Sunitinib and Irradiated Donor Lymphocytes in Treating Patients With Metastatic Kidney Cancer
Condition: Kidney Cancer
MeSH terms: Kidney Neoplasms; Carcinoma, Renal Cell
Intervention: therapeutic allogeneic lymphocytes; sunitinib malate
Intervention description: Patients with a partially HLA-matched family member who can serve as a hematopoietic stem cell transplant donor will receive partially HLA-matched irradiated donor lymphocytes approximately every 8 weeks depending upon response; Sunitinib will be administered orally at a dose of 50 mg qd for 4 consecutive weeks followed by 2 weeks off for every cycle.
Intervention MeSH terms: Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: clear cell renal cell carcinoma; stage IV renal cell cancer

Summary:

      RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth and by blocking blood flow to the tumor. Infusing irradiated donor
      lymphocytes into the patient may help the patient's immune system kill tumor cells. Giving
      sunitinib together with irradiated donor lymphocytes may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving sunitinib together with irradiated
      donor lymphocytes works in treating patients with metastatic kidney cancer.
    

Eligibility 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