- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00849524
Study of Repeat Intranodal Injection of Memgen's Cancer Vaccine, Ad-ISF35, in Subjects With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
A Phase II Study of Repeat Intranodal Injections of Adenovirus-CD 154 (Ad-ISF35) in Patients With Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma
Study Overview
Status
Intervention / Treatment
Detailed Description
This is a phase II clinical trial in which study subjects will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections.
Because this is the first time that repeat administration of Ad-ISF35 will be performed via intranodal injection, and in order to allow sufficient time to evaluate the safety and toxicity of this procedure, we will treat subjects 1 thru 3 at one month intervals and with inpatient admission for 24 hours observation. After subject three receives their second ISF35 injection we will proceed with enrollment of cohorts of four patients per month at one week intervals until study enrollment has been completed. These subjects will be treated as outpatients and will be observed for 3 hours prior to discharge.
ISF35 has already been used in Phase I clinical trials. The trials demonstrated that ISF35 treatment is well-tolerated and patients did not experience any significant or unexpected adverse events. Patients reported flu-like symptoms from ISF35, which disappeared within one to three days.
ISF35 is an abbreviation for Immune Stimulatory Factor 35, an offspring of technology discovered by Dr. Thomas J. Kipps, MD, PhD, Professor, Department of Medicine and Deputy Director for Research,UCSD Moores Cancer Center.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
La Jolla, California, United States, 92093
- University of California, San Diego Moores Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Diagnosis of B-cell CLL/SLL including:
- Lymphocytosis of monoclonal B-cells co-expressing ≥ one B-cell marker (CD19, CD20, or CD23) AND
- CD5 in peripheral blood or lymph node AND
- Bone marrow with ≥ 30% mononuclear cells having the CLL/SLL phenotype.
- Presence of at least ONE single accessible AND palpable lymph node in the cervical, supraclavicular, axillary, or inguinal regions. The size of the lymph nodes must be larger than 2x2 cm in the horizontal and perpendicular axes.
- Intermediate or High risk, poor prognosis CLL/SLL
Indication for treatment as defined by the NCI Working Group Guidelines:
- Massive (> 6 cm below the left costal margin) or progressive splenomegaly OR
- Massive lymph nodes or nodal clusters (> 10 cm in longest diameter) OR *Progressive lymphadenopathy OR
- Grade 2 or 3 fatigue OR
- Fever ≥ 100.5 degrees F OR
- Night sweats for greater than 2 weeks without documented infection OR
- Presence of weight loss ≥ 10% over the preceding 6 months OR
- Progressive lymphocytosis with an increase of ≥ 50% over a 2-month period OR
- An anticipated doubling time of less than 6 months.
- Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia.
- Autoimmune anemia and/or thrombocytopenia poorly responsive to corticosteroid therapy.
- Males and females 18 years of age and older
Laboratory parameters as specified below:
- Hematologic: Hemoglobin ≥ 10 g/dL (may be post-transfusion); platelet count ≥ 50x10^3/mm^3
- Hepatic: Total Bilirubin < 2 x ULN, and ALT and AST < 2 x ULN
- Renal: Creatinine ≤ 2 x ULN
- ECOG Performance Status ≤ 2
- Anticipated survival of at least 3 months
- For men and women of child-producing potential, use of effective barrier contraceptive methods during the study and for one month following treatment.
- Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and return for the required assessments.
- Negative test results for current/active infection with HIV-1, HIV-2, HTLV-1, HTLV-2, CMV, hepatitis A, B, C within 30 days of registration. (Antibody, antigen and nucleic acid tests acceptable, depending on institutional standards.).
- Subjects must give written informed consent to participate in this trial.
- Subjects must have received treatment for CLL with chemotherapy agents or antibodies OR if subjects are previously untreated they must state in the consent form that they are refusing to be treated with chemotherapy or antibodies.
Exclusion Criteria:
- Pregnant or nursing women.
- Treatment with chemotherapy or monoclonal antibody within 28 days prior to entering the study.
- Treatment with chemotherapy or monoclonal antibody during the time of participation in this trial.
- Grade 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification.
- Severe or debilitating pulmonary disease (dyspnea at rest, significant shortness of breath, COPD).
- Participation in any investigational drug study within 28 days prior to ISF35 administration. (Patient must have recovered from all acute effects of previously administered investigational agents)
- History of malignancy other than CLL within five years of registration, except patients with adequately treated basal, squamous cell carcinoma or localized cervical cancer.
- Active symptomatic fungal, bacterial and/or viral infection including active HIV or viral (A, B or C) hepatitis.
- Any illness or condition that in the opinion of the Investigator may affect safety of treatment or evaluation of any the study's endpoints.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Ad-ISF35
Ad-ISF35, intranodal injection, 3.3 x 10^10 ISF35 viral particles, every 2-4 weeks up to six total injections.
|
Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles.
Intranodal injections will be administered every 2-4 weeks up to six total injections.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine and Monitor Clinical and Biological Responses in Patients Treated With Repeat Intranodal Injections of Ad-ISF35.
