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

Sponsor:	University of Medicine and Dentistry New Jersey
Collaborator:	National Cancer Institute (NCI)
Information provided by:	University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:	NCT00176501

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	Biological: therapeutic allogeneic lymphocytes Other: immunoenzyme technique Other: laboratory biomarker analysis	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Immunotherapy for Patients With Renal Cell Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Kidney Cancer

U.S. FDA Resources

Further study details as provided by University of Medicine and Dentistry New Jersey:

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:	August 2004
Study Completion Date:	August 2008
Primary Completion Date:	August 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

University of Medicine and Dentistry New Jersey

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Roger Strair, MD, PhD

Cancer Institute of New Jersey

More Information

Additional Information:

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

No publications provided

Responsible Party:	( Roger Strair, MD, PhD )
Study ID Numbers:	CDR0000540187, P30CA072720, CINJ# 080410-4846
Study First Received:	September 12, 2005
Last Updated:	November 12, 2009
ClinicalTrials.gov Identifier:	NCT00176501 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Medicine and Dentistry New Jersey:

recurrent renal cell cancer
clear cell renal cell carcinoma
stage IV renal cell cancer

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell

Urogenital Neoplasms
Kidney Diseases
Urologic Neoplasms
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on November 27, 2009