Study of Repeat Intranodal Injection of Memgen's Cancer Vaccine, Ad-ISF35, in Subjects With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

Stopped early · Phase 2

Conditions studied: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

In brief

This is a Phase II, open label, fixed dose, repeat injection, single institution study. Eligible subjects will receive up to six doses of Ad-ISF35 injected directly into a selected lymph node under ultrasound guidance. The primary goal is to determine and monitor clinical and biological responses in patients treated with repeat intranodal injections of Ad-ISF35.

Key facts

Study ID: NCT00849524
Run by: Januario Castro, M.D.
People needed: 6
Starts: 2009-01-01
Expected to finish: 2014-07-01
Last updated by the study team: 2015-12-30

Who can join

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

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

University of California, San Diego Moores Cancer Center — La Jolla, California, United States

Full record on ClinicalTrials.gov

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