Fludarabine Followed By Adoptive Immunotherapy in Treating Patients With Stage IV Melanoma

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Biological therapies such as cellular adoptive immunotherapy use different ways to stimulate the immune system and stop cancer cells from growing. Fludarabine may help the immune system kill more cancer cells.

PURPOSE: Phase I trial to study the effectiveness of fludarabine followed by cellular adoptive immunotherapy in treating patients who have metastatic melanoma.

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

Details

• Lead Sponsor: Fred Hutchinson Cancer Research Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Fludarabine; Fludarabine phosphate; Vidarabine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed metastatic melanoma

• Stage IV disease

• HLA-A2 or -A3-expressing disease

• Bidimensionally measurable residual disease by palpation or radiographic imaging (e.g., x-ray or CT scan)

• No CNS metastases

• Previously treated CNS involvement allowed provided there is no evidence of CNS disease at least 2 months after completion of therapy

PATIENT CHARACTERISTICS:

Age

• 18 to 75

Performance status

• Karnofsky 80-100%

Life expectancy

• More than 6 months

Hematopoietic

• Platelet count > 100,000/mm^3

• Absolute neutrophil count > 2,000/mm^3

Hepatic

• SGOT no greater than 3 times upper limit of normal

• Bilirubin no greater than 1.6 mg/dL

• INR no greater than 1.5 times normal

Renal

• Creatinine no greater than 2.0 mg/dL OR

• Creatinine clearance at least 60 mL/min

Cardiovascular

• No congestive heart failure

• No clinically significant hypotension

• No symptoms of coronary artery disease

• No cardiac arrhythmia by EKG requiring drug therapy

Pulmonary

• No clinically significant pulmonary dysfunction

• FEV_1 at least 1.0 L*

• DLCO at least 45%* NOTE: *For patients with a history of pulmonary dysfunction

Immunologic

• No active infection

• No oral temperature greater than 38.2°C within the past 48 hours

• No systemic infection requiring chronic maintenance or suppressive therapy

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent immunotherapy (e.g., interleukins, interferons, melanoma vaccines, IV immunoglobulins, expanded polyclonal tumor-infiltrating lymphocytes, or lymphokine-activated killer therapy)

Chemotherapy

• At least 3 weeks since prior chemotherapy (standard or experimental)

Endocrine therapy

• No concurrent steroids

Radiotherapy

• At least 3 weeks since prior radiotherapy

Surgery

• Not specified

Other

• At least 3 weeks since prior immunosuppressive therapy

• No concurrent pentoxifylline

• No other concurrent investigational agents