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

Phase 2
18 Years
75 Years
Open (Enrolling)
Kidney Cancer

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Trial Information

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



- Determine progression-free survival of patients with metastatic clear cell renal cell
carcinoma treated with sunitinib and irradiated allogeneic lymphocytes.


- 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.

Inclusion 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

Treatment start date to date of progression

Safety Issue:


Principal Investigator

Roger Strair, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institute of New Jersey


United States: Food and Drug Administration

Study ID:




Start Date:

February 2009

Completion Date:

Related Keywords:

  • Kidney Cancer
  • clear cell renal cell carcinoma
  • stage IV renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms



Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School New Brunswick, New Jersey  08903