Lymphocytic B-Leukemia (B-CLL) w/Human IL-2 Gene Modified & Human CD40 Ligand-Expressing Autologous Tumor Cells
CLONTAK
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
2 other identifiers
interventional
N/A
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2005
Longer than P75 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 21, 2005
CompletedFirst Posted
Study publicly available on registry
September 23, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedMay 21, 2012
May 1, 2012
4.3 years
September 21, 2005
May 18, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
To obtain preliminary data on the anti-tumor effects of this treatment regimen.
15 years
Secondary Outcomes (1)
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
Interventions
Patients will be treated with six subcutaneous injections of their IL-2-secreting and hCD40L-expressing autologous B-CLL cells, separated by one to two weeks in an immunological treatment window
subcutaneous (SC) injections of autologous leukemic cells modified ex vivo to secrete human interleukin-2 (hIL-2) and to express human CD40 ligand (hCD40L).
subcutaneous (SC) injections of autologous leukemic cells modified ex vivo to secrete human interleukin-2 (hIL-2) and to express human CD40 ligand (hCD40L).
an interleukin-2 immunotoxin directed to the CD25 antigen (denileukin diftitox, ONTAK
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
GEORGE CARRUM, MD
Baylor College of Medicine
- STUDY DIRECTOR
Malcolm K Brenner, MD
Baylor College of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 21, 2005
First Posted
September 23, 2005
Study Start
September 1, 2005
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
May 21, 2012
Record last verified: 2012-05