Gene-Modified White Blood Cells Followed By Interleukin-2 and Vaccine Therapy in Treating Patients With Metastatic Melanoma

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Inserting a gene that has been created in the laboratory into a person's white blood cells may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Vaccines may make the body build an immune response to kill tumor cells. Combining gene-modified white blood cell infusions with interleukin-2 and vaccine therapy may kill more tumor cells.

PURPOSE: This phase I trial is studying how well giving gene-modified white blood cells when given together with interleukin-2 and vaccine therapy works in treating patients with metastatic melanoma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institutes of Health Clinical Center (CC)
• Collaborator: National Cancer Institute (NCI)
• Treatments: Aldesleukin; Cyclophosphamide; Fludarabine; Fludarabine phosphate; Vaccines

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of melanoma

• Metastatic disease

• Measurable disease

• Refractory to standard therapy, including high-dose interleukin-2 therapy

• HLA-A*0201 positive

• Progressive disease during prior immunization to melanoma antigens OR prior treatment with anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) cellular therapy with or without myeloablation allowed provided toxicity resolved to ≤ grade 2 (except vitiligo) AND patient does not require systemic steroids

• No brain metastases

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• More than 3 months

Hematopoietic

• Absolute neutrophil count > 1,000/mm^3

• Platelet count > 100,000/mm^3

• Hemoglobin > 8.0 g/dL

• Lymphocyte count > 500/mm^3

• WBC > 3,000/mm^3

• No coagulation disorders

Hepatic

• AST and ALT < 3 times upper limit of normal (ULN)

• Bilirubin ≤ 2.0 mg/dL (3.0 mg/dL in patients with Gilbert's syndrome)

• Hepatitis B surface antigen negative

• Hepatitis C antibody negative (unless antigen negative)

Renal

• Creatinine ≤ 1.6 mg/dL

Cardiovascular

• LVEF ≥ 45% by cardiac stress test

• No LVEF < 45% in patients ≥ 50 years of age

• No myocardial infarction

• No cardiac arrhythmias

• No symptomatic cardiac ischemia

• No prior EKG abnormalities

• No other major cardiovascular illness

Pulmonary

• FEV_1 ≥ 60% of predicted AND no obstructive or restrictive pulmonary disease

• No symptoms of respiratory dysfunction

• No other major respiratory illness

Immunologic

• HIV negative

• Epstein-Barr virus positive

• No active systemic infections (including opportunistic infections)

• No form of primary (e.g., autoimmune colitis or Crohn's disease) or secondary immunodeficiency (due to chemotherapy or radiotherapy)

• No prior severe immediate hypersensitivity reaction to any of the study agents including eggs

• No other major illness of the immune system

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 4 month after study participation

• Willing to complete a durable power of attorney (DPA)

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics

• More than 6 weeks since prior MDX-010

Chemotherapy

• Not specified

Endocrine therapy

• See Disease Characteristics

• No concurrent systemic steroid therapy

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• More than 4 weeks since other prior systemic therapy and recovered