A Phase II Study of Continuous 21 Day Infusion of Topotecan (NSC # 609699) in Children With Relapsed Solid Tumors
A Phase II Study of Continuous 21 Day Infusion of Topotecan (NSC # 609699) in Children With Relapsed Solid Tumors
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.
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.
DISEASE CHARACTERISTICS:
Histologically confirmed malignancy that is relapsed or refractory to conventional therapy at original diagnosis including:
Brain tumors
Sarcomas
Neuroblastoma
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:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Neurologic:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Other:
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