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

NCT ID: NCT00006113

Last Updated: 2014-05-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-06-30
• Study Completion Date: 2006-04-30

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.

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.

Conditions

Melanoma (Skin)

Study Design

• Primary Study Purpose: TREATMENT

Interventions

MART-1 antigen

Intervention Type: BIOLOGICAL

aldesleukin

Intervention Type: BIOLOGICAL

gp100 antigen

Intervention Type: BIOLOGICAL

recombinant CD40-ligand

Intervention Type: BIOLOGICAL

recombinant interferon gamma

Intervention Type: BIOLOGICAL

recombinant interleukin-4

Intervention Type: BIOLOGICAL

sargramostim

Intervention Type: BIOLOGICAL

therapeutic autologous dendritic cells

Intervention Type: BIOLOGICAL

therapeutic tumor infiltrating lymphocytes

Intervention Type: BIOLOGICAL

tyrosinase peptide

Intervention Type: BIOLOGICAL

Candida albicans skin test reagent

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey S. Weber, MD, PhD

Role: STUDY_CHAIR

University of Southern California

Locations

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, United States

Countries

United States

Other Identifiers

LAC-USC-10M991

Identifier Type: -

Identifier Source: secondary_id

NCI-G00-1837

Identifier Type: -

Identifier Source: secondary_id

NCI-T99-0102

Identifier Type: -

Identifier Source: secondary_id

CDR0000068125 (10M-99-1)

Identifier Type: -

Identifier Source: org_study_id