Phase II Study of Sunitinib Plus Extended Courses of Irradiated Allogeneic Lymphocytes for Patients With Renal Cell Carcinoma (SPECIAL Trial)

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed renal cell carcinoma

- Primary lesion or metastatic site demonstrating clear cell variant with < 25% of
any other histology

- Radiographically measurable disease by RECIST criteria

- Initiated treatment with sunitinib malate ≤ 6 weeks ago

- No radiographically detectable brain metastases by MRI or CT scan

- HLA-partially matched related donor available, as determined by serologic and/or DNA
typing

- Appropriate HLA match (≥ 2/6 HLA A, B, DR match)

PATIENT CHARACTERISTICS:

- ECOG performance status 0-1

- Absolute neutrophil count > 1,500/mm³

- Platelet count > 100,000/mm³

- Total bilirubin ≤ 2.0 times upper limit of normal (ULN)

- AST ≤ 3.0 times ULN

- Calculated creatinine clearance ≥ 40 mL/min

- Cardiac ejection fraction ≥ 50%

- QTc interval < 500 msec by EKG

- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception

- No known HIV positivity

- None of the following within the past 6 months:

- Myocardial infarction

- Severe/unstable angina

- Coronary/peripheral artery bypass graft

- Symptomatic congestive heart failure

- Cerebrovascular accident or transient ischemic attack

- Pulmonary embolism

- No ongoing ventricular cardiac dysrhythmias ≥ grade 2, according to NCI CTCAE v3.0

- No history of serious ventricular arrhythmia (e.g., ventricular tachycardia > 3 beats
in a row)

- No ongoing atrial fibrillation

- No other malignancies within the past 3 years, other than basal cell skin cancer,
squamous cell skin cancer, in situ cervical cancer, or ductal or lobular carcinoma in
situ of the breast

- No other concurrent serious illness

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior systemic therapy for metastatic renal cell carcinoma

- No prior immunotherapy

- No prior VEGF-targeted or mTOR-targeted therapies

- No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (e.g., phenytoin,
carbamazepine, or phenobarbital), St. John's wort, ketoconazole, dexamethasone,
dysrhythmic drugs (e.g., terfenadine, quinidine, procainamide, sotalol, probucol,
bepridil, indapamide, or flecainide), haloperidol, risperidone, rifampin, grapefruit,
or grapefruit juice

- No other concurrent investigational anticancer agents