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Biomed 101 and Interleukin-2 in Treating Patients With Kidney Cancer

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: March 7, 2000
Last updated: March 25, 2013
Last verified: January 2008

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer cells. Biomed 101 may protect normal cells from the side effects of interleukin-2.

PURPOSE: Phase I trial to study the effectiveness of Biomed 101 in treating patients receiving interleukin-2 for kidney cancer.

Condition Intervention Phase
Drug Extravasation Kidney Cancer Biological: aldesleukin Drug: Biomed 101 Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase IB Open-Label Rising-Dose Study of Biomed 101 in Patients Treated With Interleukin-2 for Malignancy

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: December 2000
Study Completion Date: December 2002
Primary Completion Date: December 2002 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Evaluate the safety and maximum tolerated dose of Biomed 101 in patients with renal cell cancer currently treated with interleukin-2 (IL-2). II. Evaluate the effect of different doses of Biomed 101 on the incidence and severity of IL-2 related toxicities and on the incidence and frequency of IL-2 dose reduction due to IL-2 induced toxicity.

OUTLINE: This is a dose escalation study of Biomed 101. Patients receive oral Biomed 101 three times daily, followed by interleukin-2 IV on days 1-5 and 16-20. Cohorts of 5 patients receive escalating doses of Biomed 101 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 5 patients experience dose limiting toxicities. Patients are followed for 1 month.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: Histologically confirmed renal cell cancer No CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: At least 12 weeks Hematopoietic: WBC at least 2,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL Hepatic: No hepatic failure No encephalopathy Bilirubin no greater than 2.5 times upper limit of normal (ULN) AST or ALT no greater than 2.5 times ULN Renal: No renal dysfunction requiring dialysis for greater than 72 hours Creatinine no greater than 2.0 mg/dL Cardiovascular: No history of sustained ventricular tachycardia (greater than 5 beats) No uncontrolled cardiac rhythm disturbances No recurrent chest pain with echocardiogram changes No angina No myocardial infarction No pericardial tamponade No moderate or severe coronary artery disease (New York Heart Association class 3 or 4) Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No significant neurological dysfunction including seizure or clinical signs of other significant neurological disease No gastrointestinal bleeding requiring surgery No concurrent infection requiring antimicrobial therapy No bowel ischemia or perforation

PRIOR CONCURRENT THERAPY: At least 30 days since prior investigational drugs No other concurrent investigational drugs No intubation required for greater than 72 hours No prior enrollment in this study

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Please refer to this study by its identifier: NCT00004890

United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
National Cancer Institute (NCI)
Study Chair: Robert A. Figlin, MD, FACP Jonsson Comprehensive Cancer Center
  More Information Identifier: NCT00004890     History of Changes
Other Study ID Numbers: CDR0000067566
Study First Received: March 7, 2000
Last Updated: March 25, 2013

Keywords provided by National Cancer Institute (NCI):
stage I renal cell cancer
stage II renal cell cancer
stage III renal cell cancer
stage IV renal cell cancer
recurrent renal cell cancer
drug extravasation

Additional relevant MeSH terms:
Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents processed this record on September 25, 2017