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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003745 |
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 topotecan in treating children who have recurrent, relapsed, or refractory sarcoma.
Condition | Intervention | Phase |
---|---|---|
Sarcoma |
Drug: topotecan hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Study of Continuous 21 Day Infusion of Topotecan (NSC # 609699) in Children With Relapsed Solid Tumors |
Study Start Date: | May 1999 |
OBJECTIVES:
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.
PROJECTED ACCRUAL: A maximum of 125 patients will be accrued for this study within 2-3 years.
Ages Eligible for Study: | up to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed malignancy that is relapsed or refractory to conventional therapy at original diagnosis including:
Brain tumors
Sarcomas
Neuroblastoma
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Neurologic:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study Chair: | Douglas Hawkins, MD | Children's Hospital and Regional Medical Center, Seattle |
Study ID Numbers: | CDR0000066864, COG-A09713, CCG-A09713, CCG-09713 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003745 |
Health Authority: | United States: Federal Government |
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 |
Neuroectodermal Tumors, Primitive Ewing's family of tumors Malignant mesenchymal tumor Osteosarcoma Osteogenic sarcoma Recurrence Soft tissue sarcomas Neuroectodermal Tumors Neoplasms, Connective and Soft Tissue |
Ewing's sarcoma Sarcoma, Ewing's Peripheral neuroectodermal tumor Sarcoma Neuroepithelioma Topotecan Neuroectodermal Tumors, Primitive, Peripheral Rhabdomyosarcoma |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Pharmacologic Actions |