Brostallicin in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy And Safety Study Of Brostallicin In Patients With Locally Advanced Or Metastatic Soft Tissue Sarcoma Failing One Prior Chemotherapy Treatment

Conditions
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Sarcoma, Gastrointestinal Stromal Tumor

Intervention / Treatment
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* Drug: brostallicin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: brostallicin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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