CHRONIC LYMPHOCYTIC B-LEUKEMIA Clinical Trial
— CLONTAKOfficial title:
Treatment of Chronic Lymphocytic B-Leukemia (B-CLL) With Human IL-2 Gene Modified and Human CD40 Ligand-Expressing Autologous Tumor Cells After Depletion of Regulatory T Cells
In the laboratory, we will put a special gene into cancer cells that have been taken from
the subject. This gene will make the cells produce interleukin 2 (IL-2), which may help the
patient's immune system kill cancer cells. Also, we will use CD40 ligand (CD40L) with the
IL-2. Studies of cancers in animals and in cancer cells that are grown in laboratories have
suggested adding the CD40L helps the IL-2 work better. Some of these new cells will then be
given back to the subject as a vaccine shot.
We believe that a part of the subject's immune system (cells called T-reg cells) might try
to kill off these special cells. If the T-reg cells do that, the vaccine would not work as
well or last as long. To try to avoid this, before the special cells are put back into the
subject's body, we will give them an intravenous (IV) dose of IL-2 immunotoxin (called
denileuk diftitox or ONTAK). ONTAK should get rid of some of the T-reg cells in the
subject's body which should help the special cells work better and longer.
The purpose of this study is to learn the safety and cancer-fighting effects of using IL-2
with the vaccine.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | December 2009 |
| Est. primary completion date | December 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Pre Inclusion Eligibility Criteria: Proof of B-CLL diagnosis not in Richter's transformation Eligibility Criteria: - Manipulated B-CLL cells available (at least 6 injections) - B-CLL with measurable disease, not in Richter's transformation - Life expectancy greater than or equal to 10 weeks - ECOG 0-2 (see Section 4.3 of the full protocol for details) - Recovered from the toxic effects of all prior chemotherapy - Absolute neutrophil count (ANC) greater than or equal to 500/mL - Absolute lymphocyte count (ALC) greater than or equal to 200/mL - Hemoglobin greater than or equal to 8 g/dL - Platelet count greater than or equal to 50,000/mL - Total bilirubin less than or equal to 1.5mg/dL -SGOT less than or equal to 2 x Normal - Normal PTT -Creatinine less than 3 x Normal (age-related) or Creatinine clearance > 80mg/min/1.73m2 - Serum albumin level greater than or equal to 3 g/dl - Must not have received treatment with other investigational agents within the last 4 weeks - Practicing appropriate birth control during the study and for 3 months after the study is concluded. Exclusion Criteria: - Congestive heart failure - Significant arrythmia or history of myocardial infarction - Active CNS disease or a history of seizure - Active infection / receiving antibiotics (other than prophylactic trimethoprim sulfamethoxazole - Seropositive for HIV - Pregnancy or lactation / will not use birth control methods - Autoimmune disease (GvHD, immune thrombocytopenia-ITP or autoimmune hemolytic anemia-AIHA) - Receiving immunosuppressive drugs - Hypersensitivity to denileukin diftitox or any of its components: diphteria toxin, interleukin-2, or excipients |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Baylor College of Medicine | Center for Cell and Gene Therapy, Baylor College of Medicine, The Methodist Hospital System |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety of (Treg) cells using interleukin-2 immunotoxin directed to the CD25 antigen in(B-CLL) patients, then six (SC) injections of autologous leukemic cells modified to secrete (hIL-2) and to express (hCD40L). | 15 years | Yes | |
| Primary | To obtain preliminary data on the anti-tumor effects of this treatment regimen. | 15 years | No | |
| Secondary | determine whether MHC-restricted or unrestricted anti-tumor immune responses are induced and sustained by the combination of Treg cell depletion and SC injections of B-CLL cells, which have been modified ex vivo to secrete hIL-2 and to express hCD40L | 15 years | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00058786 -
Treatment of Chronic Lymphocytic B-Leukemia With IL-2 and CD-40 Autologous Tumor Cells
|
Phase 1 |