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Phase I Study of Bryostatin-1 (NSC 339555) and Cisplatin in Advanced Malignancies


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

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Trial Information

Phase I Study of Bryostatin-1 (NSC 339555) and Cisplatin in Advanced Malignancies


OBJECTIVES: I. Determine the maximum tolerated dose and dose limiting toxicity of bryostatin
1 in combination with cisplatin in patients with advanced malignancy. II. Determine the
recommended phase II doses of bryostatin 1 and cisplatin in both a 21 day and 14 day course,
based on toxicity, effect on protein kinase C activity, and pharmacokinetics, in this
patient population. III. Determine the pharmacokinetics of bryostatin 1 in these patients.
IV. Identify any objective tumor responses arising from treatment in these patients.

OUTLINE: This is a dose escalation study of bryostatin 1. Cohorts 1-7: Patients receive
cisplatin IV over 1 hour on day 1 of the first course. Subsequent courses repeat every 21
days with bryostatin 1 IV over 24 hours on day 1 and cisplatin IV over 1 hour on day 2 in
the absence of disease progression or unacceptable toxicity. Cohorts 8-10: Patients receive
cisplatin as in cohorts 1-7. Subsequent courses repeat every 21 days with bryostatin 1 IV
over 1 hour followed by cisplatin on day 1. Cohort 11: Patients receive bryostatin 1 and
cisplatin as in cohorts 8-10. Cohorts of 3-6 patients receive escalating doses of bryostatin
1 or cisplatin until the maximum tolerated dose (MTD) of is determined. The MTD is defined
as the dose preceding that at which 2 of 3 or 2 of 6 patients experience DLT. The
recommended phase II dose (RPTD) is defined as the dose preceding the MTD. After the RPTD is
determined for the 21 day schedule, cohorts of patients receive escalating doses of
bryostatin and constant doses of cisplatin on a 14 day schedule. The MTD14 and RPTD14 are
determined in the same manner as above. Patients are followed for 6 months.

PROJECTED ACCRUAL: A total of 36-72 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed metastatic or unresectable malignant
disease Prior brain metastases with no residual signs or symptoms or medications allowed

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-2 Life expectancy: At
least 3 months Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least
100,000/mm3 Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) AST/ALT no
greater than 2.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN Renal:
Creatinine no greater than 1.5 mg/dL Other: Not pregnant or nursing Fertile patients must
use effective contraception No concurrent condition that would preclude study No
psychological, familial, sociological, or geographical condition that might compromise
medical follow up No neuropathy greater than grade 1, including hearing loss

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 3 weeks
since prior chemotherapy (6 weeks for mitomycin or nitrosoureas)and recovered Prior
cisplatin allowed Endocrine therapy: Not specified Radiotherapy: At least 2 weeks since
prior radiotherapy Prior radiotherapy for brain metastases allowed Surgery: Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Franco M. Muggia, MD

Investigator Role:

Study Chair

Investigator Affiliation:

New York University School of Medicine

Authority:

United States: Federal Government

Study ID:

CDR0000065897

NCT ID:

NCT00003132

Start Date:

January 1998

Completion Date:

Related Keywords:

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

Name

Location

NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016