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

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ClinicalTrials.gov Identifier: NCT00853125
Recruitment Status : Terminated (Slow accrual)
First Posted : March 2, 2009
Results First Posted : May 31, 2019
Last Update Posted : May 31, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Rutgers Cancer Institute of New Jersey
Information provided by (Responsible Party):
Roger Strair, MD, PhD, Rutgers, The State University of New Jersey

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.


Condition or disease Intervention/treatment Phase
Kidney Cancer Biological: therapeutic allogeneic lymphocytes Drug: sunitinib malate Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : February 2009
Actual Primary Completion Date : February 22, 2014
Actual Study Completion Date : February 22, 2014


Arm Intervention/treatment
Experimental: Sunitinib plus Irradiated Allogeneic Lymphocytes 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.




Primary Outcome Measures :
  1. Progression-free Survival [ Time Frame: 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. ]
    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.


Secondary Outcome Measures :
  1. Response Rate [ Time Frame: 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. ]
    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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00853125


Locations
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United States, New Jersey
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Sponsors and Collaborators
Rutgers, The State University of New Jersey
National Cancer Institute (NCI)
Rutgers Cancer Institute of New Jersey
Investigators
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Principal Investigator: Roger Strair, MD, PhD Rutgers Cancer Institute of New Jersey

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Responsible Party: Roger Strair, MD, PhD, Professor of Medicine, RWJMS, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT00853125     History of Changes
Other Study ID Numbers: 080708
P30CA072720 ( U.S. NIH Grant/Contract )
CDR0000635763 ( Other Identifier: NCI )
0220080220 ( Other Identifier: IRB )
First Posted: March 2, 2009    Key Record Dates
Results First Posted: May 31, 2019
Last Update Posted: May 31, 2019
Last Verified: May 2019
Keywords provided by Roger Strair, MD, PhD, Rutgers, The State University of New Jersey:
clear cell renal cell carcinoma
stage IV renal cell cancer
Additional relevant MeSH terms:
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Protein Kinase Inhibitors
Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Kidney Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action