Cyclophosphamide in Treating Young Patients With Severe Autoimmune Enteropathy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00258180|
Recruitment Status : Completed
First Posted : November 24, 2005
Last Update Posted : June 14, 2012
RATIONALE: Cyclophosphamide may help control the symptoms of autoimmune enteropathy .
PURPOSE: This phase II trial is studying how well cyclophosphamide works in treating young patients with severe autoimmune enteropathy.
|Condition or disease||Intervention/treatment||Phase|
|Diarrhea Gastrointestinal Complications Unspecified Childhood Solid Tumor, Protocol Specific||Biological: filgrastim Drug: cyclophosphamide||Phase 2|
- Determine the rate of treatment-free remission in young patients with severe autoimmune enteropathy treated with high-dose cyclophosphamide.
- Determine the toxic effects of this drug in these patients.
OUTLINE: Patients receive cyclophosphamide IV over 1 hour on days 1-4. Patients then receive filgrastim (G-CSF) IV or subcutaneously once daily beginning on day 10 and continuing for 3 days or until blood counts recover.
After completion of study treatment, patients are followed periodically for up to 1½ years.
PROJECTED ACCRUAL: A total of 7-11 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||High-Dose Cyclophosphamide for the Treatment of Severe Autoimmune Enteropathy|
|Study Start Date :||June 2005|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||January 2009|
- Treatment-free remission at 1 year after study completion
- Toxicities during study treatment
- Effect of treatment on anti-enterocyte antibody titers at 1 year after study completion
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00258180
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|Principal Investigator:||David M. Loeb, MD, PhD||Sidney Kimmel Comprehensive Cancer Center|
|Principal Investigator:||Maria Oliva-Hemker, MD||Sidney Kimmel Comprehensive Cancer Center|