At a glance
ClinicalIndex Comparison Record- ✓Progressive, debilitating, severely disfiguring, or life-threatening plexiform neurofibroma (PN) that is not surgically resectable and for which there is no other standard medical management.
- ✓Diagnosis of Neurofibromatosis type 1 confirmed by at least one criterion beyond PN (e.g., café-au-lait spots, optic glioma, Lisch nodules, distinctive bony lesions, or affected first-degree relative).
- ✓Measurable plexiform neurofibroma by physical examination or imaging with documented progression (new lesions or size increase) within 12 months prior to study entry.
- ✓Adequate bone marrow function: ANC >1000 and platelet count >100,000.
- ✕Pregnant females.
- ✕Treatment with an investigational agent within the past 30 days.
- ✕Ongoing radiation therapy, chemotherapy, hormonal therapy directed at the tumor, or immunotherapy.
- ✕Inability to return for follow-up visits or obtain required follow-up studies.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Vinblastine/Methotrexate For Severe Progressive Plexiform Neurofibromas: A Phase II Study
In Brief
A Phase 2 clinical trial evaluating Methotrexate and Vinblastine for Neurofibromatosis Type 1 and Precancerous Condition. Completed, enrolled 23 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
Methotrexate will be given at a dose of 30mg/m2/week intramuscular (IM) or intravenous (IV) for the first 26 weeks, then every 2 weeks for the next 26 weeks or until disease progression (whichever occurs first)
Vinblastine will be given at a dose of 6mg/m2/week intravenous (IV) for for the first 26 weeks, then every 2 weeks for the next 26 weeks or until disease progression (whichever occurs first). Maximum actual dose may not exceed 10mg.