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

Rutgers The State University of New Jersey

Status and phase

Terminated

Phase 2

Conditions

Kidney Cancer

Treatments

Biological: therapeutic allogeneic lymphocytes

Drug: sunitinib malate

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00853125

080708 (Other Identifier)

P30CA072720 (U.S. NIH Grant/Contract)

0220080220 (Other Identifier)

CDR0000635763 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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