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Pentostatin in Treating Patients With Refractory Chronic Graft-Versus-Host Disease

Phase 2
Completed
Conditions
Graft Versus Host Disease
Interventions
Registration Number
NCT00074035
Lead Sponsor
Alliance for Clinical Trials in Oncology
Brief Summary

RATIONALE: Pentostatin may be effective in treating chronic graft-versus-host disease by stopping the immune system from rejecting donor stem cells or donor white blood cells.

PURPOSE: This phase II trial is studying how well pentostatin works in treating patients with chronic graft-versus-host disease that is refractory (not responsive) to treatment with steroids.

Detailed Description

OBJECTIVES:

Primary

* Determine the response rate in patients with refractory chronic graft-versus-host disease treated with pentostatin.

Secondary

* Determine the time to next immunosuppressive agent (i.e., the time to progression from best response) in patients treated with this drug.

* Determine the toxicity of this drug in these patients.

* Determine the infection rate in patients treated with this drug.

* Determine the pharmacokinetics of this drug in these patients.

* Determine the changes in lymphocyte populations in patients treated with this drug.

* Determine the survival of patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive pentostatin IV over 20-30 minutes on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients who achieve a complete response after 6 courses receive 4 additional courses. Patients who achieve a partial response, minor response, or stable disease after 6 courses may receive up to 6 additional courses.

Patients are followed every 4 weeks for 1 year, every 3 months for 2 years, and then annually for 5 years.

PROJECTED ACCRUAL: Approximately 37 patients will be accrued for this study.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
39
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Pentostatinpentostatintreatment of pts with refractory graft vs host disease
Primary Outcome Measures
NameTimeMethod
Response Rate3 months

Percentage of participants who had a complete or partial response defined by the Hopkins scoring system.

A complete response is defined as the disappearance of signs and symptoms of chronic GVHD in all involved systems that is sustained for at lest 4 weeks. A partial response is an improvement by 2 or more points in at least one system score, which is sustained for at least 4 weeks, with no signs of worsening in others.

Secondary Outcome Measures
NameTimeMethod
Overall Survival At 2 Years2 year

Percentage of patients who were alive at 2 years.

Grade 3 or Higher Non-hematologic Adverse EventsDuration of treatment (up to 5 years)

Number of participants experiencing a grade 3, 4 or 5 clinically significant non-hematologic adverse events, at least possibly related to treatment.

Overall Survival At 1 Year1 year

Percentage of patients who were alive at 1 year.

Trial Locations

Locations (16)

University of Illinois Cancer Center

🇺🇸

Chicago, Illinois, United States

Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital

🇺🇸

Pittsburgh, Pennsylvania, United States

Tunnell Cancer Center at Beebe Medical Center

🇺🇸

Lewes, Delaware, United States

CCOP - Christiana Care Health Services

🇺🇸

Newark, Delaware, United States

University of Chicago Cancer Research Center

🇺🇸

Chicago, Illinois, United States

Greenebaum Cancer Center at University of Maryland Medical Center

🇺🇸

Baltimore, Maryland, United States

Union Hospital Cancer Program at Union Hospital

🇺🇸

Elkton, Maryland, United States

Cancer Institute of New Jersey at Cooper - Voorhees

🇺🇸

Voorhees, New Jersey, United States

New York Weill Cornell Cancer Center at Cornell University

🇺🇸

New York, New York, United States

Wake Forest University Comprehensive Cancer Center

🇺🇸

Winston-Salem, North Carolina, United States

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

🇺🇸

Columbus, Ohio, United States

Abramson Cancer Center of the University of Pennsylvania

🇺🇸

Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center - Philadelphia

🇺🇸

Philadelphia, Pennsylvania, United States

Virginia Commonwealth University Massey Cancer Center

🇺🇸

Richmond, Virginia, United States

Duke Comprehensive Cancer Center

🇺🇸

Durham, North Carolina, United States

Mayo Clinic Cancer Center

🇺🇸

Rochester, Minnesota, United States

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