Irradiated Donor Lymphocytes in Treating Patients With Metastatic Kidney Cancer
This study has been terminated.
(Slow accrual)
Sponsor:
University of Medicine and Dentistry New Jersey
Collaborator:
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
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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 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Immunotherapy for Patients With Renal Cell Carcinoma |
Resource links provided by NLM:
Further study details as provided by University of Medicine and Dentistry New Jersey:
Primary Outcome Measures:
- Response rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 3 |
| Study Start Date: | August 2004 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
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).
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
Investigators
| Principal Investigator: | Roger Strair, MD, PhD | Cancer Institute of New Jersey |
More Information
No publications provided
| Responsible Party: | Roger Strair, MD, PhD, The Cancer Institute of New Jersey at the University of Medicine and Dentistry of NJ |
| ClinicalTrials.gov Identifier: | NCT00176501 History of Changes |
| Other Study ID Numbers: | CDR0000540187, P30CA072720, CINJ# 080410-4846 |
| Study First Received: | September 12, 2005 |
| Last Updated: | April 14, 2011 |
| 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:
|
Carcinoma, Renal Cell Kidney Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on May 21, 2013