High-Dose Cyclophosphamide in Treating Patients With Acute Graft-Versus-Host Disease That Did Not Respond to Steroid Therapy

This study is currently recruiting participants.

Verified by National Cancer Institute (NCI), September 2007

Sponsors and Collaborators:	Sidney Kimmel Comprehensive Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00492921

Purpose

RATIONALE: High-dose cyclophosphamide may be an effective treatment for acute graft-versus-host disease that did not respond to steroid therapy.

PURPOSE: This phase II trial is studying the side effects, best dose, and how well high-dose cyclophosphamide works in treating patients with acute graft-versus-host disease that did not respond to steroid therapy.

Condition	Intervention	Phase
Graft Versus Host Disease	Drug: cyclophosphamide Drug: filgrastim	Phase II

Drug Information available for: Cyclophosphamide Filgrastim

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care
Official Title:	High Dose Cyclophosphamide in Steroid Refractory Acute Graft-Versus-Host Disease (aGVHD)

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Maximum tolerated dose of high-dose cyclophosphamide

Estimated Enrollment:	25
Study Start Date:	May 2007
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Determine the maximum tolerated dose of high-dose cyclophosphamide in patients with steroid refractory acute graft-versus-host disease.
Determine the efficacy of this regimen at 28 days post-treatment in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive high-dose cyclophosphamide once daily for 1-4 days beginning on day 1 and filgrastim (G-CSF) subcutaneously once daily beginning on day 10 and continuing until blood counts recover.

Cohorts of 3-6 patients receive escalating doses of high-dose cyclophosphamide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

After completion of study treatment, patients are followed weekly for 4 weeks.

Eligibility

Ages Eligible for Study:	up to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed acute graft-versus-host disease (GVHD) ≥ clinical grade II, that is steroid refractory
- Steroid refractory GVHD is defined as GVHD that has progressed (increasing in grading) despite 49 hours of treatment with methylprednisolone of ≥ 2.0 mg/kg OR GVHD that has failed to improve (no change in grading stage) despite 4 days of treatment with methylprednisolone of ≥ 2.0 mg/kg
Prior allogeneic hematopoietic stem cell transplantation using either bone marrow, peripheral blood stem cells, or cord blood OR prior donor lymphocyte infusion required
Evidence of myeloid engraftment
No chronic GVHD

PATIENT CHARACTERISTICS:

ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
ANC > 500/mm³
Not pregnant or nursing
Fertile patients must use effective contraception
Must be geographically accessible
No allergy or intolerance to cyclophosphamide or mesna
No HIV positivity
No mechanical ventilation
No active bleeding (excluding gastrointestinal bleeding) or history of hemorrhagic cystitis
No other uncontrolled illness including, but not limited to, the following:
- Ongoing or active infection
- Medical condition precluding patient from stopping azoles (e.g., fluconazole, itraconazole, or voriconazole) or other adequate antifungal therapy during cyclophosphamide administration
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Psychiatric illness/social situations that would preclude compliance

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00492921

Locations

United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Recruiting
Baltimore, Maryland, United States, 21231
Contact: Javier Bolanos-Meade, MD 410-614-6398 fbolano2@jhmi.edu

Sponsors and Collaborators

Sidney Kimmel Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Javier Bolanos-Meade, MD

Sidney Kimmel Comprehensive Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000549900, JHOC-J06116, JHOC-NA_00003256
Study First Received:	June 25, 2007
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00492921
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

graft versus host disease

Study placed in the following topic categories:

Graft versus host disease
Graft vs Host Disease
Cyclophosphamide
Homologous wasting disease

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs

Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009