Treatment of B-Chronic Lymphocytic Leukemia (B-CLL) With Autologous CD40 Ligand and IL-2-Expressing Tumor Cells

Completed · Phase 1

Conditions studied: Chronic Lymphocytic Leukemia (CLL)

In brief

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 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 their immune system kill cancer cells. Additionally, we will stimulate the cancer cells with normal embryonic fibroblasts (cells that develop into normal connective tissues in the body) so that they will make another natural protein called CD40 ligand (CD40L). Studies of cancers in animals suggest IL-2 performs better when mixed with CD40L. Some of these cells will then be put back into the patients body with the goal that they will act like a vaccine and stimulate their immune system to attack the CLL cells. Studies of cancers in animals and in cancer cells that are grown in laboratories suggest that combining substances like IL-2 and CD40L with cancer cells help the body recognize and kill cancer cells. We have already conducted a study similar to this in patients with CLL. In that study, the subjects received about three months of injections (shots). In those subjects we saw some changes in the subject's immune system that might indicate that the modified cells were helping their immune system fight the cancer. However, in most of the subjects this change in the immune system went away after the injections were stopped. In this study we want to see if we can make the change in the immune system last longer by giving more injections over a longer period of time. We hope that this might produce a better response directed at the CLL cells. We will also be looking at the effect on cells called cancer stem cells which grow into the CLL cells we see in the blood. Specifically, this study will allow subjects to receive the injections for up to one year.

Key facts

Study ID

NCT00458679

Run by

Baylor College of Medicine

People needed

6

Starts

2006-12-01

Expected to finish

2013-08-01

Last updated by the study team

2014-02-03

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• The Methodist Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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