Chemotherapy in Treating Children With Recurrent or Refractory Sarcomas

Study Overview
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Brief Summary
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Phase II trial to study the effectiveness of topotecan in treating children who have recurrent, relapsed, or refractory sarcoma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

Detailed Description
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OBJECTIVES: I. Determine the response rate in children with recurrent or refractory brain tumors, sarcomas, or neuroblastomas treated with topotecan. (Brain tumor and neuroblastoma strata closed to accrual effective 07/02/2001) II. Assess the toxicity of this regimen in a larger group of patients treated at the currently defined maximum tolerated dose. OUTLINE: This is a multicenter study. Patients receive topotecan IV continuously on days 1-21. Treatment continues at least every 4 weeks in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months.

Official Title
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A Phase II Study of Continuous 21 Day Infusion of Topotecan (NSC # 609699) in Children With Relapsed Solid Tumors

Conditions
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Sarcoma

Intervention / Treatment
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* Drug: topotecan hydrochloride


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed malignancy that is relapsed or refractory to conventional therapy at original diagnosis including: Brain tumors Gliomas or astrocytomas Medulloblastomas or primitive neuroectodermal tumor (PNET) in CNS (Brain tumor stratum closed to accrual effective 07/02/2001) Sarcomas Soft tissue sarcoma (undifferentiated sarcoma, embryonal or alveolar rhabdomyosarcoma (RMS), or non-RMS soft tissue sarcoma) Osteosarcoma Ewing's sarcoma/peripheral PNET tumors Neuroblastoma (Neuroblastoma stratum closed to accrual effective 07/02/2001) Histology requirement waived for brain stem tumors (Brain tumor stratum closed to accrual effective 07/02/2001) Measurable disease documented by clinical, radiographic, or histologic criteria Lesions in previously irradiated fields may be used to assess tumor response if there has been evidence of subsequent tumor growth in those fields No bone marrow metastases with granulocytopenia and/or thrombocytopenia PATIENT CHARACTERISTICS: Age: 30 days to 21 years at diagnosis Performance status: ECOG 0-2 Life expectancy: More than 2 months Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Hemoglobin at least 10.0 g/dL (may receive RBC transfusions) Platelet count at least 100,000/mm3 (50,000/mm3 if post bone marrow transplantation) (transfusion independent) Hepatic: Bilirubin no greater than 1.5 times normal SGOT or SGPT less than 2.5 times normal Renal: Creatinine no greater than 1.5 times normal OR Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min Neurologic: No greater than grade 2 CNS toxicity OR Stable CNS status for brain tumors (Brain tumor stratum closed to accrual effective 07/02/2001) Seizure disorders allowed if well-controlled with anticonvulsants Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 months since prior bone marrow transplantation and recovered At least 2 weeks since prior cytokines and recovered No concurrent filgrastim (G-CSF) or other cytokines No concurrent immunomodulating agents Chemotherapy: At least 2 weeks since prior chemotherapy (4 weeks for nitrosoureas) and recovered No prior topotecan or other camptothecins No other concurrent anticancer chemotherapy Endocrine therapy: Concurrent corticosteroids for CNS tumors with increased intracranial pressure allowed (Brain tumor stratum closed to accrual effective 07/02/2001) Radiotherapy: At least 2 months since prior craniospinal radiotherapy or radiotherapy to more than 50% of the bone marrow and recovered Concurrent radiotherapy to localized painful lesions allowed provided that at least 1 measurable lesion is not irradiated Other: Recovered from any other prior therapy

Ages Eligible for Study
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Maximum Age: 21 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>Patients receive topotecan IV continuously on days 1-21. Treatment continues at least every 4 weeks in the absence of unacceptable toxicity or disease progression. | Drug: topotecan hydrochloride<br> <br> |

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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recurrent childhood rhabdomyosarcoma, recurrent osteosarcoma, embryonal childhood rhabdomyosarcoma, alveolar childhood rhabdomyosarcoma, recurrent childhood soft tissue sarcoma, extraosseous Ewing sarcoma/peripheral primitive neuroectodermal tumor, recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor