Brostallicin in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma
- Conditions
- Gastrointestinal Stromal TumorSarcoma
- Registration Number
- NCT00041249
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of brostallicin in treating patients who have locally advanced or metastatic soft tissue sarcoma that has not responded to one previous chemotherapy regimen.
- Detailed Description
OBJECTIVES:
* Determine the antitumor activity of brostallicin, in terms of objective response, in patients with locally advanced or metastatic soft tissue sarcoma who have failed one prior chemotherapy treatment.
* Determine the time to progression and duration of response in patients treated with this drug.
* Determine the safety and toxic effects of this drug in these patients.
* Correlate clinical outcome with whole blood glutathione level in patients treated with this drug.
OUTLINE: This is a multicenter study. Patients are stratified according to tumor (tumors other than gastrointestinal stromal tumor (GIST) vs GIST).
Patients receive brostallicin IV over 10 minutes on day 1. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year and then every 4 months for 1 year.
PROJECTED ACCRUAL: A total of 58-72 patients (40 for stratum I and 18-32 for stratum II) will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (16)
Klinikum Grosshadern der Ludwig-Maximilians Universitaet Muenchen
🇩🇪Munich, Germany
Institut Gustave Roussy
🇫🇷Villejuif, France
Universitaets-Krankenhaus Eppendorf
🇩🇪Hamburg, Germany
Centre Leon Berard
🇫🇷Lyon, France
Daniel Den Hoed Cancer Center at Erasmus University Medical Center
🇳🇱Rotterdam, Netherlands
Robert Roessle Klinik
🇩🇪Berlin, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
U.Z. Gasthuisberg
🇧🇪Leuven, Belgium
Royal Marsden NHS Trust - London
🇬🇧London, England, United Kingdom
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
🇳🇱Amsterdam, Netherlands
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
Leiden University Medical Center
🇳🇱Leiden, Netherlands
Northern Centre for Cancer Treatment at Newcastle General Hospital
🇬🇧Newcastle Upon Tyne, England, United Kingdom
St. James's University Hospital
🇬🇧Leeds, England, United Kingdom
Academisch Ziekenhuis Groningen
🇳🇱Groningen, Netherlands
CHU de la Timone
🇫🇷Marseille, France