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 Week for 3 Consecutive Weeks, Followed by One Week's Rest
18 Years
N/A
Both
Testicular Germ Cell Tumor, 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 Week for 3 Consecutive Weeks, Followed by One Week's Rest
OBJECTIVES: I. Determine the maximum tolerated dose of MEN-10755 in patients with solid
tumors. II. Determine the qualitative and quantitative toxic effects of this drug and study
the predictability, duration, intensity, onset, reversibility and dose relationship of the
toxic effects in this patient population. III. Propose a safe dose for phase II study. IV.
Study the pharmacokinetics of this drug at different dose levels in this patient population.
V. Document any possible antitumor activity of this drug in this patient population.
OUTLINE: This is a dose escalation study. Patients receive MEN-10755 IV over 15 minutes on
days 1, 8, and 15. Treatment continues every 4 weeks, or upon recovery of toxicity,
whichever comes later. Treatment continues for at least 2 courses in the absence of
unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating
doses of MEN-10755 until the maximum tolerated dose (MTD) is determined. The MTD is defined
as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.
Patients are followed for at least 3 weeks.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study over 12 months.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed solid tumor that is not
amenable to standard therapy Measurable or evaluable disease No brain involvement or
leptomeningeal disease
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: At
least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/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) (no greater than 5 times ULN if liver
metastases present) Renal: Creatinine no greater than 1.4 mg/dL Creatinine clearance at
least 60 mL/min Cardiovascular: LVEF at least 50% (by MUGA) Other: Not pregnant or nursing
Fertile patients must use effective contraception No active infections No other
nonmalignant disease that precludes study No history of alcoholism, drug addiction, or
psychotic disorders
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy
Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas,
mitomycin, and high dose carboplatin) No other concurrent antitumor drugs Endocrine
therapy: No concurrent corticosteroids Radiotherapy: At least 4 weeks since prior
radiotherapy (6 weeks for extensive radiotherapy) No concurrent radiotherapy Surgery: Not
specified Other: No prior anthracyclines or anthracenediones No other concurrent
investigational drugs
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Emma Geertruida Elisabeth De Vries, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
University Medical Centre Groningen
Authority:
United States: Federal Government
Study ID:
EORTC-16970
NCT ID:
NCT00003982
Start Date:
June 1997
Completion Date:
Related Keywords:
- Testicular Germ Cell Tumor
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
- testicular embryonal carcinoma and yolk sac tumor
- Neoplasms, Germ Cell and Embryonal
- Neoplasms
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