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

NCT00201786 | Completed Phase 2 DMC

• 1 other identifier: OSU-0301
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Graft-Versus-Host Disease

Keywords

Corticosteroids

Outcome Measures

Primary Outcomes (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 Outcomes (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

Study Arms (1)

Pentostatin

EXPERIMENTAL

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

Interventions

Pentostatin DRUG

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).

Also known as: (Nipent®, Supergen)

Pentostatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• 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.

  PMID: 23588536 RESULT

Related Links

• Jamesline

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Pentostatin

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Coformycin; Formycins; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Craig Hofmeister, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: July 1, 2003
• Primary Completion: October 1, 2007
• Study Completion: July 1, 2013
• Last Updated: April 27, 2016

Record last verified: 2016-04

Locations

US (1)