Time Frame: 2 years (evaluation will be approx. 4 months per patient)
|
2 years (evaluation will be approx. 4 months per patient)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine the Safety of Repeat Administration of Ad-ISF35 Injected Directly Into Lymph Nodes of Patients With CLL/SLL.
Time Frame: 2 years (evaluation will be approx. 1 year per patient)
|
2 years (evaluation will be approx. 1 year per patient)
|
Determine Pharmacodynamic Parameters in Patients Treated With Repeat Intranodal Injections of Ad-ISF35.
Time Frame: 2 years (evaluation will be approx. 4 months per patient)
|
2 years (evaluation will be approx. 4 months per patient)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Januario Castro, M.D., Associate Clinical Professor in the Blood and Marrow Transplantation Division
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UCSD-101357 - prev 080497
- CLL-35-202
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Lymphocytic Leukemia
-
National Heart, Lung, and Blood Institute (NHLBI)Active, not recruitingLeukemia, Lymphocytic, Chronic, B-Cell | Chronic Lymphocytic Leukemia | Leukemia, Chronic Lymphatic | B-Cell Chronic Lymphocytic Leukemia | Leukemia, Lymphocytic, Chronic | B-Lymphocytic Leukemia, Chronic | Leukemia, Chronic Lymphocytic, B-Cell | Lymphocytic Leukemia, Chronic, B Cell | Lymphocytic Leukemia...United States
-
National Cancer Institute (NCI)CompletedB-cell Chronic Lymphocytic Leukemia | Refractory Chronic Lymphocytic Leukemia | Stage I Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic Leukemia | Stage III Chronic Lymphocytic Leukemia | Stage IV Chronic Lymphocytic LeukemiaUnited States
-
National Cancer Institute (NCI)TerminatedRefractory Chronic Lymphocytic Leukemia | Stage I Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic Leukemia | Stage III Chronic Lymphocytic Leukemia | Stage IV Chronic Lymphocytic LeukemiaUnited States
-
Mayo ClinicNational Cancer Institute (NCI)CompletedB-cell Chronic Lymphocytic Leukemia | Refractory Chronic Lymphocytic Leukemia | Stage 0 Chronic Lymphocytic Leukemia | Stage I Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic LeukemiaUnited States
-
National Cancer Institute (NCI)CompletedB-cell Chronic Lymphocytic Leukemia | Stage I Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic Leukemia | Stage III Chronic Lymphocytic Leukemia | Stage IV Chronic Lymphocytic LeukemiaUnited States
-
National Cancer Institute (NCI)TerminatedLeukemia | B-cell Chronic Lymphocytic Leukemia | Prolymphocytic Leukemia | Refractory Chronic Lymphocytic Leukemia | Stage I Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic Leukemia | Stage III Chronic Lymphocytic Leukemia | Stage IV Chronic Lymphocytic LeukemiaUnited States
-
OHSU Knight Cancer InstituteOregon Health and Science UniversityCompletedRefractory Chronic Lymphocytic Leukemia | Stage I Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic Leukemia | Stage III Chronic Lymphocytic Leukemia | Stage IV Chronic Lymphocytic LeukemiaUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI); Celgene CorporationTerminatedChronic Lymphocytic Leukemia | B-cell Chronic Lymphocytic Leukemia | Stage 0 Chronic Lymphocytic Leukemia | Stage I Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic LeukemiaUnited States
-
Roswell Park Cancer InstituteWithdrawnRefractory Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic Leukemia | Stage III Chronic Lymphocytic Leukemia | Stage IV Chronic Lymphocytic Leukemia
-
Mayo ClinicNational Cancer Institute (NCI)CompletedChronic Lymphocytic Leukemia | Stage III Small Lymphocytic Lymphoma | Stage IV Small Lymphocytic Lymphoma | Stage 0 Chronic Lymphocytic Leukemia | Stage I Chronic Lymphocytic Leukemia | Stage II Chronic Lymphocytic Leukemia | Stage I Small Lymphocytic Lymphoma | Stage III Chronic Lymphocytic Leukemia and other conditionsUnited States
Clinical Trials on ISF35
-
Januario Castro, M.D.Memgen, LLCTerminatedFollicular Lymphoma | Non-Hodgkin's Lymphoma | Mantle Cell Lymphoma | Chronic Lymphocytic Leukemia | Diffuse Large Cell Lymphoma | Small Lymphocytic LymphomaUnited States
-
Memgen, LLCCompleted
-
Memgen, LLCCompletedChronic Lymphocytic LeukemiaUnited States
-
Memgen, LLCUniversity of California, San Diego; The Leukemia and Lymphoma SocietyCompletedChronic Lymphocytic LeukemiaUnited States
-
University of California, San DiegoMemgen, LLCCompletedChronic Lymphocytic Leukemia | Small Lymphocytic LymphomaUnited States
-
M.D. Anderson Cancer CenterMemgen, LLCWithdrawn