Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002589 |
RATIONALE: Treating a person's lymphocytes with interleukin-2 and monoclonal antibody may help them kill more cancer cells when they are put back in the body.
PURPOSE: This phase II trial is studying how well lymphocyte therapy works in treating patients with stage III or stage IV kidney cancer.
Condition | Intervention | Phase |
---|---|---|
Kidney Cancer |
Drug: aldesleukin Drug: muromonab-CD3 Drug: therapeutic autologous lymphocytes Procedure: adjuvant therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Adjuvant Autolymphocyte Therapy (ALT) For Patients With Non-Metastatic Renal Cell Carcinoma |
Estimated Enrollment: | 90 |
Study Start Date: | July 1994 |
OBJECTIVES:
OUTLINE: Patients are stratified according to postnephrectomy interval (less than 3 months vs more than 3 months), extent of lymph node involvement (N1 vs N2-N3), interleukin-1 concentration in initial autologous lymphocyte culture (less than 500 pg/mL vs greater than 500 pg/mL), and prenephrectomy treatment.
Mononuclear cells are collected by apheresis on day 1 and cultured with interleukin-2 and monoclonal antibody OKT3. After cellular production, the autologous lymphocytes are reinfused over at least 30 minutes. Treatment repeats monthly for 6 months and then every 3 months for 6 months in the absence of unacceptable toxicity.
Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 5 years.
PROJECTED ACCRUAL: A total of 10-90 patients will accrued for this study within 3 years.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
No uncontrolled or severe cardiac disease, e.g.:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
No concurrent therapy with the following:
Radiotherapy:
Surgery:
United States, Wisconsin | |
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center | |
Milwaukee, Wisconsin, United States, 53201-2901 |
Study Chair: | John P. Hanson, MD | Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center |
Study ID Numbers: | CDR0000063744, STLMC-BRM-9401, NCI-V94-0514 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00002589 |
Health Authority: | United States: Federal Government |
stage III renal cell cancer stage IV renal cell cancer recurrent renal cell cancer |
Urogenital Neoplasms Renal cancer Urologic Neoplasms Kidney cancer Recurrence Muromonab-CD3 Carcinoma Aldesleukin |
Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
Anti-Infective Agents Neoplasms by Histologic Type Anti-HIV Agents Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Immunosuppressive Agents |
Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Anti-Retroviral Agents Therapeutic Uses |