Clinical trial · Interventional
Chemotherapy in Treating Children With Recurrent or Refractory Sarcomas
A Phase II Study of Continuous 21 Day Infusion of Topotecan (NSC # 609699) in Children With Relapsed Solid Tumors
NCT00003745CI-TRIAL-00009329completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| topotecan hydrochloride | Drug | Topotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- 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.
- interventionNames
- Drug: topotecan hydrochloride
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
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 therapyReferences
Publications (2)
- RESULTHawkins DS, Bradfield S, Whitlock JA, Krailo M, Franklin J, Blaney SM, Adamson PC, Reaman G. Topotecan by 21-day continuous infusion in children with relapsed or refractory solid tumors: a Children's Oncology Group study. Pediatr Blood Cancer. 2006 Nov;47(6):790-4. doi: 10.1002/pbc.20739. PMID 16435380
- RESULTBradfield S, Hawkins DS, Whitlock J, et al.: Phase II study of 21 day continuous intravenous infusion (CIVI) topotecan for recurrent pediatric solid tumors: a Children's Oncology Group Study (COG A09713). [Abstract] J Clin Oncol 23 (Suppl 16): A-8523, 805s, 2005.