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Home > "A" Clinical Trials Conditions > Autologous Cytotoxic T-Lymphocytes in Treating Patients With Relapsed Epstein-Barr Virus-Associated Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma

Autologous Cytotoxic T-Lymphocytes in Treating Patients With Relapsed Epstein-Barr Virus-Associated Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma



Autologous Cytotoxic T-Lymphocytes in Treating Patients With Relapsed Epstein-Barr Virus-Associated Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma

For Condition: post-transplant lymphoproliferative disorder,primary central nervous system lymphoma,recurrent/refractory childhood Hodgkin's lymphoma,recurrent adult Hodgkin's lymphoma
Status: Recruiting
Sponsor(s): Baylor College of Medicine , National Cancer Institute (NCI)
Synopsis: RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Treating a person's cytotoxic Tlymphocytes in the laboratory and reinfusing them may cause a stronger immune response to kill Epstein-Barr virus-associated cancer cells. PURPOSE: Phase I trial to study the effectiveness of autologous cytotoxic T-lymphocytes in treating patients who have relapsed Epstein-Barr virus-associated Hodgkin's lymphoma or non-Hodgkin's lymphoma.
Details: OBJECTIVES: - Determine the safety of autologous LMP2A-specific cytotoxic T-lymphocytes in patients with relapsed Epstein-Barr virus-positive Hodgkin's or non-Hodgkin's lymphoma. - Determine the survival and immune function of patients treated with this regimen. - Determine the antiviral and antitumor effects of this regimen in these patients. - Obtain preliminary information on the safety of and response to an extended dosage of this regimen in these patients. OUTLINE: Peripheral blood is collected and autologous dendritic cells (DC) are generated over 7 days using sargramostim (GM-CSF) and interleukin-4 (IL-4). DC are transduced with recombinant AdLMP2A and matured with GM-CSF, TNFa, PGE-1, and IL-4 over 2 days to stimulate cytotoxic T-lymphocytes (CTL). Patients receive LMP2A-specific CTL IV over 1-10 minutes on days 0 and 14. Cohorts of 3-6 patients receive escalating doses of LMP2A-specific CTL. Patients are evaluated at 8 weeks. Patients with stable disease or a partial response may receive 6 additional doses of LMP2A-specific CTL IV over 1-10 minutes once monthly. PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of Epstein-Barr virus-positive Hodgkin's or non-Hodgkin's lymphoma - Any histological subtype, excluding diffuse small noncleaved cell and Burkitt's lymphoma - Meets criteria for 1 of the following: - Second or subsequent relapse (or first relapse if immunosuppressive chemotherapy is contraindicated) (group A) - In remission OR with minimal residual disease after autologous stem cell transplantation for Hodgkin's or non-Hodgkin's lymphoma (group B) PATIENT CHARACTERISTICS: Age - Any age Performance status - Karnofsky 60-100% Life expectancy - More than 6 weeks Hematopoietic - Hemoglobin greater than 8.0 g/dL Hepatic - Bilirubin less than 3 times normal - AST less than 5 times normal Renal - Creatinine less than 2 times normal Other - Not pregnant - Fertile patients must use effective contraception - No concurrent severe infection - HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified Other - More than 1 month since prior investigational therapy
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
HelenHeslop,  Study Chair,  Baylor College of Medicine

Baylor College of Medicine *Recruiting*
Houston,  Texas,  77030
United States
Recruiting Catherine  Bollard 832-824-4662


Additional Information:
Study ID Numbers:  CDR0000330143;  BCM-H-9936
Study Start Date: 
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00070226

Other Primary Central Nervous System Lymphoma Studies:
1. Combination Chemotherapy in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma

2. Monoclonal Antibody Therapy in Treating Patients With Refractory Anaplastic Large Cell Lymphoma or Hodgkin's Lymphoma

3. Chemotherapy Plus Radiation Therapy in Treating Patients With Refractory or Relapsed Hodgkin's Lymphoma

4. Bortezomib in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma

5. Immunotherapy Using Cyclosporine, Interferon gamma, and Interleukin-2 After High-Dose Myeloablative Chemotherapy With Autologous Stem Cell Transplantation in Treating Patients With Refractory or Relapsed Hodgkin's Lymphoma

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