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| Sponsor: | Pediatric Oncology Group |
|---|---|
| Collaborators: |
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
Hide Study Locations| United States, California | |
| Children's Hospital Los Angeles | |
| Los Angeles, California, United States, 90027-0700 | |
| Children's Hospital of Orange County | |
| Orange, California, United States, 92668 | |
| David Grant Medical Center | |
| Travis Air Force Base, California, United States, 94535 | |
| Jonsson Comprehensive Cancer Center, UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| Long Beach Memorial Medical Center | |
| Long Beach, California, United States, 90806 | |
| UCSF Cancer Center and Cancer Research Institute | |
| San Francisco, California, United States, 94115-0128 | |
| United States, Colorado | |
| Children's Hospital of Denver | |
| Denver, Colorado, United States, 80218 | |
| United States, District of Columbia | |
| Children's National Medical Center | |
| Washington, District of Columbia, United States, 20010-2970 | |
| United States, Illinois | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637 | |
| United States, Indiana | |
| Indiana University Cancer Center | |
| Indianapolis, Indiana, United States, 46202-5265 | |
| United States, Iowa | |
| University of Iowa Hospitals and Clinics | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Michigan | |
| CCOP - Kalamazoo | |
| Kalamazoo, Michigan, United States, 49007-3731 | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109-0752 | |
| United States, Minnesota | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| University of Minnesota Cancer Center | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Missouri | |
| Children's Mercy Hospital | |
| Kansas City, Missouri, United States, 64108 | |
| United States, Nebraska | |
| University of Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68198-3330 | |
| United States, New Jersey | |
| Cancer Institute of New Jersey | |
| New Brunswick, New Jersey, United States, 08901 | |
| United States, New York | |
| Herbert Irving Comprehensive Cancer Center | |
| New York, New York, United States, 10032 | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| NYU School of Medicine's Kaplan Comprehensive Cancer Center | |
| New York, New York, United States, 10016 | |
| United States, North Carolina | |
| Lineberger Comprehensive Cancer Center, UNC | |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| United States, North Dakota | |
| CCOP - Merit Care Hospital | |
| Fargo, North Dakota, United States, 58122 | |
| Veterans Affairs Medical Center - Fargo | |
| Fargo, North Dakota, United States, 58102 | |
| United States, Ohio | |
| Children's Hospital Medical Center - Cincinnati | |
| Cincinnati, Ohio, United States, 45229-3039 | |
| Children's Hospital of Columbus | |
| Columbus, Ohio, United States, 43205-2696 | |
| Ireland Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
| United States, Oregon | |
| Doernbecher Children's Hospital | |
| Portland, Oregon, United States, 97201-3098 | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Children's Hospital of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Tennessee | |
| Vanderbilt Cancer Center | |
| Nashville, Tennessee, United States, 37232-6838 | |
| United States, Texas | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030-4009 | |
| United States, Utah | |
| Huntsman Cancer Institute | |
| Salt Lake City, Utah, United States, 84132 | |
| United States, Washington | |
| Children's Hospital and Regional Medical Center - Seattle | |
| Seattle, Washington, United States, 98105 | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98109 | |
| United States, Wisconsin | |
| University of Wisconsin Comprehensive Cancer Center | |
| Madison, Wisconsin, United States, 53792 | |
| Australia, Western Australia | |
| Princess Margaret Hospital for Children | |
| Perth, Western Australia, Australia, 6001 | |
| Canada, British Columbia | |
| British Columbia Children's Hospital | |
| Vancouver, British Columbia, Canada, V6H 3V4 | |
| Canada, Nova Scotia | |
| IWK Grace Health Centre | |
| Halifax, Nova Scotia, Canada, B3J 3G9 | |
| 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 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 |
