NCT00176501

Brief Summary

RATIONALE: When irradiated donor lymphocytes are infused into the patient they may help the patient's immune system kill tumor cells. PURPOSE: This phase II trial is studying the side effects and how well giving irradiated donor lymphocytes works in treating patients with metastatic kidney cancer.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2004

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
5.4 years until next milestone

Results Posted

Study results publicly available

January 6, 2014

Completed
Last Updated

January 6, 2014

Status Verified

November 1, 2013

Enrollment Period

4 years

First QC Date

September 12, 2005

Results QC Date

November 18, 2013

Last Update Submit

November 18, 2013

Conditions

Kidney Cancer

Keywords

recurrent renal cell cancerclear cell renal cell carcinomastage IV renal cell cancer

Outcome Measures

Primary Outcomes (1)

  • Response Rate

    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.

    5 years

Secondary Outcomes (2)

  • Rate and Kinetics of Clinical/Radiological Response

    5 years

  • Rate of Graft-vs-host Disease

    5 years

Study Arms (1)

Irradiated allogeneic lymphocytes

EXPERIMENTAL
Biological: therapeutic allogeneic lymphocytes

Interventions

therapeutic allogeneic lymphocytesBIOLOGICAL

If a partially HLA-matched donor is identified and other eligibility criteria are met, the patient will receive irradiated lymphocyte infusion(s).

Irradiated allogeneic lymphocytes

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of clear cell renal cell carcinoma * Metastatic disease * Measurable disease * Previously treated with high-dose aldesleukin OR not eligible for or refused such therapy * No brain metastases by MRI or CT scan * HLA-partially matched (e.g., ≥ 2/6 HLA A, B, Dr match) related donor available * Patients who have no partially matched immediate family member available are eligible if they have a fully HLA-matched donor PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Bilirubin ≤ 2 times upper limit of normal * Creatinine clearance ≥ 40 mL/min * AST ≤ 3 times ULN * Cardiac ejection fraction ≥ 45% * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

Kidney NeoplasmsCarcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Results Point of Contact

Title
Dr. Roger Strair, MD, PhD
Organization
Rutgers Cancer Institute of New Jersey
strairrk@cinj.rutgers.edu; rizzoji@cinj.rutgers.edu; zelinsta@cinj.rutgers.edu
732-235-8675

Study Officials

  • Roger Strair, MD, PhD

    Rutgers Cancer Institute of New Jersey

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

August 1, 2004

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

January 6, 2014

Results First Posted

January 6, 2014

Record last verified: 2013-11

Locations

US(1)