Soblidotin in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy such as soblidotin use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of soblidotin in treating patients who have advanced or metastatic soft tissue sarcoma.

Detailed Description
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OBJECTIVES: Determine the objective tumor response rate in patients with advanced or metastatic soft tissue sarcoma with prior exposure to anthracycline-based chemotherapy when treated with soblidotin. Determine the duration of response in patients treated with this drug. Determine the time to tumor progression in patients treated with this drug. Determine the median survival time and 12-month survival rate of patients treated with this drug. Determine the quantitative and qualitative toxic effects of this drug in these patients. Determine the pharmacokinetics of this drug in these patients. OUTLINE: This is an open-label, multicenter study. Patients receive soblidotin IV over 1 hour on days 1 and 8. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for survival. PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study within 12 months.

Official Title
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A Phase II Study of Intravenous TZT-1027, Administered Weekly Times Two, Every Three Weeks, to Patients With Advanced or Metastatic Soft Tissue Sarcomas (STS) With Prior Exposure to Anthracycline-Based Chemotherapy

Conditions
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Sarcoma

Intervention / Treatment
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* Drug: soblidotin


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed soft tissue sarcoma of 1 of the following tumor types: Malignant fibrous histiocytoma Liposarcoma Rhabdomyosarcoma Synovial sarcoma Malignant paraganglioma Fibrosarcoma Leiomyosarcoma Angiosarcoma, including hemangiopericytoma Malignant peripheral nerve sheath tumor Unclassified sarcoma Miscellaneous sarcoma, including mixed mesodermal tumors of the uterus The following tumor types are not eligible: Gastrointestinal stromal tumor Chondrosarcoma Malignant mesothelioma Neuroblastoma Osteosarcoma Ewing's sarcoma Embryonal rhabdomyosarcoma Evidence of disease progression Must have received 1 prior anthracycline-based chemotherapy regimen for metastatic disease Adjuvant chemotherapy is not considered 1 prior regimen unless tumor progressed within 12 months of therapy At least 1 measurable lesion with indicator lesions outside of any prior radiation field No symptomatic brain metastases PATIENT CHARACTERISTICS: Age 15 and over Performance status ECOG 0-2 Life expectancy At least 12 weeks Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic SGOT and/or SGPT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) Bilirubin no greater than 1.5 times ULN Renal Creatinine no greater than 1.5 times ULN Cardiovascular Ejection fraction at least 40% by MUGA Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No baseline neurotoxicity grade 2 or greater No concurrent serious infection No psychiatric disorder that would preclude giving informed consent or complying with study requirements No other concurrent severe or uncontrolled medical illness that would preclude study participation No other malignancy except nonmelanoma skin cancer, carcinoma in situ of the cervix, or any other malignancy for which the patient has been in complete remission and off all therapy for at least 5 years PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent anticancer biologic therapy Chemotherapy See Disease Characteristics More than 4 weeks since prior chemotherapy and recovered No other concurrent chemotherapy Endocrine therapy Not specified Radiotherapy See Disease Characteristics Recovered from prior radiotherapy No concurrent radiotherapy Localized radiotherapy to a non-indicator lesion for pain relief allowed provided all other methods of pain control are ineffective Surgery At least 4 weeks since prior major surgery and recovered Other At least 4 weeks since prior myelosuppressive therapy At least 4 weeks since prior investigational drugs No other concurrent investigational drugs No other concurrent anticancer cytotoxic therapy

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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: soblidotin|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 leiomyosarcoma, adult malignant fibrous histiocytoma, adult liposarcoma, adult rhabdomyosarcoma, adult synovial sarcoma, adult fibrosarcoma, adult angiosarcoma, adult malignant hemangiopericytoma, stage IV adult soft tissue sarcoma, recurrent adult soft tissue sarcoma