Exatecan Mesylate in Treating Patients With Ewing's Sarcoma, Primitive Neuroectodermal Tumor, or Desmoplastic Small Round Cell Tumor

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 exatecan mesylate in treating patients who have relapsed or refractory Ewing's sarcoma or peripheral primitive neuroectodermal tumor or desmoplastic small round cell tumor.

Detailed Description
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OBJECTIVES: Determine the objective response rate in patients with Ewing's sarcoma, primitive neuroectodermal tumor, or desmoplastic small round cell tumor treated with exatecan mesylate. Determine the time to tumor progression in patients treated with this drug. Determine median survival and 6- and 12-month survival of patients treated with this drug. Determine the pain response in patients treated with this drug. Determine the qualitative and quantitative toxic effects of this drug in these patients. Determine the pharmacokinetics of this drug in these patients. OUTLINE: This is an open-label, non-randomized, multicenter study. Patients are stratified according to disease (relapsed or refractory localized or metastatic Ewing's sarcoma or primitive neuroectodermal tumor vs desmoplastic small round cell tumor). Patients receive exatecan mesylate IV over 30 minutes on days 1-5. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity for a maximum of 12 courses, or 6 courses beyond maximal response (whichever is longer). Patients are followed every 3 months for 1 year after withdrawal from study. PROJECTED ACCRUAL: A total of 13-27 patients will be accrued for stratum I within 12 months. A total of 9-17 patients will be accrued for stratum II within 15 months.

Official Title
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A Phase II Study Of Intravenous DX-8951f (EXATECAN MESYLATE) Administered Daily For Five Days Every Three Weeks To Pediatric And Young Adult Patients With Ewing's Sarcoma (ES), Primitive Neuroectodermal Tumor (PNET), Or Desmoplastic Small Round Cell Tumor (DSRCT)

Conditions
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Sarcoma

Intervention / Treatment
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* Drug: exatecan mesylate


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: One of the following histologically confirmed diagnoses: Relapsed or refractory Ewing's sarcoma or primitive neuroectodermal tumor Desmoplastic small round cell tumor Measurable disease The following are not considered measurable disease: Ascites Pleural effusion Lytic bone lesions No symptomatic brain metastases PATIENT CHARACTERISTICS: Age Any age Performance status ECOG 0-2 (over 10 years of age) Lansky 60-100% (10 years of age and under) Life expectancy At least 12 weeks Hematopoietic Absolute neutrophil count at least 750/mm^3 Platelet count at least 75,000/mm^3 Hemoglobin at least 8.5 g/dL Hepatic Bilirubin no greater than 2.0 mg/dL AST or ALT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) Albumin at least 2.8 g/dL Renal Creatinine less than 1.5 times ULN Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active serious infection No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix No overt psychosis or mental disability that would preclude informed consent No other life-threatening illness within the past 6 months PRIOR CONCURRENT THERAPY: Biologic therapy At least 3 months since prior autologous bone marrow or stem cell transplantation No concurrent biologic therapy Chemotherapy Recovered from prior systemic chemotherapy Prior topoisomerase I inhibitor therapy allowed No other concurrent chemotherapy Endocrine therapy Not specified Radiotherapy More than 4 weeks since prior cranial, spinal, or whole pelvis radiotherapy More than 4 weeks since prior radiotherapy to 25% of bone marrow reserve No concurrent radiotherapy Surgery At least 4 weeks since prior major surgery and recovered No concurrent surgery Other More than 28 days since prior investigational drugs (including analgesics or antiemetics) No more than 2 prior treatment regimens for this disease No other investigational drugs during and for 28 days after study therapy No other concurrent anticancer therapy No concurrent grapefruit or grapefruit juice
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: exatecan mesylate|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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childhood desmoplastic small round cell tumor, metastatic childhood soft tissue sarcoma, nonmetastatic childhood soft tissue sarcoma, recurrent childhood soft tissue sarcoma, localized Ewing sarcoma/peripheral primitive neuroectodermal tumor, metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor, recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor