MEN-10755 in Treating Patients With Solid Tumors

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003982
• Other study ID #: EORTC-16970
• Secondary ID: EORTC-16970
• Status: Completed
• Phase: Phase 1
• First received: November 1, 1999
• Last updated: July 10, 2012
• Start date: June 1997

Study information

• Verified date: July 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms
• Neoplasms, Germ Cell and Embryonal
• Testicular Germ Cell Tumor
• Testicular Neoplasms
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Drug:
• sabarubicin

Locations

Country	Name	City	State
Austria	Innsbruck Universitaetsklinik	Innsbruck
Austria	Kaiser Franz Josef Hospital	Vienna
Belgium	Institut Jules Bordet	Brussels
Belgium	Ludwig Institute for Cancer Research-Brussels Branch	Brussels
Belgium	Universitair Ziekenhuis Antwerpen	Edegem
Belgium	U.Z. Gasthuisberg	Leuven
Denmark	Herlev Hospital - University Hospital of Copenhagen	Herlev
France	Centre Jean Perrin	Clermont-Ferrand
France	Centre Leon Berard	Lyon
France	CRLCC Nantes - Atlantique	Nantes-Saint Herblain
France	Institut Claudius Regaud	Toulouse
France	Institut Gustave Roussy	Villejuif
Germany	Universitaetsklinik und Strahlenklinik - Essen	Essen
Germany	Klinikum Nurnberg	Nuremberg (Nurnberg)
Netherlands	Academisch Ziekenhuis der Vrije Universiteit	Amsterdam
Netherlands	Antoni van Leeuwenhoekhuis	Amsterdam
Netherlands	Academisch Ziekenhuis Groningen	Groningen
Netherlands	University Medical Center Nijmegen	Nijmegen
Netherlands	Rotterdam Cancer Institute	Rotterdam
Norway	Norwegian Radium Hospital	Oslo
Switzerland	University Hospital	Basel
Switzerland	Inselspital, Bern	Bern
Switzerland	Kantonsspital - Saint Gallen	Saint Gallen
United Kingdom	Ninewells Hospital and Medical School	Dundee	Scotland
United Kingdom	Western General Hospital	Edinburgh	Scotland
United Kingdom	C.R.C. Beatson Laboratories	Glasgow	Scotland
United Kingdom	Newcastle General Hospital	Newcastle Upon Tyne	England

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Austria,  Belgium,  Denmark,  France,  Germany,  Netherlands,  Norway,  Switzerland,  United Kingdom,