Status:
COMPLETED
Treatment of B-Chronic Lymphocytic Leukemia (B-CLL) With Autologous CD40 Ligand and IL-2-Expressing Tumor Cells
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
The Methodist Hospital Research Institute
Center for Cell and Gene Therapy, Baylor College of Medicine
Conditions:
Chronic Lymphocytic Leukemia (CLL)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
We would like patients to be in a research study to determine the safety and effectiveness of special cells that may make their own immune system fight their cancer. To do this, we will put a special...
Detailed Description
Previously, some of the cancer cells taken from the patients body were separated in the laboratory and a specially produced human virus (adenovirus) that carries the IL-2 gene was put into the cells. ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Eligibility for blast collection:
- Patients are eligible for administration of their vaccine if they present with B-CLL (not in Richter's transformation) with measurable disease.
- Procurement consent signed and faxed to Research Coordinator
- Eligibility for Vaccine Administration (protocol entry)
- Manipulated B-CLL cells available (at least 12 injections)
- Patients are eligible for administration of their vaccine if they present with B-CLL (not in Richter's transformation) with measurable disease
- Patients must have a life expectancy of at least 10 weeks.
- Patients must have ECOG performance status of 0-2 as below:
- Grade 0: Up and about, no restriction
- Grade 1: Ambulatory, no strenuous activity
- Grade 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.
- Grade 3: Limited self-care only. Up and about \< 50% of time
- Grade 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 greater than or equal to 500/uL, absolute lymphocyte count (ALC) greater than or equal to 200/uL, hemoglobin greater than or equal to 8 g/dL and platelet count greater than or equal to 50,000/uL.
- 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 \[Registered\]). Contraceptive foam with a condom is allowed. The male partner should use a condom.
- Patients must have adequate liver function (total bilirubin less than or equal to 1.5 mg/dl, SGOT less than or equal to 3 times normal, normal prothrombin time).
- Patients must have adequate renal function (creatinine less than 3 times normal for age or creatinine clearance greater than 80 mg/min/1.73m\^2).
- 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:
- Infected at time of protocol entry, or receiving antibiotics (other than prophylactic trimethoprim sulfamethoxazole).
- HIV positive
- Pregnant or lactating
- Suffering from an autoimmune disease (including active graft-versus-host disease-GvHD, refractory immune thrombocytopenia-ITP or refractory autoimmune hemolytic anemia-AIHA)
- Receiving immunosuppressive drugs
- Patients without adequate cardiac function (congestive heart failure, significant arrhythmia)
Exclusion
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00458679
Start Date
December 1 2006
End Date
August 1 2013
Last Update
February 3 2014
Active Locations (1)
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1
The Methodist Hospital
Houston, Texas, United States, 77030