MEN-10755 in Treating Patients With Solid Tumors

Phase 1

Completed

• Conditions: Testicular Germ Cell Tumor; Unspecified Adult Solid Tumor, Protocol Specific

• Registration Number: NCT00003982
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 1997-06
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2004-05-24
• Study First Posted: 2004-05-25
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-10
• Last Update Posted: 2012-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (27)

Innsbruck Universitaetsklinik; 🇦🇹 Innsbruck, Austria

Academisch Ziekenhuis der Vrije Universiteit; 🇳🇱 Amsterdam, Netherlands

Rotterdam Cancer Institute; 🇳🇱 Rotterdam, Netherlands

Norwegian Radium Hospital; 🇳🇴 Oslo, Norway

Centre Leon Berard; 🇫🇷 Lyon, France

Institut Claudius Regaud; 🇫🇷 Toulouse, France

Universitair Ziekenhuis Antwerpen; 🇧🇪 Edegem, Belgium

Kantonsspital - Saint Gallen; 🇨🇭 Saint Gallen, Switzerland

Newcastle General Hospital; 🇬🇧 Newcastle Upon Tyne, England, United Kingdom

Centre Jean Perrin; 🇫🇷 Clermont-Ferrand, France

Universitaetsklinik und Strahlenklinik - Essen; 🇩🇪 Essen, Germany

Antoni van Leeuwenhoekhuis; 🇳🇱 Amsterdam, Netherlands

Academisch Ziekenhuis Groningen; 🇳🇱 Groningen, Netherlands

Kaiser Franz Josef Hospital; 🇦🇹 Vienna, Austria

Ludwig Institute for Cancer Research-Brussels Branch; 🇧🇪 Brussels, Belgium

CRLCC Nantes - Atlantique; 🇫🇷 Nantes-Saint Herblain, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Klinikum Nurnberg; 🇩🇪 Nuremberg (Nurnberg), Germany

University Hospital; 🇨🇭 Basel, Switzerland

Inselspital, Bern; 🇨🇭 Bern, Switzerland

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

U.Z. Gasthuisberg; 🇧🇪 Leuven, Belgium

Institut Jules Bordet; 🇧🇪 Brussels, Belgium

Herlev Hospital - University Hospital of Copenhagen; 🇩🇰 Herlev, Denmark

University Medical Center Nijmegen; 🇳🇱 Nijmegen, Netherlands