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A Phase I Trial of Bizelesin (NSC 615291) Using a Single Bolus Infusion Given Every Twenty-eight (28) Days in Patients With Advanced Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase I Trial of Bizelesin (NSC 615291) Using a Single Bolus Infusion Given Every Twenty-eight (28) Days in Patients With Advanced Cancer


OBJECTIVES: I. Determine the maximum tolerated dose of bizelesin in patients with advanced
cancer. II. Determine the qualitative and quantitative toxic effects of this therapy in
these patients. III. Determine the pharmacokinetics of this therapy in these patients. IV.
Determine the recommended dose of this drug for phase II trials. V. Determine the antitumor
effects of this therapy in these patients.

OUTLINE: This is a dose-escalation study. Patients receive bizelesin IV on day 1. Courses
repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts
of 3-6 patients receive escalating doses of bizelesin until the maximum tolerated dose (MTD)
is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients
experience dose-limiting toxicity.

PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed malignant solid tumor for which there
are no therapeutic options that are potentially curative or have been demonstrated to
increase survival No primary or metastatic CNS malignancy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life
expectancy: At least 12 weeks Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet
count at least 100,000/mm3 Hemoglobin at least 9.0 g/dL Hepatic: Bilirubin normal SGOT no
greater than 2.5 times upper limit of normal Renal: Creatinine normal OR Creatinine
clearance at least 60 mL/min Cardiovascular: No atrial or ventricular arrhythmia requiring
medication No ischemic event within the past 6 months Other: Not pregnant or nursing
Negative pregnancy test Fertile patients must use effective contraception No active
infection No other active malignancy except curatively treated carcinoma in situ of the
cervix or basal cell skin cancer No other serious concurrent medical illness No history of
seizure disorder requiring active therapy

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks
since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered Endocrine
therapy: Not specified Radiotherapy: No prior radiotherapy to more than 10% of bone marrow
No prior electron-beam radiotherapy At least 4 weeks since other prior radiotherapy
Surgery: Prior surgery allowed Other: Recovered from prior therapy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Eric K. Rowinsky, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Texas Health Science Center at San Antonio

Authority:

United States: Federal Government

Study ID:

CDR0000065606

NCT ID:

NCT00003021

Start Date:

August 1997

Completion Date:

November 2002

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific

Name

Location

Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Cancer Therapy & Research CenterSan Antonio, Texas  78229