Phase II Trial of Pentostatin in Steroid Refractory Acute Graft Versus Host Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Craig Hofmeister, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00201786
First received: September 12, 2005
Last updated: May 6, 2013
Last verified: May 2013
  Purpose

This study will evaluate the response rate to treatment with pentostatin in steroid-refractory acute graft versus host disease.


Condition Intervention Phase
Graft-Versus-Host Disease
Drug: Pentostatin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Pentostatin in Steroid Refractory Acute Graft Versus Host Disease

Resource links provided by NLM:


Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • Evaluate the response rate (complete and partial) to treatment with pentostatin in steroid-refractory acute GVHD. [ Time Frame: 2003-present ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Investigate the pharmacokinetics of pentostatin in patients with acute GVHD to correlate the response with area under the curve (AUC). [ Time Frame: 2003-present ] [ Designated as safety issue: Yes ]

Enrollment: 8
Study Start Date: July 2003
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Pentostatin
    Pentostatin is given at a dose of 1.5 mg/m2/day IV x 3 consecutive days. Each IV infusion of pentostatin will be administered over 20-30 minutes in 100-250 ml of D5W or NS. To prevent nephrotoxicity, patients will also receive 500 ml normal saline as pre- and post drug hydration (total 1000 ml).
    Other Name: (Nipent®, Supergen)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have biopsy proven grade II-IV acute GVHD refractory to systemic corticosteroids
  • No chronic GVHD
  • Age ≥ 18 years
  • Evidence of myeloid engraftment (ANC ≥ 0.5 x 109/l)
  • Performance status 0-3

Exclusion Criteria:

  • Patients on mechanical ventilation or who have resting O2 saturation <90% by pulse-oximetry.
  • Patients on renal dialysis or who have an estimated creatinine clearance of < 30 ml/min/1.73 m2.
  • Patients with documented clinical infection (progressive symptoms despite antibiotics or continued fever) cannot be enrolled on study until infection is controlled.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00201786

Locations
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Principal Investigator: Craig Hofmeister, MD Ohio State University
  More Information

Additional Information:
Publications:
Responsible Party: Craig Hofmeister, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00201786     History of Changes
Other Study ID Numbers: OSU-0301
Study First Received: September 12, 2005
Last Updated: May 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University Comprehensive Cancer Center:
Corticosteroids

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Pentostatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Adenosine Deaminase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 26, 2014