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MEN-10755 in Treating Patients With Solid Tumors
This study is ongoing, but not recruiting participants.
Study NCT00003982   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: July 23, 2008   History of Changes

November 1, 1999
July 23, 2008
June 1997
 
 
 
Complete list of historical versions of study NCT00003982 on ClinicalTrials.gov Archive Site
 
 
 
MEN-10755 in Treating Patients With Solid Tumors
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

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of MEN-10755 in treating patients who have solid tumors.

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.

Phase I
Interventional
Treatment
  • Testicular Germ Cell Tumor
  • Unspecified Adult Solid Tumor, Protocol Specific
Drug: sabarubicin
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
30
 
 

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Denmark,   France,   Germany,   Netherlands,   Norway,   Switzerland,   United Kingdom
 
NCT00003982
 
CDR0000067186, EORTC-16970
European Organization for Research and Treatment of Cancer
 
Study Chair: Emma Geertruida Elisabeth De Vries, MD, PhD University Medical Centre Groningen
National Cancer Institute (NCI)
February 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP