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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00003745




Registration number
NCT00003745
Ethics application status
Date submitted
1/11/1999
Date registered
27/01/2003
Date last updated
5/02/2013

Titles & IDs
Public title
Chemotherapy in Treating Children With Recurrent or Refractory Sarcomas
Scientific title
A Phase II Study of Continuous 21 Day Infusion of Topotecan (NSC # 609699) in Children With Relapsed Solid Tumors
Secondary ID [1] 0 0
COG-A09713
Secondary ID [2] 0 0
NCI-2012-01841
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sarcoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Sarcoma (also see 'Bone') - soft tissue
Cancer 0 0 0 0
Bone

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
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
Minimum age
No limit
Maximum age
21 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/1999
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
125
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Sydney Children's Hospital - Randwick
Recruitment hospital [2] 0 0
Children's Hospital at Westmead - Westmead
Recruitment hospital [3] 0 0
Royal Children's Hospital - Brisbane
Recruitment hospital [4] 0 0
Women's and Children's Hospital - North Adelaide
Recruitment hospital [5] 0 0
Royal Children's Hospital - Parkville
Recruitment hospital [6] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2145 - Westmead
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4029 - Brisbane
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5006 - North Adelaide
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3052 - Parkville
Recruitment postcode(s) [6] 0 0
6001 - Perth
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Funding & Sponsors
Primary sponsor type
Government body
Name
National Cancer Institute (NCI)
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00003745
Trial related presentations / publications
Hawkins 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.
Bradfield 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.
Public notes

Contacts
Principal investigator
Name 0 0
Douglas Hawkins, MD
Address 0 0
Seattle Children's Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00003745