Irradiated Donor Lymphocytes in Treating Patients With Metastatic Kidney Cancer

This study has been terminated.

(Slow accrual)

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by:

University of Medicine and Dentistry New Jersey

ClinicalTrials.gov Identifier:

NCT00176501

First received: September 12, 2005

Last updated: April 14, 2011

Last verified: April 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

April 14, 2011

Start Date ^ICMJE

August 2004

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Response rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

This clinical trial will be a comparative study of 2 regimens for patients with metastatic renal cell carcinoma.

Change History

Complete list of historical versions of study NCT00176501 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Rate and kinetics of clinical/radiological response [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Toxicity [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Rate of graft-vs-host disease [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Determination of rates and kinetics of clinical/radiographic response in each of the treatment arms;
Determination of toxicities associated with each of the treatment arms.
Determination of rates of graft versus host disease in each of the treatment arms;

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Irradiated Donor Lymphocytes in Treating Patients With Metastatic Kidney Cancer

Official Title ^ICMJE

Immunotherapy for Patients With Renal Cell Carcinoma

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.

Detailed Description

OBJECTIVES:

Determine the response rate in patients with metastatic renal cell carcinoma treated with HLA-partially matched related donor lymphocytes.
Determine the rate and kinetics of clinical/radiological response in patients treated with this regimen.
Determine the toxicity of this regimen in these patients.
Determine the rates of graft-vs-host disease in patients treated with this regimen.

OUTLINE: Patients receive irradiated donor lymphocytes IV over 1 hour on day 0. Treatment repeats every 8-16 weeks for up to 6 donor lymphocyte infusions in the absence of disease progression or unacceptable toxicity.

Blood is collected periodically for research studies, including immunophenotypic analysis of cells and assay for cytotoxic T-lymphocytes and natural killer-cell activity against target cells.

After completion of study treatment, patients are followed for 60 days.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Kidney Cancer

Intervention ^ICMJE

Biological: 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).

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

August 2008

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00176501

Other Study ID Numbers ^ICMJE

CDR0000540187, P30CA072720, CINJ# 080410-4846

Has Data Monitoring Committee

Yes

Responsible Party

Roger Strair, MD, PhD, The Cancer Institute of New Jersey at the University of Medicine and Dentistry of NJ

Study Sponsor ^ICMJE

University of Medicine and Dentistry New Jersey

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Principal Investigator:

Roger Strair, MD, PhD

Cancer Institute of New Jersey

Information Provided By

University of Medicine and Dentistry New Jersey

Verification Date

April 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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