Treatment of Chronic Lymphocytic B-Leukemia With IL-2 and CD-40 Autologous Tumor Cells

Completed · Phase 1

Conditions studied: Chronic Lymphocytic B-Leukemia

In brief

This is a research study 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 patient. 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 preclinical human and animal studies suggest will help IL-2 perform better. Some of these cells will then be put back into the body. The cells are grown with normal embryonic fibroblasts. 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. The purpose of this study is to learn the side effects and the safest effective dose of these special cells on the disease

Key facts

Study ID

NCT00058786

Run by

Baylor College of Medicine

People needed

9

Starts

2002-12-01

Expected to finish

2010-03-01

Last updated by the study team

2012-05-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients are eligible for administration of their vaccine if they present with B-CLL (not in Richter's transformation) with (group A) or without (group B) 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.
• Patients must have recovered from the toxic effects of all prior chemotherapy before entering this study, and must have an absolute neutrophil count of >/= 500/uL, absolute lymphocyte count >/= 200/uL, hemoglobin >/= 8g/dL and platelet count >/= 50,000/uL.
• 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.
• 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 < 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.

You may not qualify if…

• Richter's transformation (aggressive non-Hodgkin's 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

Where it is running

• The Methodist Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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