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Completed

NCT Number: NCT00003019

Vinblastine and Methotrexate in Treating Children With Desmoid Tumors

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.

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Key information

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Princess Margaret Hospital for Children, Perth, Western Australia, Australia

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About this study

OBJECTIVES: I. Estimate the efficacy and toxicity of vinblastine and methotrexate for newly diagnosed or recurrent desmoid tumors in children who are not good candidates for treatment with surgery or radiation therapy.

OUTLINE: Patients receive vinblastine and methotrexate 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.

PROJECTED ACCRUAL: A total of 13-25 patients will be accrued for this study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

methotrexate

Drug

Other names: MTX, amethopterin, NSC #000740

vinblastine sulfate

Drug

Other names: VBL, vincaleukoblastine, Velban, NSC #49842

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

  • Children's Cancer Group
  • National Cancer Institute (NCI)

Registry information

Official study 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

Important dates

Study start
1997
Primary completion
2003
Study completion
2006
First posted
Apr 30, 2004
Registry last updated
Jul 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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