Phase I Study to Determine the Safety of MEN-10755 (BMS-195615) in Patients With a Solid Tumor on a Short I.V. Infusion Given Once Every 3 Weeks
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
Phase I Study to Determine the Safety of MEN-10755 (BMS-195615) in Patients With a Solid Tumor on a Short I.V. Infusion Given Once Every 3 Weeks
OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of MEN-10755 in patients with
recurrent or refractory adult solid tumors. II. Determine the qualitative and quantitative
toxic effects of MEN-10755 and study the predictability, duration, intensity, onset,
reversibility, and dose relationship of the toxic effects in these patients. III. Propose a
safe dose for phase II study. IV. Assess the pharmacokinetics of MEN-10755 at different dose
levels in these patients. V. Document any possible antitumor activity of MEN-10755.
OUTLINE: This is an open label, nonrandomized study. Patients receive MEN-10755 as a single
15 minute intravenous infusion every 3 weeks, or upon recovery from toxicity. Doses will be
escalated in decreasing rates and depending on the clinical judgement of the investigator.
The MTD is the dose at which dose limiting toxicity is observed in at least 2 of 6 patients
at a given dose level. Patients will be removed from the study if cardiac toxicity, disease
progression, or renal, cardiac or pulmonary decline is present.
PROJECTED ACCRUAL: At least 5 evaluable patients will be enrolled.
Inclusion Criteria
DISEASE CHARACTERISTICS: See General Eligibility Criteria
PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: WHO 0-2 Life Expectancy: At
least 3 months Hematopoietic: ANC at least 2,000/mm3 Platelet count at least 100,000/mm3
Hepatic: Bilirubin no greater than 1.5 mg/dL Liver function tests no greater than 2 times
upper limit of normal (ULN) (unless related to liver metastases, then no greater than 5
times ULN) Renal: Creatinine no greater than 1.4 mg/dL Creatinine clearance at least 60
mL/min Cardiovascular: LVEF greater than 50% (measured by MUGA scan) Other: Not pregnant
or nursing Effective contraceptive method must be used during study No active bacterial
infections No other nonmaliganant diseases No history of alcoholism or drug abuse No
psychosis
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy within 4 weeks of study
Concurrent use of growth factors is allowed in cases of febrile neutropenia (prophylactic
use not allowed) Chemotherapy: No prior chemotherapy within 4 weeks of study No prior
nitrosoureas, mitomycin, or high dose carboplatin within 6 weeks of study Endocrine
therapy: No concurrent corticosteroids (unless approved by clinical investigator)
Radiotherapy: No prior radiotherapy within 4 weeks of study No prior extensive
radiotherapy within 6 weeks of study Surgery: Not specified Other: No prior experimental
therapy No prior anthracyclines or anthracenediones
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Per Dombernowsky, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Copenhagen County Herlev University Hospital
Authority:
United States: Federal Government
Study ID:
EORTC-16969
NCT ID:
NCT00003028
Start Date:
April 1997
Completion Date:
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
- Neoplasms
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