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Treatment of B-CLL with Human IL-2 and CD40 Ligand and Plasmid Gene Modified Autologous Tumor Cells 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 Treatment of B-CLL with Human IL-2 and CD40 Ligand and Plasmid Gene Modified Autologous Tumor Cells conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Treatment of B-CLL with Human IL-2 and CD40 Ligand and Plasmid Gene Modified Autologous Tumor Cells Clinical research trials and Treatment of B-CLL with Human IL-2 and CD40 Ligand and Plasmid Gene Modified Autologous Tumor Cells 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 Treatment of B-CLL with Human IL-2 and CD40 Ligand and Plasmid Gene Modified Autologous Tumor Cells. Treatment of B-CLL with Human IL-2 and CD40 Ligand and Plasmid Gene Modified Autologous Tumor Cells 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 Treatment of B-CLL with Human IL-2 and CD40 Ligand and Plasmid Gene Modified Autologous Tumor Cells clinical trial. Participants oftentimes recieve the finest healthcare available for their Treatment of B-CLL with Human IL-2 and CD40 Ligand and Plasmid Gene Modified Autologous Tumor Cells 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 > "T" Clinical Trials Conditions > Treatment of B-CLL with Human IL-2 and CD40 Ligand and Plasmid Gene Modified Autologous Tumor Cells  Treatment of B-CLL with Human IL-2 and CD40 Ligand and Plasmid Gene Modified Autologous Tumor Cells
Treatment of B-CLL with Human IL-2 and CD40 Ligand and Plasmid Gene Modified Autologous Tumor Cells
For Condition: Leukemia, B-Cell, Chronic,Leukemia
Status: Recruiting
Sponsor(s): Baylor College of Medicine , The Methodist Hospital
Synopsis: This study is for patients that have chronic lymphocytic leukemia (CLL). This research study aims to determine the safety and dosage of special cells that may make the patients own immune system fight the cancer. To do this, we will put a special gene into cancer cells that have been taken from the patients body. This will be done in the laboratory. This gene will make the cells produce interleukin 2 (IL-2), which is a natural substance that may help the immune system kill cancer cells. Additionally, we will stimulate the cancer cells with another natural protein called CD40 ligand (CD40L), which experiments in animal and human cells in vitro demonstrated can help IL-2 perform better. Some of these cells will then be put back into the patient's body. Studies of cancers in animals and in cancer cells that are grown in laboratories suggest that combining substances like IL-2 and CD40L helps the body kill cancer cells. An experimental treatment similar to this has already been used in children and similar experimental treatments are being used in adults with other cancers.
Details: This is a phase I trial to assess the safety of a dose escalation of hCD40L-expressing autologous tumor cells with a fixed dose of recombinant hIL-2 gene transduced autologous leukemic blasts. All eligible patients will be treated with a minimum of three and up to six injections. There will be no use of placebo or control subjects.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Patients are eligible for administration of their vaccine if they present with B-CLL (not in Richters transformation) with (group A) or without (group B) (Inclusion of B-CLL) measurable disease. Untreated or complete remission patients will be enrolled for vaccine administration in a therapeutic (i.e., no chemotherapy) window of three months. If during these three months (necessary to complete the vaccine study), the patient presents with rapid clinical progression, he or she will be excluded from our current study and will receive treatment according to the standard institutional guidelines. IMPORTANT NOTE: vaccine production for complete remission patients can only be achieved if tumor cells have been collected BEFORE entering complete remission. - Patients must have a life expectancy of at least 10 weeks. - Patients must have ECOG performance status of 0-2 as below: 0 = up and about, no restriction, 1 = Ambulatory, no strenuous activity, 2 = Ambulatory, capable of self-care appropriate for age. Up and about > 50% of time, but unable to carry out any physical activities or attend school, 3 = Limited self-care only. Up and about < 50% of time, 4 = Disabled, no self care. Bedridden or confined to chair. - Patients must have recovered from the toxic effects of all prior chemotherapy before entering this study, and must have an absolute neutrophil count (ANC) of > / = 500/mL, absolute lymphocyte count (ALC) > / = 200/mL, hemoglobin > / = 8g/dL, and platelet count > / = 50,000/mL - Patients must not be infected at time of protocol entry, and should not be receiving antibiotics (other than prophylactic trimethoprim sulfamethoxazole). - Patients must be HIV-negative. - Patients must be willing to practice appropriate birth control methods during the study and for 3 months after the study is concluded. This includes total abstinence, oral contraceptives, an intrauterine device, contraceptive implants under the skin, contraceptive injections (Depo-Provera). Contraceptive foam with a condom is allowed. The male partner should use a condom. - Patients must not be suffering from an autoimmune disease (including active graft-versus-host disease-GvHD, refractory immune thrombocytopenia-ITP or refractory autoimmune hemolytic anemia-AIHA) and should not be receiving immunosuppressive drugs. - Patients must have adequate liver function (total bilirubin < / = 1.5mg/dl, SGOT < / = 2 times normal, normal prothrombin time). - Patients must have adequate renal function (creatinine less than 3 times normal for age or creatinine clearance > 80mg/min/1.73m2). - Patients must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side-effects. Patients will be given a copy of the consent form. - Patient must not have received treatment with other investigational agents within the last 4 weeks. Exclusion Criteria: - Richters transformation (aggressive non-Hodgkins lymphoma), - active infection, - significant autoimmune disease (including active GvHD, ITP and AIHA), - requirement for immunosuppressive drugs, - inadequate liver and/or renal function, - pregnancy or lactation, - refusal to practice birth control methods, - seropositive for HIV, - life expectancy less than 10 weeks
Total Enrollment: 21
Location and Contact Information:
Overall Study Official:
MALCOLMBRENNER, Study Chair, Baylor College of Medicine
The Methodist Hospital *Recruiting*
Houston, Texas, 77030
United States
Recruiting MALCOLM BRENNER 832-824-4663
Additional Information:
Study ID Numbers: H11967; CLIPA
Study Start Date: January 2003
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00078520
Other Leukemia Studies:
1. Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia and Diffuse Non-Hodgkin's Lymphoma
2. Amifostine Followed by High Dose Chemotherapy in Treating Patients With Hematologic Cancer or Solid Tumors
3. PS-341 in Treating Patients With Advanced Solid Tumors or Lymphoma
4. Donor Umbilical Cord Blood Transplantation in Treating Patients With Leukemia, Lymphoma, or Nonmalignant Hematologic Disorders
5. Combination Chemotherapy With or Without Biological Therapy in Treating Patients With Refractory Solid Tumor or Lymphoma
Related Studies:
Other Leukemia Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Treatment of B-CLL with Human IL-2 and CD40 Ligand and Plasmid Gene Modified Autologous Tumor Cells
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