Irradiated Donor Lymphocytes in Treating Patients With Metastatic Kidney Cancer

Kidney Cancer Clinical Trial

Official title:

Immunotherapy for Patients With Renal Cell Carcinoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00176501
• Other study ID #: CDR0000540187
• Secondary ID: P30CA072720CINJ
• Status: Terminated
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: November 18, 2013
• Start date: August 2004
• Est. completion date: August 2008

Study information

• Verified date: November 2013
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

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).

Locations

Country	Name	City	State
United States	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate	With regard to responses, this trial will use a two-stage Simon's design optimized to minimize the expected number of patients accrued into the study. The maximum sample size will be 35 subjects. 18 subjects will be accrued during stage 1. If there are 2 or fewer responses during this stage, the trial will be stopped early. If there are 3 or more responses during this stage, an additional 19 patients will be accrued for stage 2. If 6 or fewer responses (out of 35) are observed by the end of the trial, then no further investigation of this therapy is warranted.	5 years	No
Secondary	Rate and Kinetics of Clinical/Radiological Response		5 years	No
Secondary	Rate of Graft-vs-host Disease		5 years	No