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Home > "B" Clinical Trials Conditions > Brostallicin in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma  Brostallicin in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma
Brostallicin in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma
For Condition: adult soft tissue sarcoma,gastrointestinal stromal tumor
Status: No longer recruiting
Sponsor(s): EORTC Soft Tissue and Bone Sarcoma Cooperative Group ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 15 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MichaelLeahy, , Fremantle Hospital
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, , 1066 CX
Netherlands
Centre Leon Berard
Lyon, , 69008
France
Universitaets-Krankenhaus Eppendorf
Hamburg, , D-20246
Germany
St. James's University Hospital
Leeds, England, LS9 7TF
United Kingdom
Academisch Ziekenhuis Groningen
Groningen, , 9700 RB
Netherlands
Robert Roessle Klinik
Berlin, , D-13122
Germany
Royal Marsden NHS Trust - London
London, England, SW3 6JJ
United Kingdom
U.Z. Gasthuisberg
Leuven, , B-3000
Belgium
CHU de la Timone
Marseille, , 13385
France
Institut Gustave Roussy
Villejuif, , F-94805
France
Klinikum Grosshadern der Ludwig-Maximilians Universitaet Muenchen
Munich, , D-81377
Germany
Medizinische Hochschule Hannover
Hannover, , D-30625
Germany
Universitair Ziekenhuis Antwerpen
Edegem, , B-2650
Belgium
Daniel Den Hoed Cancer Center at Erasmus University Medical Center
Rotterdam, , 3008 AE
Netherlands
Leiden University Medical Center
Leiden, , 2300 RC
Netherlands
Northern Centre for Cancer Treatment at Newcastle General Hospital
Newcastle upon Tyne, England, NE4 6BE
United Kingdom
Additional Information:
Study ID Numbers: CDR0000069456; EORTC-62011
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00041249
Other Gastrointestinal Stromal Tumor Studies:
1. STI571 in Treating Patients With Recurrent or Refractory Soft Tissue Sarcoma
2. Gemcitabine, Docetaxel, and Filgrastim in Treating Patients With Recurrent or Persistent Leiomyosarcoma or Soft Tissue Sarcoma
3. Surgery With or Without Chemotherapy in Treating Patients With Soft Tissue Sarcoma
4. Bortezomib in Treating Patients With Advanced or Metastatic Sarcoma
5. Amifostine to Protect From the Side Effects of Peripheral Stem Cell Transplantation in Treating Patients With High-Risk or Relapsed Solid Tumors
Related Studies:
Other gastrointestinal stromal tumor Clinical Trials
Other England Clinical Trials
Other Newcastle upon Tyne Clinical Trials
Brostallicin in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma
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