Chemotherapy in Treating Children With Recurrent or Refractory Sarcomas
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Sarcoma |
Drug: topotecan hydrochloride |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Continuous 21 Day Infusion of Topotecan (NSC # 609699) in Children With Relapsed Solid Tumors |
| Enrollment: | 125 |
| Study Start Date: | May 1999 |
| Primary Completion Date: | June 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
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 |
Detailed Description:
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.
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
- 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
Contacts and Locations
Show 235 Study Locations| Study Chair: | Douglas Hawkins, MD | Seattle Children's Hospital |
More Information
Additional Information:
Publications:
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003745 History of Changes |
| Other Study ID Numbers: | NCI-2012-01841, COG-A09713, CCG-A09713, CCG-09713, CDR0000066864 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 4, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Neuroectodermal Tumors, Primitive, Peripheral Sarcoma Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
Neoplasms, Connective and Soft Tissue Topotecan Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013