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Sponsors and Collaborators: |
Sidney Kimmel Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00258180 |
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 | Intervention | Phase |
---|---|---|
Cancer-Related Problem/Condition Unspecified Childhood Solid Tumor, Protocol Specific |
Drug: cyclophosphamide Drug: filgrastim |
Phase II |
Study Type: | Interventional |
Study Design: | Supportive Care, Open Label |
Official Title: | High-Dose Cyclophosphamide for the Treatment of Severe Autoimmune Enteropathy |
Estimated Enrollment: | 11 |
Study Start Date: | June 2005 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 1 Year to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of severe autoimmune enteropathy
Disease failed to respond after ≥ 2 months of corticosteroid therapy at a dose of ≥ 0.5 mg/kg/day or ≥ 40 mg/day for patients > 20 kg AND 1 of the following therapies:
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Endocrine therapy
Other
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting |
Baltimore, Maryland, United States, 21231-2410 | |
Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce 410-955-8804 jhcccro@jhmi.edu |
Principal Investigator: | David M. Loeb, MD, PhD | Sidney Kimmel Comprehensive Cancer Center |
Principal Investigator: | Maria Oliva-Hemker, MD | Sidney Kimmel Comprehensive Cancer Center |
Study ID Numbers: | CDR0000441133, JHOC-J0326, JHOC-03070804 |
Study First Received: | November 22, 2005 |
Last Updated: | October 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00258180 |
Health Authority: | Unspecified |
unspecified childhood solid tumor, protocol specific gastrointestinal complications diarrhea |
Diarrhea Autoimmune enteropathy Cyclophosphamide Intestinal Diseases |
Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs Myeloablative Agonists |
Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents Immunosuppressive Agents Pharmacologic Actions |