Nasopharyngeal Carcinoma Clinical Trial
— MALTEDOfficial title:
Most Closely HLA-Matched Allogeneic LMP1/2-Specific Cytotoxic T Lymphocytes for Treatment of Patients With Relapsed EBV-Associated Diseases
Verified date | February 2020 |
Source | Baylor College of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Patients have a type of a lymph node cancer called lymphoma, a tumor of the nasal passages
called nasopharyngeal carcinoma (NPC), a tumor of a particular type of muscle called
leiomyosarcoma (LMS) or a condition called severe chronic active EBV (SCAEBV) syndrome. The
disease has come back, may come back or has not gone away after treatment. This voluntary
research study uses special immune system cells called LMP-specific cytotoxic T lymphocytes,
a new experimental therapy.
Some patients with these diseases show evidence of infection with the virus that causes
infectious mononucleosis (called Epstein-Barr virus, or EBV) before or at the time of their
diagnosis. EBV is found in the cancer cells of up to half of the patients with lymphomas, and
in some cases of NPC and LMS, suggesting that it may play a role in causing these diseases.
Those cancer cells (as well as some B cells in SCAEBV) that are infected by EBV are able to
hide from the body's immune system and escape destruction. We want to see if special white
blood cells, called T cells, that have been trained to kill cells infected by EBV can survive
in the blood and affect the tumor.
This treatment with specially trained T cells has had activity against these viruses when the
cells are made from patients with those diseases (or, after bone marrow transplant, from the
patient's transplant donor). However, sometimes it is not possible to grow these cells; other
times, it may take 2 to 3 months to make the cells, which may be too long when one has an
active tumor. We are therefore asking if subjects would like to participate in this study,
which tests if blood cells from a donor that is a partial match with the subject (or the
transplant donor) that have been grown in the way described above can survive in the blood
and affect the disease.
These LMP-specific CTLs are an investigational product not approved by the Food and Drug
Administration.
Status | Completed |
Enrollment | 37 |
Est. completion date | January 22, 2020 |
Est. primary completion date | March 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
INCLUSION CRITERIA: SCREENING: 1. Any patient, regardless of age or sex, with one or more of the following EBV-positive or associated disorders, regardless of the histological subtype: - Hodgkin lymphoma - Non-Hodgkin lymphoma - Lymphoproliferative disorder - Nasopharyngeal carcinoma - Leiomyosarcoma - Severe chronic active EBV infection syndrome (SCAEBV), defined as high EBV viral load in plasma or PBMC (> 4000 genomes per ug PBMC DNA) and/or biopsy tissue positive for EBV 2. Karnofsky/Lansky score 50% or more. 3. Informed consent explained to and signed by patient or parent/guardian able to give informed consent and given a copy. TREATMENT: 1. Any patient, regardless of age or sex, with one or more of the following EBV-positive or associated disorders, regardless of the histological subtype: - Hodgkin lymphoma - Non-Hodgkin lymphoma - Lymphoproliferative disorder - Nasopharyngeal carcinoma - Leiomyosarcoma - Severe chronic active EBV infection syndrome (SCAEBV), defined as high EBV viral load in plasma or PBMC (> 4000 genomes per ug PBMC DNA) and/or biopsy tissue positive for EBV 2. The disease needs to be in one of the following stages: - At diagnosis or in first relapse AND the patient is unable to receive conventional chemotherapy for his/her condition. - In second or subsequent relapse. - With residual disease after autologous, syngeneic or allogeneic HSCT. 3. Life expectancy 6 weeks or more. 4. Tumor tissue is positive for EBV. 5. Karnofsky/Lansky score 50% or more. 6. Bilirubin less than 3 times higher than the normal limits, AST less than 5 times higher than the normal limits, Hgb greater than 8.0 g/dL and serum creatinine less than 3 times higher than the normal limits. 7. Pulse oximetry of greater than 90% on room air. 8. If post allogeneic HSCT, patient must not have less than 50% donor chimerism in either peripheral blood or bone marrow. 9. Clinical status at enrollment to allow tapering of steroids to less than 0.5 mg/kg/day prednisone at time of treatment. 10. Informed consent explained to and signed by patient or parent/guardian able to give informed consent and given a copy. 11. Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 3 months after the study is concluded. The male partner should use a condom. EXCLUSION CRITERIA: SCREENING: 1. Known HIV positivity. TREATMENT: 1. Currently receiving any investigational agents or have received any tumor vaccines within previous 4 weeks. 2. Active acute grade III-IV graft-versus-host disease. 3. Severe intercurrent infection. 4. Received alemtuzumab or other anti-T-cell antibody within 28 days. 5. HIV seropositivity. 6. Pregnancy (due to unknown effects of this therapy on a fetus) or lactation. 7. Tumor in a location where enlargement could cause airway obstruction. |
Country | Name | City | State |
---|---|---|---|
United States | Houston Methodist Hospital | Houston | Texas |
United States | Texas Children's Hospital | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Baylor College of Medicine | Center for Cell and Gene Therapy, Baylor College of Medicine, The Methodist Hospital System |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patients with dose limiting toxicities after T-cell infusions | To determine the safety of intravenous injections of third-party, partially HLA- matched, allogeneic Epstein Barr Virus (EBV)-specific cytotoxic T-lymphocytes (CTL) in patients with severe chronic active EBV (SCAEBV) infection or EBV-associated Hodgkin or non-Hodgkin lymphomas (HL/NHL), other lymphoproliferative disorders (LPD) or other malignancies (leiomyosarcoma and nasopharyngeal carcinoma) | 6 weeks | |
Secondary | Safety and response to a repeated dosage regimen | To obtain preliminary information on the safety and response to a repeated dosage regimen. | 5 years | |
Secondary | Analysis of immune function of CTLs | To determine the survival and the immune function of third-party allogeneic EBV-specific CTL lines | 5 years | |
Secondary | Number of patients with an EBV and/or disease response to the CTLs | To assess anti-EBV and anti-tumor effects of third-party partially HLA- matched allogeneic EBV-specific CTL lines. | 6 weeks |
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