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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00003019




Trial ID
NCT00003019
Ethics application status
Date submitted
3/08/2000
Date registered
29/04/2004
Date last updated
24/07/2014

Titles & IDs
Public title
Vinblastine and Methotrexate in Treating Children With Desmoid Tumors
Scientific title
Vinblastine and Methotrexate in Children With Desmoid Tumor (Aggressive Fibromatosis) Which is Recurrent or Not Amenable to Surgical Resection or Irradiation - A Pediatric Oncology Group Phase II Study
Secondary ID [1] 0 0
POG-9650
Secondary ID [2] 0 0
9650
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Desmoid Tumor 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - methotrexate
Treatment: Drugs - vinblastine sulfate

Experimental: Chemotherapy Treatment - Patients receive vinblastine sulfate (5 mg/m2) IV and methotrexate (30 mg/m2) IV weekly for 26 weeks, then every 2 weeks for an additional 26 weeks. Treatment continues for a maximum of 1 year in the absence of unacceptable toxicity or disease progression. Patients with a complete response receive an additional 8 doses of chemotherapy. Patients are followed every 6 months for 4 years and then annually thereafter.


Treatment: Drugs: methotrexate


Treatment: Drugs: vinblastine sulfate


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Event Free Survival - To estimate the efficacy and toxicity of vinblastine and methotrexate for desmoid tumor in children with newly diagnosed or recurrent desmoid tumor who are not good candidates for treatment with surgery or radiation therapy.
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS: Histologically proven, untreated, primary desmoid tumor
(aggressive fibromatosis) for which surgery and/or radiation therapy is not thought to be
feasible (prior attempted surgical resection allowed if gross residual disease remains) No
other fibroblastic lesions or other fibromatoses allowed Recurrent desmoid tumor not
previously treated with vinca alkaloids or methotrexate and no chemotherapy since
recurrence Measurable disease by MRI

PATIENT CHARACTERISTICS: Age: Under 19 at time of diagnosis Performance status: Not
specified Life expectancy: Not specified Hematopoietic: Hemoglobin normal for age WBC
normal for age Platelet count normal for age Hepatic: Bilirubin less than 1.5 times upper
limit of normal (ULN) for age SGOT less than 1.5 times ULN for age Renal: Creatinine less
than 1.5 times ULN for age

PRIOR CONCURRENT THERAPY: See Disease Characteristics
Minimum age
No limit
Maximum age
21 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
6001 - Perth
Recruitment outside Australia
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United States of America
State/province [1] 0 0
California
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United States of America
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Colorado
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United States of America
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District of Columbia
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Illinois
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Indiana
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Iowa
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Michigan
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Minnesota
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Missouri
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Nebraska
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New Jersey
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United States of America
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New York
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North Carolina
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North Dakota
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Ohio
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Oregon
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Pennsylvania
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Tennessee
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Texas
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Utah
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Washington
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United States of America
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Wisconsin
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Canada
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British Columbia
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Canada
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Nova Scotia

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Children's Cancer Group
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy with vinblastine and
methotrexate in treating children who have desmoid tumors that are recurrent or untreatable
with surgery or radiation therapy.
Trial website
https://clinicaltrials.gov/show/NCT00003019
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Steve Skapek, MD
Address 0 0
St. Jude Children's Research Hospital
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Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
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Address 0 0
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Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries