Trial Outcomes & Findings for Irradiated Donor Lymphocytes in Treating Patients With Metastatic Kidney Cancer (NCT NCT00176501)

NCT ID: NCT00176501

Last Updated: 2014-01-06

Results Overview

With regard to responses, this trial will use a two-stage Simon's design optimized to minimize the expected number of patients accrued into the study. The maximum sample size will be 35 subjects. 18 subjects will be accrued during stage 1. If there are 2 or fewer responses during this stage, the trial will be stopped early. If there are 3 or more responses during this stage, an additional 19 patients will be accrued for stage 2. If 6 or fewer responses (out of 35) are observed by the end of the trial, then no further investigation of this therapy is warranted.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 3 participants
• Primary outcome timeframe: 5 years
• Results posted on: 2014-01-06

Participant Flow

Three subjects were enrolled from March 2005 through February 2006 at Rutgers Cancer Institute of New Jersey, a comprehensive cancer center.

Participant milestones

Measure	Irradiated Allogeneic Lymphocytes therapeutic allogeneic lymphocytes : If a partially HLA-matched donor is identified and other eligibility criteria are met, the patient will receive irradiated lymphocyte infusion(s).
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Irradiated Donor Lymphocytes in Treating Patients With Metastatic Kidney Cancer

Baseline characteristics by cohort

Measure	Irradiated Allogeneic Lymphocytes n=3 Participants therapeutic allogeneic lymphocytes : If a partially HLA-matched donor is identified and other eligibility criteria are met, the patient will receive irradiated lymphocyte infusion(s).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	55.3 years STANDARD_DEVIATION 7.1 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 years

Population: The study was closed early due to slow accrual and insufficient data were collected to analyse this outcome measure.

With regard to responses, this trial will use a two-stage Simon's design optimized to minimize the expected number of patients accrued into the study. The maximum sample size will be 35 subjects. 18 subjects will be accrued during stage 1. If there are 2 or fewer responses during this stage, the trial will be stopped early. If there are 3 or more responses during this stage, an additional 19 patients will be accrued for stage 2. If 6 or fewer responses (out of 35) are observed by the end of the trial, then no further investigation of this therapy is warranted.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Population: The study was closed early due to slow accrual and insufficient data were collected to analyse this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Population: The study was closed early due to slow accrual and insufficient data were collected to analyse this outcome measure.

Outcome measures

Outcome data not reported

Adverse Events

Irradiated Allogeneic Lymphocytes

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Irradiated Allogeneic Lymphocytes n=3 participants at risk therapeutic allogeneic lymphocytes : If a partially HLA-matched donor is identified and other eligibility criteria are met, the patient will receive irradiated lymphocyte infusion(s).
Gastrointestinal disorders Diarrhea	33.3% 1/3 • Number of events 1 • 5 years
Blood and lymphatic system disorders Positive lymphocyte culture	33.3% 1/3 • Number of events 2 • 5 years
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 2 • 5 years
Gastrointestinal disorders Nausea	33.3% 1/3 • Number of events 1 • 5 years

Other adverse events

Measure	Irradiated Allogeneic Lymphocytes n=3 participants at risk therapeutic allogeneic lymphocytes : If a partially HLA-matched donor is identified and other eligibility criteria are met, the patient will receive irradiated lymphocyte infusion(s).
General disorders Fatigue (asthenia, lethargy, malaise)	66.7% 2/3 • Number of events 2 • 5 years
General disorders Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)	66.7% 2/3 • Number of events 4 • 5 years
Gastrointestinal disorders Diarrhea	33.3% 1/3 • Number of events 2 • 5 years
Gastrointestinal disorders Nausea	33.3% 1/3 • Number of events 1 • 5 years
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 2 • 5 years
Investigations Alkaline phosphatase	33.3% 1/3 • Number of events 1 • 5 years
Blood and lymphatic system disorders ALT, SGPT (serum glutamic pyruvic transaminase)	33.3% 1/3 • Number of events 2 • 5 years
Blood and lymphatic system disorders AST, SGOT (serum glutamic oxaloacetic transaminase)	33.3% 1/3 • Number of events 1 • 5 years
General disorders Pain - Back	33.3% 1/3 • Number of events 1 • 5 years
General disorders Pain - Kidney	33.3% 1/3 • Number of events 1 • 5 years

Additional Information

Dr. Roger Strair, MD, PhD

Rutgers Cancer Institute of New Jersey

Phone: 732-235-8675

Email: strairrk@cinj.rutgers.edu; rizzoji@cinj.rutgers.edu; zelinsta@cinj.rutgers.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place