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

Kidney Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00853125
• Other study ID #: 0220080220
• Secondary ID: P30CA072720CDR00
• Status: Terminated
• Phase: Phase 2
• Start date: February 2009
• Est. completion date: February 22, 2014

Study information

• Verified date: April 2021
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: February 22, 2014
• Est. primary completion date: February 22, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

Biological:
• 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

Drug:
• 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.

Locations

Country	Name	City	State
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival	Determined as the time from treatment with combination sunitinib with irradiated allogeneic lymphocytes to progressive disease or death whichever occurred first. Progression is determined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0) as 20% increase in the sum of the of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.	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	Response Rate	Per response evaluation criteria in solid tumors criteria (RECIST v 1.0) for target lesions and assessed by MRI; Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; Stable disease - not meeting criteria for response or progression.	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.