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| Sponsors and Collaborators: |
Pediatric Oncology Group National Cancer Institute (NCI) Children's Cancer Group |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003019 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Desmoid Tumor |
Drug: methotrexate Drug: vinblastine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official 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 |
| Study Start Date: | August 1997 |
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.
Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Show 39 Study Locations| Study Chair: | Steve Skapek, MD | St. Jude Children's Research Hospital |
| Study Chair: | Bruce Himelstein, MD | Children's Hospital of Philadelphia |
More Information
| Study ID Numbers: | CDR0000065601, POG-9650, CCG-P9650 |
| Study First Received: | August 3, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00003019 History of Changes |
| Health Authority: | United States: Federal Government |
|
desmoid tumor |
|
Antimetabolites Fibroma Immunologic Factors Desmoid Tumor Folate Fibromatosis Vinblastine Antimitotic Agents Folinic Acid Folic Acid Antagonists Immunosuppressive Agents |
Aggressive Fibromatosis Vitamin B9 Recurrence Folic Acid Neoplasms, Connective and Soft Tissue Fibromatosis, Aggressive Tubulin Modulators Methotrexate Antirheumatic Agents Aggression Antineoplastic Agents, Phytogenic |
|
Antimetabolites Fibroma Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Vinblastine Reproductive Control Agents Neoplasms, Connective and Soft Tissue Fibromatosis, Aggressive Therapeutic Uses Abortifacient Agents Methotrexate Dermatologic Agents |
Nucleic Acid Synthesis Inhibitors Neoplasms by Histologic Type Mitosis Modulators Enzyme Inhibitors Antimitotic Agents Abortifacient Agents, Nonsteroidal Folic Acid Antagonists Immunosuppressive Agents Pharmacologic Actions Neoplasms Tubulin Modulators Neoplasms, Connective Tissue Neoplasms, Fibrous Tissue Antirheumatic Agents Antineoplastic Agents, Phytogenic |
