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

Primary Purpose

Kidney Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
therapeutic allogeneic lymphocytes
sunitinib malate
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring clear cell renal cell carcinoma, stage IV renal cell cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rutgers Cancer Institute of New Jersey

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sunitinib plus Irradiated Allogeneic Lymphocytes

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 27, 2009
Last Updated
April 23, 2021
Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT00853125
Brief Title
Sunitinib and Irradiated Donor Lymphocytes in Treating Patients With Metastatic Kidney Cancer
Official Title
Phase II Study of Sunitinib Plus Extended Courses of Irradiated Allogeneic Lymphocytes for Patients With Renal Cell Carcinoma (SPECIAL Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual
Study Start Date
February 2009 (undefined)
Primary Completion Date
February 22, 2014 (Actual)
Study Completion Date
February 22, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer
Keywords
clear cell renal cell carcinoma, stage IV renal cell cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sunitinib plus Irradiated Allogeneic Lymphocytes
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
therapeutic allogeneic lymphocytes
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
sunitinib malate
Intervention Description
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 Measure Information:
Title
Progression-free Survival
Description
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.
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.
Secondary Outcome Measure Information:
Title
Response Rate
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger Strair, MD, PhD
Organizational Affiliation
Rutgers Cancer Institute of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States

12. IPD Sharing Statement

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

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