Sunitinib and Irradiated Donor Lymphocytes in Treating Patients With Metastatic Kidney Cancer

Rutgers The State University of New Jersey logo

Rutgers The State University of New Jersey

Status and phase

Phase 2


Kidney Cancer


Biological: therapeutic allogeneic lymphocytes
Drug: sunitinib malate

Study type


Funder types



080708 (Other Identifier)
P30CA072720 (U.S. NIH Grant/Contract)
0220080220 (Other Identifier)
CDR0000635763 (Other Identifier)

Details and patient eligibility


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.

Full description

OBJECTIVES: Primary Determine progression-free survival of patients with metastatic clear cell renal cell carcinoma treated with sunitinib and irradiated allogeneic lymphocytes. Secondary Determine rates and kinetics of clinical/radiographic response in these patients. Determine toxicities associated with treatment in these patients. Assess stable disease at 6 months in these patients. Assess overall survival of these patients. OUTLINE: Patients receive oral sunitinib malate once daily for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Beginning with course 2 of sunitinib malate, patients also receive irradiated allogeneic lymphocytes IV over 1 hour every 8-16 weeks for up to 6 infusions in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for 60 days.


10 patients




18 to 75 years old


No Healthy Volunteers

Inclusion and exclusion criteria


  • 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)


  • 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


  • 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

Trial design

Primary purpose




Interventional model

Single Group Assignment


None (Open label)

10 participants in 1 patient group

Sunitinib plus Irradiated Allogeneic Lymphocytes
Experimental group
Drug: sunitinib malate
Biological: therapeutic allogeneic lymphocytes

Trial contacts and locations



Data sourced from

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