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Sponsors and Collaborators: |
Robert H. Lurie Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00278369 |
RATIONALE: Combinations of biological substances in denileukin diftitox may be able to carry tumor-killing substances directly to kidney cancer cells. Interleukin-2 may stimulate the white blood cells to kill kidney cancer cells. Giving denileukin diftitox together with interleukin-2 may kill more tumor cells.
PURPOSE: This randomized phase I trial is studying the side effects of denileukin diftitox and interleukin-2 in treating patients with metastatic kidney cancer.
Condition | Intervention | Phase |
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Kidney Cancer |
Drug: aldesleukin Drug: denileukin diftitox |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | A Pilot Study of Denileukin Diftitox in Combination With High-Dose IL-2 for Patients With Metastatic Renal Cell Carcinoma |
Estimated Enrollment: | 13 |
Study Start Date: | September 2004 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, pilot study.
The first 3 patients enrolled in the study receive high-dose interleukin-2 (IL-2) IV over 15 minutes, 3 times daily, on days 1-5 and 15-19 and denileukin diftitox IV over 15-60 minutes once daily on days 8-10. If no dose-limiting toxicity occurs after receiving denileukin diftitox, subsequent patients are randomized to 1 of 2 treatment arms.
All patients may receive additional treatment with IL-2 alone in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for at least 4 years.
PROJECTED ACCRUAL: A total of 13 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Documented histologically confirmed metastatic renal cell carcinoma
Disease must be measurable as defined by lesions that can be accurately measured in at least one dimension with longest diameter > 20 mm using conventional techniques or > 10 mm with spiral CT scan
The following are considered nonmeasurable lesions:
PATIENT CHARACTERISTICS:
Adequate pulmonary reserve
Pulmonary function tests (PFTs) must be performed within 42 days of IL-2 treatment
PRIOR CONCURRENT THERAPY:
United States, Illinois | |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Recruiting |
Chicago, Illinois, United States, 60611-3013 | |
Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer 312-695-1301 cancer@northwestern.edu |
Study Chair: | Timothy M. Kuzel, MD | Robert H. Lurie Cancer Center |
Study ID Numbers: | CDR0000456408, NU-04U1 |
Study First Received: | January 16, 2006 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00278369 |
Health Authority: | Unspecified |
recurrent renal cell cancer stage IV renal cell cancer clear cell renal cell carcinoma |
Urogenital Neoplasms Renal cancer Urologic Neoplasms Kidney cancer Recurrence Carcinoma Aldesleukin Urologic Diseases Interleukin-2 |
Kidney Neoplasms Denileukin diftitox Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Clear cell renal cell carcinoma Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
Anti-Infective Agents Neoplasms by Histologic Type Anti-HIV Agents Antineoplastic Agents Physiological Effects of Drugs Antiviral Agents Pharmacologic Actions Neoplasms |
Neoplasms by Site Anti-Retroviral Agents Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents |