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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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Kidney Cancer
Interventions Biological: therapeutic allogeneic lymphocytes
Drug: sunitinib malate
Enrollment 10
Recruitment Details Subjects were recruited through the Rutgers Cancer Institute of New Jersey. The study was open to accrual on 02/03/2009 and closed to accrual on 05/07/2013 because of slow accrual.
Pre-assignment Details We are reporting results on 10 eligible patients. Five patients were deemed ineligible.
Arm/Group Title Sunitinib Plus Irradiated Allogeneic Lymphocytes
Hide Arm/Group Description

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

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.

Period Title: Overall Study
Started 10
Completed 9
Not Completed 1
Reason Not Completed
Study participant's donor was CMV +             1
Arm/Group Title Sunitinib Plus Irradiated Allogeneic Lymphocytes
Hide Arm/Group Description

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

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.

Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
  30.0%
>=65 years
7
  70.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
4
  40.0%
Male
6
  60.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
10
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
  20.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
8
  80.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
 100.0%
1.Primary Outcome
Title Progression-free Survival
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated early due to slow accrual.
Arm/Group Title Sunitinib Plus Irradiated Allogeneic Lymphocytes
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 7
Median (Full Range)
Unit of Measure: days
137
(15 to 489)
2.Secondary Outcome
Title Response Rate
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sunitinib Plus Irradiated Allogeneic Lymphocytes
Hide Arm/Group Description:

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.

Sunitinib malate: Sunitinib will be administered orally at adose 50 mg qd for 4 consecutive weeks followed by 2 weeks off for every cycle.

Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: participants
PR 3
Progressive Disease 2
Stable Disease 5
Time Frame Adverse events were collected over a period of 336 days per patient.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sunitinib Plus Irradiated Allogeneic Lymphocytes
Hide Arm/Group Description

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

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.

All-Cause Mortality
Sunitinib Plus Irradiated Allogeneic Lymphocytes
Affected / at Risk (%)
Total   1/10 (10.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Sunitinib Plus Irradiated Allogeneic Lymphocytes
Affected / at Risk (%)
Total   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sunitinib Plus Irradiated Allogeneic Lymphocytes
Affected / at Risk (%)
Total   0/10 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Roger Strair, MD, PhD
Organization: Rutgers Cancer Institute of New Jersey
Phone: 732-235-7298
EMail: strairrk@cinj.rutgers.edu
Layout table for additonal information
Responsible Party: Roger Strair, MD, PhD, 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 Submitted: February 27, 2009
First Posted: March 2, 2009
Results First Submitted: April 17, 2017
Results First Posted: May 31, 2019
Last Update Posted: May 31, 2019