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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00201786
First Posted: September 20, 2005
Last Update Posted: April 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Craig Hofmeister, Ohio State University Comprehensive Cancer Center
  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: Intervention Model: Single Group Assignment
Masking: None (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 Craig Hofmeister, 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 (graft-versus-host disease). [ Time Frame: up to 2 years ]

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: up to 2 years ]

Enrollment: 8
Study Start Date: July 2003
Study Completion Date: July 2013
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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): 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
First Submitted: September 12, 2005
First Posted: September 20, 2005
Last Update Posted: April 27, 2016
Last Verified: April 2016

Keywords provided by Craig Hofmeister, Ohio State University Comprehensive Cancer Center:
Corticosteroids

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