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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


Phase 1
2 Years
N/A
Open (Enrolling)
Both
Cancer

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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 CenterHershey, Pennsylvania  17033-0850