Pentostatin in Treating Patients With Refractory Chronic Graft-Versus-Host Disease
NCT ID: NCT00074035
Last Updated: 2021-11-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
39 participants
INTERVENTIONAL
2003-12-31
2014-11-01
Brief Summary
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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
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Pentostatin
treatment of pts with refractory graft vs host disease
pentostatin
4 mg/sq m IV infusion over 20-30 min q 2 weeks
Interventions
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pentostatin
4 mg/sq m IV infusion over 20-30 min q 2 weeks
Eligibility Criteria
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Inclusion Criteria
* Limited skin involvement or hepatic involvement with any one of the following:
* Liver histology showing chronic progressive hepatitis, bridging necrosis or cirrhosis
* Eye involvement (Schirmer's test with \< 5 mm wetting)
* Involvement of minor salivary glands or oral mucosa
* Involvement of any other organ
4. Patients must have failed treatment with, or experience progression after, prior corticosteroids for extensive stage chronic GvHD, as defined below.
4.1 Patients will be considered to have failed corticosteroids if they have any one of the following criteria:
* Progressive disease or less than a minor response in any organ system despite 2 weeks on corticosteroid treatment at least 1 mg/kg methylprednisolone or equivalent.
* Failure to achieve at least a minor response after at least 4 weeks of treatment with a dose of ≥ 0.5 mg/kg methylprednisolone or equivalent.
* Achievement of less than a partial response at 8 weeks of corticosteroid treatment despite use of a dose ≥ 0.5 mg/kg methylprednisolone or equivalent.
* Requirement of ≥ 0.5 mg/kg methylprednisolone or equivalent to maintain a partial response or better at 12 weeks of corticosteroid treatment.
* Requirement of \> 10 mg/kg methylprednisolone or equivalent to maintain a partial response or better at 18 weeks of corticosteroid treatment.
4.2 Patients with progression of extensive stage chronic GvHD after a prior history of treatment with at least 18 weeks of corticosteroids, now requiring the reintroduction of corticosteroids (\> 10 mg/day methylprednisolone or equivalent) or an additional agent (including photopheresis, PUVA) for treatment.
5. Patients with established chronic GvHD not improving or progressing on other immunosuppressive agents are also eligible if steroid refractoriness has been established previously.
6. Age ≥ 18 years
7. Performance Status 0-3
8. Patients on mechanical ventilation are excluded.
9. No active infection. Patients with active infection requiring antibiotic therapy are not eligible until infection is controlled.
10. No HIV infection. Patients with HIV infection are excluded because of safety concerns in this patient population.
11. Non-pregnant and non-nursing. Women and men of reproductive potential should agree to use an appropriate method of birth control throughout their participation in this study due to the teratogenic potential of the therapy utilized in this trial (although it is unlikely that successful pregnancy will occur in patients with chronic GvHD). Appropriate methods of birth control include oral contraceptives, implantable hormonal contraceptives (Norplant®), or double barrier method (diaphragm plus condom).
12. Required Initial Laboratory Values:
* Calc. Creatinine Clearance ≥ 30 mL/min/1.73 m\^2
* ANC \> 1000/μL
* Platelets \> 50,000/μL without transfusion
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Sherif S. Farag, MD, PhD
Role: STUDY_CHAIR
Ohio State University
Locations
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Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware, United States
CCOP - Christiana Care Health Services
Newark, Delaware, United States
University of Illinois Cancer Center
Chicago, Illinois, 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
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees Township, New Jersey, United States
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 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
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States
Countries
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Other Identifiers
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CDR0000341678
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB-100101
Identifier Type: -
Identifier Source: org_study_id