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

NCT00853125 | Terminated Phase 2 Results DMC

• 4 other identifiers: 0220080220P30CA072720CDR0000635763080708
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Cancer

Keywords

clear cell renal cell carcinoma; stage IV renal cell cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Response Rate

  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.

Study Arms (1)

Sunitinib plus Irradiated Allogeneic Lymphocytes

EXPERIMENTAL

Biological: therapeutic allogeneic lymphocytes; Drug: sunitinib malate

Interventions

therapeutic allogeneic lymphocytes 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 plus Irradiated Allogeneic Lymphocytes

sunitinib malate 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.

Sunitinib plus Irradiated Allogeneic Lymphocytes

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Cancer Institute (NCI): collaborator
• Rutgers Cancer Institute of New Jersey: collaborator

Study Sites (1)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Roger Strair, MD, PhD
• Organization: Rutgers Cancer Institute of New Jersey

strairrk@cinj.rutgers.edu

732-235-7298

Study Officials

• Roger Strair, MD, PhD

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, RWJMS

Study Record Dates

• First Submitted: February 27, 2009
• First Posted: March 2, 2009
• Study Start: February 1, 2009
• Primary Completion: February 22, 2014
• Study Completion: February 22, 2014
• Last Updated: April 27, 2021
• Results First Posted: May 31, 2019

Record last verified: 2021-04

Locations

US (1)