Status:
UNKNOWN
Emergency Use of Donor Lymphocytes in Treating Patients Who Have Undergone Donor Stem Cell Transplant and Have Cytomegalovirus Infections
Lead Sponsor:
Milton S. Hershey Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Cancer
Eligibility:
All Genders
2+ years
Phase:
PHASE1
Brief Summary
RATIONALE: White blood cells that have been treated in the laboratory may kill cells that are infected with cytomegalovirus. PURPOSE: This phase I trial is studying how well cytotoxic T cells work in...
Detailed Description
OBJECTIVES: Primary * To provide access to cytomegalovirus (CMV) pp65- and IE-1-specific cytotoxic T lymphocytes (CTL) in patients with persistent CMV infections after allogeneic stem cell transplan...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Recipient of an allogeneic stem cell transplantation
- Cytomegalovirus (CMV)-seropositive and meeting 1 of the following criteria:
- Patient has a history of CMV antigenemia for ≥ 2 weeks
- CMV DNA levels ≥ 600 copies/mcg of DNA despite antiviral therapy targeting CMV (e.g., ganciclovir or foscarnet)
- No ongoing graft-vs-host disease
- Has donor available for peripheral blood mononuclear cell collection (for cytotoxic T lymphocytes production), meeting either of the following criteria:
- CMV-seropositive donor (≥ 2 years of age)
- CMV-seronegative related donor (≥ 18 years of age) who consents to receive the CMV vaccine
- PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-3 OR Lansky PS 50-100% (for patients \< 16 years of age)
- Bilirubin \< 2.0 mg/dL
- AST and ALT \< 2.5 times normal
- Creatinine clearance ≥ 30 mL/min
- Pulse oximetry ≥ 94% on no more than 40% oxygen by face mask
- Not moribund
- No patients expected to survive ≤ 1 month after the T-cell infusion due to cardiac, pulmonary, renal, hepatic, or neurologic dysfunction
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Must be on ≤ 1 mg/kg/day of prednisone or its equivalent at the time of study CTL infusion
Exclusion
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00769613
Start Date
August 1 2008
Last Update
December 18 2013
Active Locations (1)
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1
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850