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Gene Therapy in HIV-Positive Patients with Non-Hodgkin's Lymphoma Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Gene Therapy in HIV-Positive Patients with Non-Hodgkin's Lymphoma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Gene Therapy in HIV-Positive Patients with Non-Hodgkin's Lymphoma Clinical research trials and Gene Therapy in HIV-Positive Patients with Non-Hodgkin's Lymphoma medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Gene Therapy in HIV-Positive Patients with Non-Hodgkin's Lymphoma. Gene Therapy in HIV-Positive Patients with Non-Hodgkin's Lymphoma Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Gene Therapy in HIV-Positive Patients with Non-Hodgkin's Lymphoma clinical trial. Participants oftentimes recieve the finest healthcare available for their Gene Therapy in HIV-Positive Patients with Non-Hodgkin's Lymphoma condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "G" Clinical Trials Conditions > Gene Therapy in HIV-Positive Patients with Non-Hodgkin's Lymphoma  Gene Therapy in HIV-Positive Patients with Non-Hodgkin's Lymphoma
Gene Therapy in HIV-Positive Patients with Non-Hodgkin's Lymphoma
For Condition: Lymphoma, Non-Hodgkin,HIV Infections
Status: Completed
Sponsor(s): Ribozyome ,
Synopsis: The purpose of this study is to see if it is safe and effective to use gene therapy to treat non-Hodgkin's lymphoma (NHL) in HIV-positive patients. Stem cell transplantation is a procedure used to treat NHL. Stem cells are very immature cells that develop to create all of the different types of blood cells. In this study, some of your stem cells will be treated with gene therapy, meaning the cells are treated with a virus that does not cause disease. Some cells will receive a virus that contains ribozymes, enzymes that may help fight HIV. Other cells will be treated with a virus that does not contain ribozymes to see how the virus works alone. Some cells will not be treated at all. Doctors would like to see whether giving patients stem cells with ribozymes can treat NHL and stop HIV from growing at the same time.
Details: In this study, CD34+ cells (stem cells) are transduced with a retroviral vector construct that incorporates multiple ribozymes, a form of RNA with the ability to selectively inhibit gene expression, targeting different sites within the HIV virus. These transduced cells are reinfused into patients as part of a bone marrow transplant procedure for AIDS/lymphoma. Patients undergoing autologous bone marrow transplantation are entered into this study. A "neutral" retrovirus named "LN" and a retrovirus that contains two ribozyme sequences named "L-TR/Tat-neo" are introduced into the patient's PBPC. The L-TR/Tat-neo retrovirus has been shown in tissue culture experiments to inhibit the replication of HIV. The LN retrovirus serves as an internal control to examine selective advantage of the gene therapy. Patients have a bone marrow sample taken. After an additional round of chemotherapy with their referring physician, patients receive daily injections of G-CSF to aid in the collection of stem cells. Daily stem cell collections are performed. It is anticipated that three to four collections will be required, but as many as six may be necessary. To prepare for the transplantation of stem cells, patients are admitted for a 7-day series of intensive chemotherapy. Following this conditioning, the gene-modified and untreated stem cells are infused back into the patient. The collected cells are divided into three pools. One is set aside without modification, one is modified with the LN control vector, and one is modified with the L-TR/Tat-neo construct. The LN and L-TR/Tat-neo samples are pooled and given to the patient by IV infusion over about 15 minutes. The unmodified cells are then infused over 10 to 15 minutes. Patients remain in the hospital until their blood cells return to adequate levels and they are well enough to be released. Following transplantation, all patients are followed at Months 1, 3, 6, 9, 12, 18, and 24. Because of the experimental nature of gene therapy, patients are followed periodically throughout their lifetimes.
Eligibility:
Study Type: Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 18 Years/60 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria You may be eligible for this study if you: - Are 18 to 60 years old. - Have been HIV-positive at least since you were diagnosed with non-Hodgkin's lymphoma. - Have an HIV level less than or equal to 25,000 copies/ml and a CD4 count of at least 100 cells/mm3. - Are currently about to undergo bone marrow transplantation. - Have responded well to cancer treatments, including chemotherapy and previous bone marrow transplantation. - Agree to use effective barrier methods of birth control, such as condoms, during the study. - Are on anti-HIV therapy (HAART). Exclusion Criteria You will not be eligible for this study if you: - Have lymphoma affecting your nervous system. - Have had any AIDS-related opportunistic infections in the past year. - Have heart disease. - Are pregnant or breast-feeding. - Have severe diarrhea. - Have a history of cytomegalovirus (CMV) retinitis. - Have dementia or encephalopathy (an infection of the brain). - Have a history of another type of cancer (except for skin cancer) before your diagnosis of NHL. - Are allergic to etoposide or have had a toxic reaction to prior chemotherapy.
Total Enrollment: 5
Location and Contact Information:
Overall Study Official:
JohnZaia, Study Chair,
City of Hope Natl Med Ctr
Duarte, California, 91010
United States
Additional Information:
Study ID Numbers: STUDY 2;
Study Start Date:
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002221
Other Hiv Infections Studies:
1. Music Imagery for Patients Receiving Chemotherapy for Leukemia or Non-Hodgkin’s Lymphoma
2. Selective T-Cell Depletion to Reduce Graft-Versus-Host-Disease in Patients Receiving Stem Cell Transplantation to Treat Leukemia, Lymphoma or Myelodysplastic Syndromes
3. Proleukin in Combination with Rituxan in Patients with Low-Grade Non-Hodgkin's Lymphoma Who Have Previously Failed Rituxan Treatments
4. Phase II Trial of Sequential Chemotherapy and Radiotherapy for AIDS-Related Primary Central Nervous System Lymphoma
5. Tumor Lysate Pulsed-Dendritic Cell Vaccines after High-Dose Chemotherapy for Non-Hodgkin's Lymphoma
Related Studies:
Other HIV Infections Clinical Trials
Other California Clinical Trials
Other Duarte Clinical Trials
Gene Therapy in HIV-Positive Patients with Non-Hodgkin's Lymphoma
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