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| Sponsor: | Children's Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003745 |
Purpose
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.
Eligibility| 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:
Contacts and Locations
Show 235 Study Locations| Study Chair: | Douglas Hawkins, MD | Seattle Children's Hospital |
More Information
| Study ID Numbers: | CDR0000066864, COG-A09713, CCG-A09713, CCG-09713 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003745 History of Changes |
| 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 Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Enzyme Inhibitors Pharmacologic Actions Neuroectodermal Tumors Neoplasms, Connective and Soft Tissue |
Neoplasms Therapeutic Uses Neoplasms, Germ Cell and Embryonal Sarcoma Neoplasms, Neuroepithelial Topotecan Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial |