Irradiated Donor Lymphocytes in Treating Patients With Metastatic Kidney Cancer - Full Text View

Purpose

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.

Condition	Intervention	Phase
Kidney Cancer	Drug: therapeutic allogeneic lymphocytes Procedure: immunoenzyme technique Procedure: laboratory biomarker analysis	Phase II

MedlinePlus related topics:

Cancer Kidney Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label

Official Title:	Immunotherapy for Patients With Renal Cell Carcinoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:

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

Estimated Enrollment:	60
Study Start Date:	March 2005
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00176501

Locations


United States, New Jersey
	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
	New Brunswick, New Jersey, United States, 08903

Sponsors and Collaborators

Cancer Institute of New Jersey

National Cancer Institute (NCI)

Investigators


Principal Investigator:	Roger Strair, MD, PhD	Cancer Institute of New Jersey

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000540187, CINJ-4846
First Received:	September 12, 2005
Last Updated:	October 22, 2008
ClinicalTrials.gov Identifier:	NCT00176501
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):

recurrent renal cell cancer

clear cell renal cell carcinoma

stage IV renal cell cancer

Study placed in the following topic categories:

Urogenital Neoplasms

Renal cancer

Urologic Neoplasms

Kidney cancer

Recurrence

Carcinoma

Urologic Diseases

Kidney Neoplasms

Carcinoma, Renal Cell

Kidney Diseases

Adenocarcinoma

Clear cell renal cell carcinoma

Urinary tract neoplasm

Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 23, 2008

Sponsors and Collaborators:	Cancer Institute of New Jersey National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00176501