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Study 15 of 37 for search of: | "Neurofibromatoses" |
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Sponsored by: |
Children's Hospital of Philadelphia |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00030264 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining methotrexate with vinblastine may be effective treatment for neurofibromatosis type 1 associated with progressive plexiform neurofibromas.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have neurofibromatosis type 1 associated with progressive plexiform neurofibromas.
Condition | Intervention | Phase |
---|---|---|
Neurofibromatosis Type 1 (nf1) Precancerous/Nonmalignant Condition |
Drug: methotrexate Drug: vinblastine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Vinblastine/Methotrexate For Severe Progressive Plexiform Neurofibromas: A Phase II Study |
Estimated Enrollment: | 35 |
Study Start Date: | February 2001 |
OBJECTIVES:
OUTLINE: Patients are stratified according to tumor status (severely debilitating and/or life-threatening vs cosmetically disfiguring).
Patients receive methotrexate and vinblastine IV weekly for 26 weeks and then every 2 weeks for 26 weeks in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and then every 3 months during study participation.
Patients are followed every 3 months until disease progression.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study within approximately 3 years.
Ages Eligible for Study: | up to 25 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of progressive, debilitating, severely disfiguring, or life-threatening plexiform neurofibroma (PN) that is surgically unresectable (or surgery refused by patient) and for which there is no other standard medical management
Histologic confirmation of tumor not required in the presence of consistent clinical and radiographic findings
Measurable disease
Recurrent or progressive disease as documented by an increase in size or the presence of new lesions on MRI
Must meet at least one other diagnostic criteria for neurofibromatosis type 1 (NF1):
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
CBC normal
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Pennsylvania | |
Children's Hospital of Philadelphia | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Jean B. Belasco, MD 215-590-3129 |
Study Chair: | Jean B. Belasco, MD | Children's Hospital of Philadelphia |
Responsible Party: | Children's Hospital of Philadelphia ( Jean Bello Belasco ) |
Study ID Numbers: | CDR0000069065, CHP-686, CHP-IRB-2001-2-2339, NCI-V01-1678 |
Study First Received: | February 14, 2002 |
Last Updated: | December 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00030264 |
Health Authority: | Unspecified |
plexiform neurofibroma neurofibromatosis type 1 (NF1) |
Precancerous Conditions Vinblastine Neurodegenerative Diseases Neurofibromatosis type 1 Neurofibromatosis 1 Folic Acid Neoplastic Syndromes, Hereditary Heredodegenerative Disorders, Nervous System Genetic Diseases, Inborn Neurofibroma |
Neuromuscular Diseases Peripheral Nervous System Diseases Neurofibromatoses Methotrexate Peripheral Nervous System Neoplasms Neurofibroma, Plexiform Nerve Sheath Neoplasms Nervous System Neoplasms Neurocutaneous Syndromes |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Reproductive Control Agents Therapeutic Uses Abortifacient Agents Dermatologic Agents Nucleic Acid Synthesis Inhibitors Neoplasms by Histologic Type |
Nervous System Diseases Mitosis Modulators Enzyme Inhibitors Antimitotic Agents Abortifacient Agents, Nonsteroidal Folic Acid Antagonists Immunosuppressive Agents Pharmacologic Actions Neoplasms Tubulin Modulators Antirheumatic Agents Antineoplastic Agents, Phytogenic |