Adoptive Immunotherapy by Allogeneic Stem Cell Transplantation for Metastatic Renal Cell Carcinoma: A Phase II Study

Inclusion 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