Cyclophosphamide in Treating Young Patients With Severe Autoimmune Enteropathy
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|ClinicalTrials.gov Identifier: NCT00258180|
Recruitment Status : Completed
First Posted : November 24, 2005
Results First Posted : April 16, 2019
Last Update Posted : April 16, 2019
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|
|Actual Study Start Date :||August 15, 2005|
|Actual Primary Completion Date :||February 24, 2009|
|Actual Study Completion Date :||February 24, 2009|
Experimental: severe autoimmune enteropathy
Young patients with severe autoimmune enteropathy 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
Administered IV or subcutaneously once daily beginning on day 10 and continuing for 3 days or until blood counts recover
Other Name: G-CSF
Administered IV over 1 hour on days 1-4
- Number of Participants With Treatment-free Remission at 1 Year After Study Completion [ Time Frame: 1 year ]Number of participants off therapy 1 year after study completion without relapse.
- Number of Participants Experiencing Intervention-related Adverse Events, as Defined by CTCAE at 1 Month [ Time Frame: 1 month ]
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 at Johns Hopkins|
|Principal Investigator:||Maria Oliva-Hemker, MD||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|