Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma

National Cancer Institute (NCI)

Status and phase

Completed

Phase 2

Conditions

Melanoma (Skin)

Treatments

Biological: gp209-2M antigen

Biological: incomplete Freund's adjuvant

Biological: aldesleukin

Study type

Interventional

Funder types

NIH

Identifiers

NCT00019487

CDR0000066287

NCI-T98-0012

NCI-98-C-0095

Details and patient eligibility

About

RATIONALE: Vaccines made from a person's white blood cells may make the body build an immune response and kill tumor cells.

PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma that has not responded to previous therapy.

Full description

OBJECTIVES:

Determine whether reinfused activated cells alone or in conjunction with high or subcutaneous dose interleukin-2 may result in clinical tumor regression in patients with metastatic melanoma who had previously failed therapy on protocols involving immunization against the gp100 molecule.
Determine the survival of infused cells with antitumor activity in these patients.

OUTLINE: This is a salvage regimen.

Patients undergo leukopheresis to obtain peripheral blood mononuclear cells or tumor biopsy to obtain tumor infiltrating lymphocytes (TIL). Cells are incubated in the presence of gp209-2M peptide and then harvested and cloned. Patients receive 30-minute IV infusions of these in vitro sensitized cells. Treatment repeats every 2 weeks for 2 courses. An additional cohort of 8 patients receives gp209-2M peptide in Montanide ISA-51 subcutaneously in 2 different sites followed 2 days later by the adoptive transfer of cloned lymphocytes. At 4 to 6 weeks after the treatment courses, patients with stable or regressing disease may be retreated.

Patients with disease progression after 2 courses may receive 2 additional courses of cell infusion followed by interleukin-2 (IL-2) on one of two schedules. One cohort of patients receives IL-2 by intravenous bolus over 15 minutes every 8 hours beginning on the day after cell infusion and continuing for up to 5 days of each treatment course. Another cohort receives IL-2 by daily subcutaneous injections on days 1-12 of each course of therapy. If after 12-16 patients have been treated with cloned cells alone initially and responses are inadequate, subsequent patients entered into this study are randomized to receive the cell infusion followed by IL-2 on one of the two described schedules.

Patients are followed at 4-6 weeks.

PROJECTED ACCRUAL: A total of 91 patients will be accrued for this study over 2 years.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

Histologically proven metastatic melanoma that has failed therapy on protocols involving immunization against the gp100 molecule
Measurable or evaluable metastatic disease
Must be HLA-A201 positive by standard HLA typing

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

ECOG 0-2

Life expectancy:

Greater than 3 months

Hematopoietic:

Absolute neutrophil count greater than 1,000/mm^3
Platelet count greater than 100,000/mm^3
Hemoglobin greater than 8.0 g/dL

Hepatic:

Bilirubin no greater than 2.0 mg/dL
ALT/AST less than 4 times upper limit of normal

Renal:

Creatinine no greater than 1.6 mg/dL

Cardiovascular:

For patients randomized to receive interleukin-2:
- No major medical illnesses of the cardiovascular system

Pulmonary:

For patients randomized to receive interleukin-2:
- No major medical illnesses of the pulmonary system

Other:

HIV negative
Hepatitis B antigen negative
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
For patients randomized to receive interleukin-2:
- No active systemic infection
- No other major medical illnesses of immune system
- No coagulation disorders