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Immunotherapy for Patients With Renal Cell Carcinoma


Phase 2
18 Years
75 Years
Not Enrolling
Both
Kidney Cancer

Thank you

Trial Information

Immunotherapy for Patients With Renal Cell Carcinoma


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Response rate

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Roger Strair, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institute of New Jersey

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000540187

NCT ID:

NCT00176501

Start Date:

August 2004

Completion Date:

August 2008

Related Keywords:

  • Kidney Cancer
  • recurrent renal cell cancer
  • clear cell renal cell carcinoma
  • stage IV renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

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