Dose-Finding Study Using Pentostatin for Injection in the Treatment of Steroid-Refractory aGvHD

This study has been terminated.

Sponsored by:	SuperGen
Information provided by:	SuperGen
ClinicalTrials.gov Identifier:	NCT00032773

Purpose

To determine a safe and effective dose of pentostatin in steroid-refractory aGvHD and to identify the minimal effective dose of pentostatin defined as the lowest dose that produces a response in 20% or more of patients while producing treatment failure (defines as death, grade 3/4 toxicity, or progressive disease) in 40% or less of patients.

Condition	Intervention	Phase
Acute Graft Versus Host Disease	Drug: pentostatin for injection	Phase I Phase II

Drug Information available for: Pentostatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Sequentially Adaptive, Open Label, Dose-Finding, Phase I/II Trial of Pentostatin in the Treatment of Steroid-Refractory Acute Graft Versus Host Disease (aGvHD)

Further study details as provided by SuperGen:

Estimated Enrollment:

Eligibility

Ages Eligible for Study:	6 Months and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion:

Patients 6 months of age with grade 2 GVHD that is steroid-refractory
Must be engrafted with ANC 1000/mL, may still be transfusion dependent for platelets and PRBC
Time post stem cell infusion < 100 days
Written informed consent
Must have adequate renal function (creatinine clearance 40 mL/min/1.73 m2

Exclusion:

Post-transplant lymphoproliferative disease
Uncontrolled infection
Mental illness or other condition preventing full cooperation with the treatment and monitoring requirements of the study
ATG within the previous 14 days
Other immunosuppressive agents (including monoclonal antibodies) when initiated within the previous 7 days.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00032773

Locations

United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States

Sponsors and Collaborators

SuperGen

More Information

Study ID Numbers:	SGI-NIP-010, NIP-010
Study First Received:	April 2, 2002
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00032773
Health Authority:	United States: Food and Drug Administration

Keywords provided by SuperGen:

acute graft versus host disease
aGVHD
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation

cord blood transplant
pentostatin
Nipent
deoxycoformycin

Study placed in the following topic categories:

Signs and Symptoms
Pentostatin
Graft versus host disease
Graft vs Host Disease
Homologous wasting disease

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009