Brostallicin in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma
Gastrointestinal Stromal Tumor, Sarcoma
About this trial
This is an interventional treatment trial for Gastrointestinal Stromal Tumor focused on measuring adult angiosarcoma, adult fibrosarcoma, adult leiomyosarcoma, adult liposarcoma, adult neurofibrosarcoma, adult synovial sarcoma, stage III adult soft tissue sarcoma, recurrent adult soft tissue sarcoma, adult malignant fibrous histiocytoma, adult malignant hemangiopericytoma, adult rhabdomyosarcoma, gastrointestinal stromal tumor, stage IV adult soft tissue sarcoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed soft tissue sarcoma that is not amenable to surgery, radiotherapy, or combined modality therapy with curative intent Stratum I Malignant fibrous histiocytoma Liposarcoma Rhabdomyosarcoma Synovial sarcoma Malignant paraganglioma Fibrosarcoma Leiomyosarcoma Angiosarcoma including hemangiopericytoma Malignant peripheral nerve sheath tumor Unclassified sarcoma Miscellaneous sarcoma Stratum II Gastrointestinal stromal tumor Previously treated with imatinib mesylate for locally advanced or metastatic disease and demonstrated disease progression The following sarcoma types are excluded: Mixed mesodermal tumors of the uterus (and carcinosarcoma) Chondrosarcoma Malignant mesothelioma Neuroblastoma Osteosarcoma Ewing's sarcoma Embryonal rhabdomyosarcoma At least one measurable lesion Progressive disease after 1 prior anthracycline- and/or alkylating-containing chemotherapy regimen for locally advanced or metastatic disease Clinical evidence of progression within 6 weeks prior to study treatment No known or symptomatic CNS metastases PATIENT CHARACTERISTICS: Age: Over 15 Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 4,000/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.25 times upper limit of normal (ULN) SGPT and SGOT no greater than 3 times ULN Alkaline phosphatase no greater than 2.5 times ULN Renal: Creatinine no greater than 1.4 mg/dL OR Creatinine clearance greater than 65 mL/min Cardiovascular: No prior severe cardiovascular disease Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception during and for up to 6 months after study No other prior or concurrent malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix No other severe medical illness No psychosis PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic response modifiers or immunotherapy No concurrent prophylactic hematopoietic growth factors (e.g., filgrastim (G- CSF) or sargramostim (GM-CSF) Chemotherapy: See Disease Characteristics More than 4 weeks since prior chemotherapy and recovered Prior adjuvant chemotherapy as first-line treatment allowed provided disease progressed within 6 months after the completion of chemotherapy No prior ecteinascidin 743 (stratum I) No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy Radiotherapy: See Disease Characteristics Recovered from prior radiotherapy No prior radiotherapy to sole measurable lesion Concurrent palliative radiotherapy to nontarget lesions allowed at investigator's discretion Surgery: See Disease Characteristics Recovered from prior surgery Other: No other concurrent anticancer therapy (approved or investigational) No concurrent participation in any other clinical treatment study No other concurrent investigational drugs
Sites / Locations
- Universitair Ziekenhuis Antwerpen
- U.Z. Gasthuisberg
- Centre Leon Berard
- CHU de la Timone
- Institut Gustave Roussy
- Robert Roessle Klinik
- Universitaets-Krankenhaus Eppendorf
- Medizinische Hochschule Hannover
- Klinikum Grosshadern der Ludwig-Maximilians Universitaet Muenchen
- Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
- Academisch Ziekenhuis Groningen
- Leiden University Medical Center
- Daniel Den Hoed Cancer Center at Erasmus University Medical Center
- St. James's University Hospital
- Royal Marsden NHS Trust - London
- Northern Centre for Cancer Treatment at Newcastle General Hospital