Gene Therapy, Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma
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|ClinicalTrials.gov Identifier: NCT00003942|
Recruitment Status : Unknown
Verified August 2000 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : July 26, 2004
Last Update Posted : December 4, 2013
RATIONALE: Inserting the gene for RevM10 into a person's peripheral stem cells may improve the body's ability to fight cancer or make the cancer more sensitive to chemotherapy.
PURPOSE: Phase I/II trial to study the effectiveness of RevM10-treated stem cells plus chemotherapy and peripheral stem cell transplantation in treating patients who have HIV-related non-Hodgkin's lymphoma.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: RevM10 gene Biological: RevM10/polAS gene Procedure: in vitro-treated peripheral blood stem cell transplantation Procedure: peripheral blood stem cell transplantation||Phase 1 Phase 2|
OBJECTIVES: I. Determine the safety of infusion of RevM10 or RevM10/polAS transduced hematopoietic stem cells (HSC) in addition to high dose chemotherapy and standard peripheral blood stem cell support in patients with HIV-1 related non-Hodgkin's lymphoma. II. Determine gene marking of lymphocytes and myeloid cells in peripheral blood, bone marrow, and/or lymph nodes after infusion of RevM10-HSC or RevM10/polAS-HSC in these patients. III. Determine the antiretroviral effect of this treatment in these patients.
OUTLINE: This is a multicenter study. Patients receive mobilization therapy and undergo leukapheresis according to a standard protocol. High dose chemotherapy is administered on days -7 to -1, also according to a standard protocol. On day 0, autologous hematopoietic stem cells transduced with genes RevM10 or RevM10/polAS are infused. Unmodified autologous peripheral blood stem cells are reinfused on day 1. Patients are followed daily for 2 weeks, weekly for 2 weeks, monthly for 1 year, then annually thereafter.
PROJECTED ACCRUAL: Approximately 15 patients will be accrued for this study within 14 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Official Title:||A Phase I/II Study of the Safety and Feasibility of REVM10 or REVM10/ANTISENSE POL 1 Transduced Hematopoietic Stem Cells (HSC) in HIV-1 Related Non-Hodgkin's Lymphoma Patients Already Being Treated With High Dose Chemotherapy and Peripheral Blood Stem Cell Support|
|Study Start Date :||November 1998|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003942
|United States, Alabama|
|University of Alabama Comprehensive Cancer Center|
|Birmingham, Alabama, United States, 35294|
|United States, California|
|Cedars-Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|Jonsson Comprehensive Cancer Center, UCLA|
|Los Angeles, California, United States, 90095-1781|
|Division of Oncology|
|Palo Alto, California, United States, 94304|
|United States, Massachusetts|
|Massachusetts General Hospital Cancer Center|
|Boston, Massachusetts, United States, 02114|
|United States, Nebraska|
|University of Nebraska Medical Center|
|Omaha, Nebraska, United States, 68198-3330|
|Study Chair:||Tyler Martin, MD||Systemix|