Status:
WITHDRAWN
Lymphocytic B-Leukemia (B-CLL) w/Human IL-2 Gene Modified & Human CD40 Ligand-Expressing Autologous 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 B-LEUKEMIA
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 s...
Detailed Description
This is a phase I trial to assess the safety of depleting regulatory T (Treg) cells using 1-3 doses of an interleukin-2 immunotoxin directed to the CD25 antigen (denileukin diftitox, ONTAK) in chronic...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00224354
Start Date
September 1 2005
End Date
December 1 2009
Last Update
May 21 2012
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