Irradiated Donor Lymphocytes in Treating Patients With Metastatic Kidney Cancer

Rutgers The State University of New Jersey

Status and phase: Terminated; Phase 2

Conditions: Kidney Cancer

Treatments: Biological: therapeutic allogeneic lymphocytes

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00176501

P30CA072720 (U.S. NIH Grant/Contract)

CINJ #080410 (Other Identifier)

CDR0000540187

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Irradiated allogeneic lymphocytes

Experimental group

Treatment:

Biological: therapeutic allogeneic lymphocytes