Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic or Unresectable Kidney Cancer

• Status: Completed
• Trial end date: 2006-06-01
• 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 followed by donor peripheral stem cell transplantation in treating patients who have metastatic or unresectable kidney cancer.

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

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cyclophosphamide; Fludarabine; Fludarabine phosphate; Lenograstim; Methotrexate; Tacrolimus

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed renal cell carcinoma (RCC)

• Clear cell or papillary RCC

• Granular tumors with sarcomatoid features

• No purely sarcomatoid RCC, chromophobic RCC, or oncocytoma

• No transitional cell carcinoma of the renal pelvis and collecting systems

• Metastatic or unresectable disease

• At least 1 measurable lesion

• At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan

• The following are not considered measurable:

• Bone lesions

• Leptomeningeal disease

• Ascites

• Pleural/pericardial effusion

• Lymphangitis cutis/pulmonis

• Abdominal masses that are not confirmed and followed by imaging techniques

• Cystic lesions

• Primary bladder masses

• Progressive disease after interferon alfa and/or interleukin-2 for metastatic RCC OR intolerance to these therapies

• No prior or concurrent CNS metastases

• Negative MRI of the brain within the past 28 days

• Must have HLA-identical (6/6) sibling donor

PATIENT CHARACTERISTICS:

Age:

• 60 and under

Performance status:

• ECOG 0-1

Life expectancy:

• More than 6 months

Hematopoietic:

• Granulocyte count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 2 times upper limit of normal (ULN)

• AST no greater than 3 times ULN

Renal:

• Creatinine clearance at least 40 mL/min

Cardiovascular:

• LVEF at least 45% by MUGA or echocardiogram

Pulmonary:

• DLCO greater than 40% of predicted (corrected for hemoglobin level)

• No symptomatic pulmonary disease

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• HIV negative

• No known hypersensitivity to E. coli-derived products

• No uncontrolled diabetes mellitus

• No active serious infection

• No other concurrent malignancy except non-melanoma skin cancer or other malignancy that has less than a 30% risk of relapse after completion of therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• See Disease Characteristics

• No concurrent sargramostim (GM-CSF)

• Concurrent epoetin alfa allowed

Chemotherapy:

• No other concurrent chemotherapy

Endocrine therapy:

• At least 28 days since prior hormonal therapy (e.g., megestrol, corticosteroids, or anti-estrogen therapy)

• Concurrent steroids allowed for adrenal failure, graft-versus-host disease, or other nondisease-related conditions (e.g., insulin for diabetes)

Radiotherapy:

• At least 14 days since prior radiotherapy

Surgery:

• At least 14 days since prior surgery

Other:

• At least 28 days since prior systemic therapy for RCC

• Recovered from prior therapy