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Phase IB Open-Label Rising-Dose Study of Biomed 101 in Patients Treated With Interleukin-2 for Malignancy

Phase 1
18 Years
Not Enrolling
Drug Extravasation, Kidney Cancer

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Trial Information

Phase IB Open-Label Rising-Dose Study of Biomed 101 in Patients Treated With Interleukin-2 for Malignancy

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.

Inclusion 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Robert A. Figlin, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

December 2000

Completion Date:

December 2002

Related Keywords:

  • Drug Extravasation
  • Kidney Cancer
  • 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
  • Carcinoma, Renal Cell
  • Kidney Neoplasms



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