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

This study has been completed.

Sponsors and Collaborators: Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004890
  Purpose

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
Cancer-Related Problem/Condition
Kidney Cancer
Drug: Biomed 101
Drug: aldesleukin
Procedure: Biomed 101/interleukin-2
Phase I

MedlinePlus related topics:   Cancer    Kidney Cancer   

Drug Information available for:   Aldesleukin    Interleukin-2    BioMed 101   

U.S. FDA Resources

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

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

Study Start Date:   December 2000
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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004890

Locations
United States, California
Jonsson Comprehensive Cancer Center, UCLA    
      Los Angeles, California, United States, 90095-1781

Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)

Investigators
Study Chair:     Robert A. Figlin, MD, FACP     Jonsson Comprehensive Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000067566, UCLA-9908051, BIOMED-101-CLP-01, NCI-G00-1708
First Received:   March 7, 2000
Last Updated:   October 18, 2008
ClinicalTrials.gov Identifier:   NCT00004890
Health Authority:   United States: Federal Government

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

Study placed in the following topic categories:
Urogenital Neoplasms
Renal cancer
Urologic Neoplasms
Kidney cancer
Recurrence
Carcinoma
Aldesleukin
Urologic Diseases
Interleukin-2
Kidney Neoplasms
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Urinary tract neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on December 03, 2008




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