Sunitinib and Irradiated Donor Lymphocytes in Treating Patients With Metastatic Kidney Cancer
This study is currently recruiting participants.
Verified June 2012 by University of Medicine and Dentistry New Jersey
Sponsor:
University of Medicine and Dentistry New Jersey
Collaborator:
Information provided by (Responsible Party):
University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:
NCT00853125
First received: February 27, 2009
Last updated: June 12, 2012
Last verified: June 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Cancer |
Biological: therapeutic allogeneic lymphocytes Drug: sunitinib malate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Sunitinib Plus Extended Courses of Irradiated Allogeneic Lymphocytes for Patients With Renal Cell Carcinoma (SPECIAL Trial) |
Resource links provided by NLM:
Further study details as provided by University of Medicine and Dentistry New Jersey:
Primary Outcome Measures:
- Progression-free survival [ Time Frame: Treatment start date to date of progression ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Rates and kinetics of clinical/radiographic response [ Time Frame: Treatment start date to best response ] [ Designated as safety issue: No ]
- Toxicity as assessed by NCI CTCAE v3.0 [ Time Frame: Treatment start date to off study ] [ Designated as safety issue: Yes ]
- Stable disease at 6 months [ Time Frame: Treatment start date to 6 months ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Treatment start date to date of death ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 35 |
| Study Start Date: | February 2009 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
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.
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| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00853125
Locations
| United States, New Jersey | |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | Recruiting |
| New Brunswick, New Jersey, United States, 08903 | |
| Contact: Clinical Trials Office - Cancer Institute of New Jersey 732-235-8675 | |
Sponsors and Collaborators
University of Medicine and Dentistry New Jersey
Investigators
| Principal Investigator: | Roger Strair, MD, PhD | Cancer Institute of New Jersey |
More Information
Additional Information:
No publications provided
| Responsible Party: | University of Medicine and Dentistry New Jersey |
| ClinicalTrials.gov Identifier: | NCT00853125 History of Changes |
| Other Study ID Numbers: | 080708, P30CA072720, CDR0000635763 |
| Study First Received: | February 27, 2009 |
| Last Updated: | June 12, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Medicine and Dentistry New Jersey:
|
clear cell renal cell carcinoma stage IV renal cell cancer |
Additional relevant MeSH terms:
|
Carcinoma, Renal Cell Kidney Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases |
Urologic Diseases Sunitinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on May 22, 2013