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A Phase I Study of Bryostatin and Cisplatin in Patients With Advanced Cancer

Phase 1
18 Years
Not Enrolling
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase I Study of Bryostatin and Cisplatin in Patients With Advanced Cancer

OBJECTIVES: I. Determine the dose limiting toxicity and maximum tolerated dose of
combination bryostatin 1 and cisplatin chemotherapy in patients with advanced, incurable
solid tumors.

OUTLINE: This is a dose-escalation study. The first 4 cohorts of patients receive an
escalating dose of cisplatin with a fixed dose of bryostatin 1, followed by 5 cohorts
receiving an escalating dose of bryostatin 1 and a fixed dose of cisplatin. In the first
course, cisplatin is given as a 2 hour infusion followed by a 24 hour continuous infusion of
bryostatin 1. In all subsequent courses bryostatin 1 is given first and cisplatin
afterwards. Treatment continues every 21 days in patients with stable or responding disease.
Dose escalation proceeds until the maximum tolerated dose (MTD) of the combination
chemotherapy is determined. The MTD is defined as the dose preceding that at which 2 or more
patients experience dose limiting toxicity. After the MTD is determined, an additional 10
patients are treated at this dose level. Patients are followed at 1 month.

PROJECTED ACCRUAL: Approximately 24-30 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed, incurable solid tumor that is
unresectable or has distant metastasis for which a more effective therapy does not exist
No active CNS metastasis

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 8 weeks Hematopoietic: WBC at least 3000/mm3 Absolute neutrophil count at least
1500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL
Transaminases no greater than 2.5 times normal PT and PTT no greater than 1.25 times upper
limit of normal Renal: Creatinine no greater than 1.4 mg/dL Creatinine clearance at least
60 mL/min Cardiovascular: No myocardial infarction within past 6 months No congestive
heart failure or serious arrhythmias requiring treatment Other: No greater than grade 2
neuropathy (including hearing loss) No frequent vomiting or severe anorexia No recent loss
of greater than 10% of body weight Not pregnant or nursing Fertile patients must use
effective birth control during and for at least 6 months after study No serious concurrent
medical illness that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and
recovered from toxic effects No concurrent immunotherapy Chemotherapy: At least 4 weeks
since prior chemotherapy (at least 6 weeks since prior mitomycin or nitrosoureas) and
recovered No other concurrent chemotherapy Endocrine therapy: Concurrent hormonal therapy
allowed if patient has progressive disease while receiving hormonal therapy for at least
three months Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No
concurrent radiation therapy Surgery: At least 21 days since prior major surgery Other:
Any drugs that affect hepatic or renal function must be given as a stable dose and should
not be initiated after patient enters study

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

John L. Marshall, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Lombardi Cancer Research Center


United States: Federal Government

Study ID:




Start Date:

October 1997

Completion Date:

Related Keywords:

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



Lombardi Cancer Center Washington, District of Columbia  20007