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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Rutgers Cancer Institute of New Jersey
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00853125
First received: February 27, 2009
Last updated: September 26, 2014
Last verified: September 2014
  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 Rutgers, The State University of 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
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00853125

Locations
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
Rutgers Cancer Institute of New Jersey
Investigators
Principal Investigator: Roger Strair, MD, PhD Rutgers Cancer Institute of New Jersey
  More Information

Additional Information:
No publications provided

Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT00853125     History of Changes
Other Study ID Numbers: 080708, P30CA072720, CDR0000635763, 0220080220
Study First Received: February 27, 2009
Last Updated: September 26, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Rutgers, The State University of New Jersey:
clear cell renal cell carcinoma
stage IV renal cell cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Kidney Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Sunitinib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014