A Phase I Extension Trial of Repeated Infusions of ISF35

Completed · Phase 1

Conditions studied: Chronic Lymphocytic Leukemia

In brief

The study is a Phase Ib extension trial that will assess the toxicity, tolerability, and safety of up to two repeated administrations of 1x10\^8, 3x10\^8, or 1x10\^9 autologous Ad-ISF35-transduced CLL B cells given intravenously to patients with CLL who tolerated ISF35 in the prior Phase I infusion trial at M.D. Anderson.

Key facts

Study ID

NCT00783588

Run by

Memgen, LLC

People needed

4

Starts

2007-05-01

Expected to finish

2008-09-01

Last updated by the study team

2008-10-31

Who can join

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

You may qualify if…

• Subjects must have been enrolled and tolerated the single dose ISF35 in MDACC Protocol 2004-0914.
• Subjects must have adequate Ad-ISF35 transduced CLL B cells to allow for at least one additional treatment.
• Women of childbearing potential (not postmenopausal for at least one year or not surgically incapable of bearing children) must agree not to become pregnant for the duration of the study. Both men and women participants must agree to use contraception for the duration of the study.
• Subjects must have Zubrod performance status of ≤ 2.
• Subjects must have adequate hematologic, renal, hepatic, and coagulation function:
• Adequate hematologic function:
• Platelet count ≥ 50,000/μl; AND
• Hemoglobin ≥ 10 g/dl (may be supported by erythropoietin or transfusion).
• Adequate renal function:
• Serum creatinine ≤ 1.5 times upper limit of normal; OR
• Measured creatinine clearance ≥ 40 mL/min/1.73 m\^2.
• Adequate hepatic function:
• Total bilirubin ≤ 2.5 times upper limit of normal; AND
• ALT ≤ 2.5 times upper limit of normal; AND
• Adequate coagulation tests:
• Prothrombin time international normalized ratio (INR) ≤ 2; AND
• Partial thromboplastin time ≤ 1.66 times upper limit of normal
• Subjects must give written informed consent for the Phase 1B extension trial.

You may not qualify if…

• Unresolved toxicity (Grade ≥ 2) from single administration of Add-ISF35 transduced autologous CLL B cells.
• Presence of more than 55% prolymphocytes.
• Chemotherapy (e.g., purine analogues, alkylating agents, or corticosteroids), antibody therapy, immunotherapy, radiation therapy, or participation in any investigational drug treatment within 4 weeks of enrollment into protocol or at any time during the study.
• Ongoing toxicity from prior anti-neoplastic therapy.
• Prior gene therapy (EXCEPT Ad-ISF35) or allogeneic stem cell transplantation.
• Untreated autoimmune hemolytic anemia or immune thrombocytopenia.
• Active infection requiring parenteral antibiotics.
• HIV/HBV/HCV seropositivity.
• Uncompensated hypothyroidism (defined as TSH greater than 4x upper limit of normal not treated with replacement hormone).

Where it is running

• University of Texas M.D. Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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