Vaccine Therapy in Treating Patients With Metastatic Melanoma

Baylor Health Care System

Status and phase: Unknown; Phase 1

Conditions: Melanoma (Skin)

Treatments: Biological: therapeutic autologous dendritic cells; Biological: filgrastim

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00017355

BAYUMC-000048

NCI-4170

CDR0000068680

Details and patient eligibility

About

RATIONALE: Vaccines made from a patient's white blood cells mixed with tumor antigens may make the body build an immune response to kill tumor cells.

PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma.

Full description

OBJECTIVES:

• Determine the safety and tolerability of antigen-pulsed dendritic cell vaccine in patients with metastatic melanoma.
• Determine the longevity of melanoma-specific immunity in patients treated with this regimen.
• Perform serial analysis of T-cell and B-cell function in patients treated with this regimen.

OUTLINE: Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily on days 1-6 or 1-7. Patients undergo apheresis on days 6 and 7 or 6-8 to obtain peripheral blood mononuclear cells (PBMC). PBMC are processed for CD34+ cell isolation. These autologous CD34+ hematopoietic progenitor cells are cultured to generate dendritic cells (DC). DC are then pulsed with endotoxin-free keyhole limpet hemocyanin and HLA-A2-01 restricted flu-matrix peptides derived from melanoma-associated tumor antigens (MART-1:27-35, gp100:209-217, and MAGE-3). Antigen-pulsed DC are incubated with interferon alfa to induce DC maturation.

Patients receive priming injections of antigen-pulsed DC vaccine SC once every 2 weeks for 8 weeks. Treatment repeats at 2, 3, 4, and 5 months after the last priming injection in the absence of unacceptable toxicity or disease progression.

Patients are followed at 2 and 4 weeks and then every 3 months for 1.5 years.

PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed metastatic melanoma
• HLA-A2-01 phenotype
• Measurable disease
• No active CNS or hepatic metastases

PATIENT CHARACTERISTICS:

Age:

• 21 and over

Performance status:

• Karnofsky 80-100%

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• See Disease Characteristics
• No viral hepatitis

Renal:

• Not specified

Cardiovascular:

• No prior venous thrombosis, angina pectoris, or congestive heart failure
• Lactate dehydrogenase less than 2 times normal

Pulmonary:

• No prior asthma

Immunologic:

• Intradermal skin test positivity to mumps, Candida, or streptokinase antigen
• No known sensitivity to E. coli drug preparations
• No prior allergy to influenza vaccine
• No active infection
• No prior autoimmune disease (e.g., lupus erythematosus, rheumatoid arthritis, or thyroiditis)

Other:

• HIV negative
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 8 weeks since prior interleukin-2
• At least 4 weeks since prior interferon alfa

Chemotherapy:

• At least 8 weeks since prior chemotherapy

Endocrine therapy:

• At least 2 weeks since prior corticosteroids
• No concurrent corticosteroids

Radiotherapy:

• Not specified

Surgery:

• Not specified

Other:

• No concurrent immunosuppressive agents
• At least 2 weeks since prior immunosuppressive agents