UCSD Launches Vaccine Therapy Trial for Chronic Lymphocytic Leukemia
Published: December 17, 2007
Clinical Trial Brief
Condition:
Chronic Lymphocytic Leukemia
Drug:
Memgen-ISF35 (Active Immune Therapy)
Phase: Phase I Intranodal Trial
Enrollment Period: August 27, 2007, continuing for 12 to 18 months
Location: Moores Cancer Center at UCSD
Eligibility: See Who is Eligible?
LA JOLLA, CA, Dec. 17, 2007 - Patients with chronic lymphocytic leukemia (CLL) who have failed chemotherapy or have chosen to forego chemotherapy have an opportunity to participate in a new clinical trial for a CLL vaccine being conducted at the Moores Cancer Center at the University of California, San Diego (UCSD).
Study participants will receive Memgen's ISF35, an active immune therapy product, or vaccine. Based on the results of previous studies, ISF35 has the potential to stimulate the immune system to act against CLL cells and fight them naturally. Memgen, a biomedical company headquartered in Dallas, Texas, licensed the technology for the ISF35 molecule from UCSD and continues clinical development of the molecule.
According to the trial's principal investigator, immunotherapy expert Januario E. Castro, MD, of the Department of Medicine: "Traditionally, CLL patients do not have a lasting response to chemotherapy. Innovative immune therapies like ISF35 offer a potentially effective alternative. This trial will be the first of its kind in that patients who qualify for the clinical trial will receive a single intranodal injection of the active immune therapy product."
ISF35 is an abbreviation for Immune Stimulatory Factor 35, which is an offspring of technology discovered by Dr. Thomas J. Kipps, MD, PhD, who is a Professor in the Department of Medicine and Deputy Director for Research at the UCSD Moores Cancer Center. This technology has been patented by the University of California and licensed to Memgen for treatment of CLL and other cancers.
Dr. Kipps says, "ISF35 gene therapy represents the next generation of leukemia targeting vaccine strategies for patients with chronic lymphocytic leukemia. ISF35 is designed to activate dormant leukemia B cells and rally T cells to selectively attack blood- and tissue-based leukemia cells."
The main purpose of this clinical trial is to determine the safety and maximum tolerated dose of ISF35 in CLL patients. Recruitment will continue for 12 to 18 months, or until a maximum of 28 patients are enrolled.
Each patient in this study will receive ISF35 via direct injection into one of the enlarged lymph nodes that harbor leukemic cells. Following injection, patients will be monitored for 24 hours at the UCSD General Clinical Research Center and periodic follow-up examinations will continue for 12 months.
In addition to its potential anti-leukemic properties, ISF35 treatment has been well tolerated in clinical trials and has not been associated with significant or unexpected side effects. Mild flu-like symptoms have been reported from use of ISF35, and they typically disappear within 72 hours.
This clinical trial has been partially funded by a research grant to UCSD by the Alliance for Cancer Gene Therapy (ACGT). According to Edward Netter, founder and board president of ACGT, "We are thrilled with the progress of Dr. Kipps' project, which we feel exemplifies ACGT's mission to identify and support innovative concepts that have enormous potential for new treatments for cancer through gene therapy."
Individuals who have CLL or physicians who treat patients with CLL can learn more about the criteria for entry into this clinical trial by contacting UCSD (see below).
Contacts
University of California, San Diego
Denise Darrah, R.N. (Clinical Research Nurse)
Phone: (858) 822-5375
Fax: (858) 822-5380
E-mail: ddarrah@ucsd.edu
Who is Eligible?
To be eligible for the trial, patients must meet all of the following criteria:
-
Diagnosis of B cell CLL/SLL, including:
- Lymphocytosis of monoclonal B cells co-expressing one or more B cell marker (CD19, CD20, or CD23) and CD5 in peripheral blood or lymph node; and
- Bone marrow with 30 percent or more mononuclear cells having the CLL/SLL phenotype
- Presence of at least one single accessible and palpable lymph node (larger than 2x2 cm) in the supraclavicular, axillary, or inguinal regions.
- Intermediate or high risk poor prognosis CLL/SLL
-
Satisfy the treatment criteria as defined by the National Cancer Institute Working Group Guidelines:
- Massive or progressive splenomegaly, or
- Massive lymph nodes, nodal clusters, or progressive lymphadenopathy, or
- Grade 2 or 3 fatigue, or
- Fever of 100.5°F or greater, or night sweats for more than two weeks without documented infection; or
- Weight loss of 10 percent or greater over the preceding six months, or
- Progressive lymphocytosis with an increase of 50 percent or greater over two months or an anticipated doubling time of less than 12 months
- Age 18 years or older
-
Laboratory parameters must meet these standards:
- Hemoglobin 10 g/dL or greater (may be post-transfusion) and platelet count 50 x 103/mm3 or greater
- Total bilirubin less than 2 x ULN, and ALT and AST less than 2 x ULN
- Creatinine 2 x ULN or less
- EGOG performance status of 2 or less
- Anticipated survival of at least 3 months
- Both men and women of reproductive potential must use effective barrier contraceptive methods during the study and for one month after treatment
- Ability to understand and agree to abide by the requirements and restrictions of the study
- Negative test results for current/active HIV-1, HIV02, HTLV-1, HTLV-2, and/or hepatitis within 30 days of registration
Patients who meet any of the following criteria are NOT eligible for the study:
- Pregnant or nursing women
- Received chemotherapy or monoclonal antibody treatment within 28 days prior to entering the study
- Diagnosis of Grade 3 or 4 cardiac disease (New York Heart Association Functional Classification criteria)
- Diagnosis of severe or debilitating pulmonary disease (e.g., significant shortness of breath, COPD, dyspnea at rest)
- Participation in any investigational drug study within 28 days prior to administration of ISF35 (patients must have recovered from all acute effects associated with previously administered investigational agents)
- History of malignancy other than CLL (except adequately treated skin cancer) within five years of registration into the study
- Presence of active symptomatic fungal, viral, and/or bacterial infection, including active HIV or viral hepatitis
- Any condition that a trial investigator believes may affect safety of treatment or evaluation of any of the trial's endpoints