Clinical trial NCT00853125: Sunitinib and Irradiated Donor Lymphocytes in Treating Patients With Metastatic Kidney Cancer
Official title: Phase II Study of Sunitinib Plus Extended Courses of Irradiated Allogeneic Lymphocytes for Patients With Renal Cell Carcinoma (SPECIAL Trial)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Kidney Cancer
Keywords: clear cell renal cell carcinoma
stage IV renal cell cancer
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Rutgers Cancer Institute of New Jersey
First posted: 2009-03-02
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Progression-free Survival
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, on average up to 1 year.
Secondary outcomes:
measure: Response Rate
timeFrame: Best responseFrom date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year.
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Roger Strair, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: