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

NCT ID: NCT00853125

Last Updated: 2021-04-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2014-02-22

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.

Conditions

Kidney Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sunitinib plus Irradiated Allogeneic Lymphocytes

Group Type: EXPERIMENTAL

therapeutic allogeneic lymphocytes

Intervention Type: BIOLOGICAL

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 malate

Intervention Type: DRUG

Sunitinib will be administered orally at a dose of 50 mg qd for 4 consecutive weeks followed by 2 weeks off for every cycle.

Interventions

therapeutic allogeneic lymphocytes

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

Intervention Type: BIOLOGICAL

sunitinib malate

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 Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Rutgers Cancer Institute of New Jersey

OTHER

Sponsor Role: collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Roger Strair, MD, PhD

Professor of Medicine, RWJMS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roger Strair, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Rutgers Cancer Institute of New Jersey

Locations

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Countries

United States

Other Identifiers

P30CA072720

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000635763

Identifier Type: OTHER

Identifier Source: secondary_id

0220080220

Identifier Type: OTHER

Identifier Source: secondary_id

080708

Identifier Type: OTHER

Identifier Source: secondary_id

0220080220

Identifier Type: -

Identifier Source: org_study_id