Clinical trial NCT00176501: Irradiated Donor Lymphocytes in Treating Patients With Metastatic Kidney Cancer
Official title: Immunotherapy for Patients With Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Kidney Cancer
Keywords: recurrent renal cell cancer
clear cell renal cell carcinoma
stage IV renal cell cancer
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-09-15
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Response Rate
timeFrame: 5 years
Secondary outcomes:
measure: Rate and Kinetics of Clinical/Radiological Response
timeFrame: 5 years
measure: Rate of Graft-vs-host Disease
timeFrame: 5 years
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
state: New Jersey
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Roger Strair, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: