Precancerous Condition Clinical Trial
Official title:
Vinblastine/Methotrexate For Severe Progressive Plexiform Neurofibromas: A Phase II Study
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.
OBJECTIVES:
- Determine the effect of chronic vinblastine and methotrexate on time to disease
progression in children or young adults with progressive plexiform neurofibroma
associated with neurofibromatosis type 1.
- Determine the objective response rate in patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
- Determine the quality of life of patients treated with this regimen.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01946217 -
Factors Affecting Patient Participation in AIDS Malignancy Clinical Trials Consortium Clinical Trials
|
N/A | |
| Completed |
NCT00550589 -
Cidofovir in Treating HIV-Infected Patients With High-Grade Squamous Intraepithelial Lesions of the Skin Near the Anus
|
Phase 2 | |
| Completed |
NCT00653146 -
The Effects of MBSR in Improving Immune Response to Human Papillomavirus in Patients With Cervical Dysplasia
|
N/A | |
| Terminated |
NCT00629577 -
Gene Expression Profiling of Cervical Cancer Progression in Biopsies and Tissue Samples
|
Phase 1 | |
| Completed |
NCT00103246 -
Photodynamic Therapy Using Silicon Phthalocyanine 4 in Treating Patients With Actinic Keratosis, Bowen's Disease, Skin Cancer, or Stage I or Stage II Mycosis Fungoides
|
Phase 1 | |
| Completed |
NCT00066430 -
Infrared Coagulation in Preventing Anal Cancer in Patients With HIV Who Have Anal Neoplasia
|
Phase 1 | |
| Completed |
NCT00522197 -
ACAPHA in Preventing Lung Cancer in Former Smokers With Bronchial Intraepithelial Neoplasia
|
Phase 2 | |
| Completed |
NCT00003384 -
Protein Expression as a Potential Diagnostic Biomarker of Cervical Dysplasia and/or Cancer
|
N/A | |
| Terminated |
NCT02574442 -
Pilot Study In Vivo Confocal Microscopy Probe for Cervical Precancer
|
||
| Completed |
NCT00719563 -
American Ginseng in Treating Patients With Fatigue Caused by Cancer
|
Phase 3 | |
| Terminated |
NCT00899951 -
Studying Fentanyl in Patients With Cancer
|
N/A | |
| Terminated |
NCT00611650 -
Green Tea Extract in Treating Current or Former Smokers With Bronchial Dysplasia
|
Phase 2 | |
| Completed |
NCT00873288 -
Activating Collaborative CIS Support Via Targeted Provider Mailing
|
N/A | |
| Completed |
NCT00462813 -
Diindolylmethane in Treating Patients With Abnormal Cervical Cells
|
Phase 3 | |
| Completed |
NCT00006348 -
Ondansetron in Treating Patients With Advanced Cancer and Chronic Nausea and Vomiting Not Caused by Cancer Treatment
|
Phase 3 | |
| Completed |
NCT00666731 -
Breast Cancer Registry for Participants With Breast Cancer or Characteristics of Hereditary Breast Cancer
|
||
| Recruiting |
NCT04445532 -
Hepatobiliary Tumors Tissue Samples Acquisition
|
||
| Completed |
NCT00685568 -
Celecoxib in Preventing Colorectal Cancer in Young Patients With a Genetic Predisposition for Familial Adenomatous Polyposis
|
Phase 1 | |
| Terminated |
NCT00942422 -
Green Tea Extract in Treating Patients With Monoclonal Gammopathy of Undetermined Significance and/or Smoldering Multiple Myeloma
|
Phase 2 | |
| Completed |
NCT00788164 -
Vaccine Therapy With or Without Imiquimod in Treating Patients With Grade 3 Cervical Intraepithelial Neoplasia
|
Phase 1 |