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| 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 |
| 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 |
| Study Start Date: | December 2000 |
| Primary Completion Date: | December 2002 (Final data collection date for primary outcome measure) |
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 |
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| United States, California | |||||
| Jonsson Comprehensive Cancer Center, UCLA | |||||
| Los Angeles, California, United States, 90095-1781 | |||||
| Jonsson Comprehensive Cancer Center |
| National Cancer Institute (NCI) |
| Study Chair: | Robert A. Figlin, MD, FACP | Jonsson Comprehensive Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
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| 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 |
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