Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Metastatic Kidney Cancer

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus peripheral stem cell transplantation in treating patients who have metastatic kidney cancer or melanoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cyclophosphamide; Fludarabine; Fludarabine phosphate

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed metastatic renal cell carcinoma or melanoma that is not potentially curable by surgery

• Evaluable disease or bidimensionally measurable disease on physical examination, chest x-ray, CT scan, or MRI

• Measurable disease by radiography must be reproducible

• Bony disease or effusions not measurable

• No active CNS disease currently receiving radiotherapy or steroids

• No effusion or ascites of more than 1 liter prior to drainage

• HLA 5/6 or 6/6 matched sibling donor available

• No known hypersensitivity to E. coli derived products

• No active infection

• No health condition that would preclude donation

PATIENT CHARACTERISTICS:

Age:

• 18 to 65

Performance status:

• CALGB 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Bilirubin no greater than 2.0 g/dL

• No active hepatitis

Renal:

• Creatinine no greater than 2.0 mg/dL OR

• Creatinine clearance greater than 50 mL/min

Cardiovascular:

• LVEF at least 50%

Pulmonary:

• DLCO at least 50% of predicted

Other:

• No active infection

• HIV negative

• No psychological problem that would preclude study compliance

• No known hypersensitivity to E. coli derived products

• Not pregnant or nursing

• Negative pregnancy test

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• At least 4 weeks since prior systemic chemotherapy

Endocrine therapy:

• See Disease Characteristics

Radiotherapy:

• See Disease Characteristics

• At least 4 weeks since prior radiotherapy

Surgery:

• See Disease Characteristics