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Phase 2
N/A
75 Years
Not Enrolling
Both
Graft Versus Host Disease

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Trial Information


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Supportive Care

Outcome Measure:

Maximum tolerated dose of high-dose cyclophosphamide

Safety Issue:

Yes

Principal Investigator

Javier Bolanos-Meade, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

J06116 CDR0000549900

NCT ID:

NCT00492921

Start Date:

May 2007

Completion Date:

January 2013

Related Keywords:

  • Graft Versus Host Disease
  • graft versus host disease
  • Graft vs Host Disease

Name

Location

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410