Emergency Access to C.V. pp65 / IE-1 Specific Cytotoxic T Lymphocytes for Recipients of Allogeneic Stem Cell Transplants With Persistant or Therapy Refractory Infections
2 Years
N/A
Both
Cancer
Trial Information
Emergency Access to C.V. pp65 / IE-1 Specific Cytotoxic T Lymphocytes for Recipients of Allogeneic Stem Cell Transplants With Persistant or Therapy Refractory Infections
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
transplantation.
Secondary
- To characterize CMV pp65- and IE-1-specific immune responses in terms of cytotoxicity
and cytokine production pre-infusion and then periodically thereafter.
- To characterize the levels of CMV DNA in recipients of CMV pp65- and IE-1-specific CTL
and observe whether the CTL infusion has any impact on level of virus.
- To determine the feasibility of CMV CTL culture from CMV-seronegative donors who have
received a CMV vaccine.
OUTLINE: This is a multicenter study.
Patients receive allogeneic cytomegalovirus (CMV) pp65- and IE-1-specific cytotoxic T-cell
lymphocytes infusion over 5 minutes on day 1. Patients may receive up to 2 more doses at
least 2 weeks after previous dose.
Blood samples are collected and analyzed by quantitative CMV PCR, chromium-release assays
for CMV pp65- and IE-1-specific cytotoxicity, and immunophenotype for CD3, CD4, CD8, CD56,
CD19, and CD45RA/RO. Intracellular cytofluorometry is used to assess IL-2, IL-4, IL-10, and
IFN-γ production by CD4 and CD8 CMV-specific effector cells.
After completion of study therapy, patients are followed periodically for up to 1 year.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Safety
Safety Issue:
Yes
Principal Investigator
Kenneth G. Lucas, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Milton S. Hershey Medical Center
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000615167
NCT ID:
NCT00769613
Start Date:
August 2008
Completion Date:
Related Keywords:
- Cancer
- stage III adult Burkitt lymphoma
- stage III adult diffuse large cell lymphoma
- stage III adult diffuse mixed cell lymphoma
- stage III adult diffuse small cleaved cell lymphoma
- stage III adult Hodgkin lymphoma
- stage III adult immunoblastic large cell lymphoma
- stage III adult lymphoblastic lymphoma
- stage III grade 1 follicular lymphoma
- stage III grade 2 follicular lymphoma
- stage III grade 3 follicular lymphoma
- stage III mantle cell lymphoma
- stage III marginal zone lymphoma
- stage III small lymphocytic lymphoma
- stage IV adult Burkitt lymphoma
- stage IV adult diffuse large cell lymphoma
- stage IV adult diffuse mixed cell lymphoma
- stage IV adult diffuse small cleaved cell lymphoma
- stage IV adult Hodgkin lymphoma
- stage IV adult immunoblastic large cell lymphoma
- stage IV adult lymphoblastic lymphoma
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage IV grade 3 follicular lymphoma
- stage IV mantle cell lymphoma
- stage IV marginal zone lymphoma
- stage IV small lymphocytic lymphoma
- recurrent adult Burkitt lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult Hodgkin lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult lymphoblastic lymphoma
- recurrent childhood large cell lymphoma
- recurrent childhood lymphoblastic lymphoma
- recurrent childhood small noncleaved cell lymphoma
- recurrent cutaneous T-cell non-Hodgkin lymphoma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- recurrent grade 3 follicular lymphoma
- recurrent mantle cell lymphoma
- recurrent marginal zone lymphoma
- recurrent small lymphocytic lymphoma
- recurrent/refractory childhood Hodgkin lymphoma
- recurrent mycosis fungoides/Sezary syndrome
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- splenic marginal zone lymphoma
- noncontiguous stage II adult Burkitt lymphoma
- noncontiguous stage II adult diffuse large cell lymphoma
- noncontiguous stage II adult diffuse mixed cell lymphoma
- noncontiguous stage II adult diffuse small cleaved cell lymphoma
- noncontiguous stage II adult immunoblastic large cell lymphoma
- noncontiguous stage II adult lymphoblastic lymphoma
- noncontiguous stage II grade 1 follicular lymphoma
- noncontiguous stage II grade 2 follicular lymphoma
- noncontiguous stage II grade 3 follicular lymphoma
- noncontiguous stage II mantle cell lymphoma
- noncontiguous stage II marginal zone lymphoma
- noncontiguous stage II small lymphocytic lymphoma
- accelerated phase chronic myelogenous leukemia
- adult acute lymphoblastic leukemia in remission
- adult acute myeloid leukemia in remission
- adult acute myeloid leukemia with 11q23 (MLL) abnormalities
- adult acute myeloid leukemia with inv(16)(p13;q22)
- adult acute myeloid leukemia with t(15;17)(q22;q12)
- adult acute myeloid leukemia with t(16;16)(p13;q22)
- adult acute myeloid leukemia with t(8;21)(q22;q22)
- atypical chronic myeloid leukemia, BCR-ABL1 negative
- blastic phase chronic myelogenous leukemia
- childhood acute lymphoblastic leukemia in remission
- childhood acute myeloid leukemia in remission
- childhood chronic myelogenous leukemia
- chronic myelomonocytic leukemia
- chronic phase chronic myelogenous leukemia
- juvenile myelomonocytic leukemia
- recurrent adult acute lymphoblastic leukemia
- recurrent adult acute myeloid leukemia
- recurrent childhood acute lymphoblastic leukemia
- recurrent childhood acute myeloid leukemia
- refractory chronic lymphocytic leukemia
- refractory hairy cell leukemia
- relapsing chronic myelogenous leukemia
- secondary acute myeloid leukemia
- stage III chronic lymphocytic leukemia
- stage IV chronic lymphocytic leukemia
- childhood myelodysplastic syndromes
- chronic eosinophilic leukemia
- primary myelofibrosis
- chronic neutrophilic leukemia
- de novo myelodysplastic syndromes
- disseminated neuroblastoma
- myelodysplastic/myeloproliferative neoplasm, unclassifiable
- high risk metastatic gestational trophoblastic tumor
- previously treated childhood rhabdomyosarcoma
- previously treated myelodysplastic syndromes
- recurrent Wilms tumor and other childhood kidney tumors
- recurrent childhood rhabdomyosarcoma
- recurrent neuroblastoma
- recurrent ovarian epithelial cancer
- recurrent ovarian germ cell tumor
- recurrent malignant testicular germ cell tumor
- secondary myelodysplastic syndromes
- stage I multiple myeloma
- stage II multiple myeloma
- stage III multiple myeloma
- stage II ovarian epithelial cancer
- stage III ovarian epithelial cancer
- stage IV ovarian epithelial cancer
- stage III malignant testicular germ cell tumor
- stage IIIA breast cancer
- stage IIIB breast cancer
- stage IIIC breast cancer
- stage IV breast cancer
- refractory multiple myeloma
- cytomegalovirus infection
- Cytomegalovirus Infections
- Emergencies
- Lymphoma, Non-Hodgkin
- Lymphoma, Large-Cell, Immunoblastic
Name | Location |
|---|---|
| Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033-0850 |
