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

Sponsor
Ohio State University Comprehensive Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT00201786
Collaborator
(none)
8
Enrollment
1
Location
1
Arm
120
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
8 participants
Allocation:
N/A
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
Study Start Date :
Jul 1, 2003
Actual Primary Completion Date :
Oct 1, 2007
Actual Study Completion Date :
Jul 1, 2013

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • (Nipent®, Supergen)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Evaluate the response rate (complete and partial) to treatment with pentostatin in steroid-refractory acute GVHD (graft-versus-host disease). [up to 2 years]

    Secondary Outcome Measures

    1. Investigate the pharmacokinetics of pentostatin in patients with acute GVHD to correlate the response with area under the curve (AUC). [up to 2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Craig Hofmeister, Principal Investigator, Ohio State University Comprehensive Cancer Center
    ClinicalTrials.gov Identifier:
    NCT00201786
    Other Study ID Numbers:
    • OSU-0301
    First Posted:
    Sep 20, 2005
    Last Update Posted:
    Apr 27, 2016
    Last Verified:
    Apr 1, 2016
    Keywords provided by Craig Hofmeister, Principal Investigator, Ohio State University Comprehensive Cancer Center
    Corticosteroids
    Additional relevant MeSH terms:
    Graft vs Host Disease
    Pentostatin

    Study Results

    No Results Posted as of Apr 27, 2016