp100 antigen Biological: recombinant CD40-ligand Biological: recombinant interferon gamma Biological: recombinant interleukin-4 Biological: sargramostim Biological: therapeutic autologous dendritic cells Biological: therapeutic tumor infiltrating lymphocytes Biological: tyrosinase peptide Radiation: Candida albicans skin test reagent	Phase 2

Detailed Description

OBJECTIVES:

Determine the clinical response rate and immune response in HLA-A2 positive patients with stage III or IV melanoma after receiving autologous dendritic cells pulsed with melanoma antigen peptides (MART-1:26-35, gp100:209-217, and tyrosinase:368-376) and treated ex vivo with CD40-ligand and interferon gamma, followed by interleukin-2 in vivo.
Determine the toxicities of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients undergo leukapheresis to harvest autologous dendritic cells (ADCs). Melanoma peptides (MART-1:26-35, gp100:209-217, and tyrosinase:368-376) are pulsed separately onto ADCs, which are also treated ex vivo with CD40-ligand, interferon gamma, interleukin-4, sargramostim (GM-CSF), and Candida albicans skin test reagent. Patients receive each melanoma peptide pulsed ADC vaccine separately via 3 successive 10 minute infusions on day 1. Patients then receive interleukin-2 subcutaneously every 12 hours on days 2-6. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 4 weeks, then every 3 months for 2 years, then every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study within 18-24 months.

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Primary Purpose:

Treatment

Official Title:

A Phase II Trial of a MART-1/gp100/Tyrosinase Peptide-Pulsed Dendritic Cell Vaccine Treated With CD40 Ligand/Gamma Interferon With Subcutaneous IL-2 for Patients With Metastatic Melanoma

Study Start Date :

Jun 1, 1999

Actual Primary Completion Date :

May 1, 2003

Actual Study Completion Date :

Apr 1, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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