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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2007

Interventions

  • 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).

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary 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 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ohio State University Comprehensive Cancer Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Craig Hofmeister, Principal Investigator – Ohio State University Comprehensive Cancer Center
  • Overall Official(s)
    • Craig Hofmeister, MD, Principal Investigator, Ohio State University

Citations Reporting on Results

Poi MJ, Hofmeister CC, Johnston JS, Edwards RB, Jansak BS, Lucas DM, Farag SS, Dalton JT, Devine SM, Grever MR, Phelps MA. Standard pentostatin dose reductions in renal insufficiency are not adequate: selected patients with steroid-refractory acute graft-versus-host disease. Clin Pharmacokinet. 2013 Aug;52(8):705-12. doi: 10.1007/s40262-013-0064-7.

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