This Phase I trial studies the safety and efficacy of vaccine therapy in treating patients with previously untreated chronic lymphocytic leukemia. Liposome-based vaccines containing an extract of a person's cancer cells and the immunostimulant interleukin-2 may help the body to build an effective immune response to kill cancer cells.
PRIMARY OBJECTIVES: I. To evaluate the safety of vaccination with Oncoquest-Chronic Lymphocytic Leukemia (CLL) vaccine (autologous tumor cell extract vaccine). II. To evaluate the feasibility of Oncoquest-CLL production and administration to previously untreated patients with CLL. SECONDARY OBJECTIVES: I. To evaluate the clinical response \[as defined by the International Workshop on Chronic Lymphocytic Leukemia 2008 (iwCLL2008)\] of the Oncoquest-CLL vaccine in treatment-naive patients with CLL. II. To evaluate the T and B cell immune responses against autologous leukemia cells induced with Oncoquest-CLL vaccine. III. To measure the progression-free survival of patients treated with the Oncoquest-CLL vaccine. IV. To evaluate the change in absolute lymphocyte count and lymphocyte doubling time before and after vaccine administration and correlate this with immune response. OUTLINE: Patients receive autologous tumor vaccine subcutaneously (SC) on Study Day 1 and 15, and then monthly for 3 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up monthly for 3 months, and then every 3 months for up to 1 year.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Comparison of 4 different dose levels of Oncoquest-CLL vaccine: 100 micrograms (mcg)/0.2 milliliters (mL), 200 mcg/0.4 mL, 375 mcg/0.75 mL, and 500 mcg/mL. Patients will receive a total of 5 doses of vaccines; the first 2 doses separated by 2 week intervals and the last 3 doses by 1 month intervals. Vaccine will be given by sc injections in 2 sites in upper arms or legs.
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States
Incidence of adverse events graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Safety data will be tabulated for all patients and include vital signs, laboratory parameters, and adverse events. Toxicities will be summarized descriptively by type and attribution.
Time frame: Up to 30 days post-vaccination
Feasibility in terms of vaccine production.
The rate of successful production of the vaccine will be calculated. Successful production (feasibility) will be dichotomous. Dichotomous outcomes will be summarized using proportions and exact 95% binomial confidence intervals.
Time frame: Up to 4 weeks.
Feasibility in terms of vaccine delivery.
The rate of successful delivery of the vaccine will be calculated. Successful delivery (feasibility) will be dichotomous. Dichotomous outcomes will be summarized using proportions and exact 95% binomial confidence intervals.
Time frame: Up to 15 weeks.
Clinical response evaluated using IWCLL2008 guidelines.
Clinical response to vaccination will be evaluated by parameters of reduction in leukemia cell count, lymph node size, liver and spleen size, and reduction in amount of disease in bone marrow) and improved hematologic parameters (including hemoglobin and platelet count).
Time frame: Up to 1 year.
In vitro immune response evaluated using T-cell and B-cell immune responses.
T-cell and B-cell responses will be summarized using medians and nonparametric confidence intervals.
Time frame: Up to 1 year.
Progression-free survival.
Time frame: Up to 1 year.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Change in absolute lymphocyte count.
Time frame: Baseline to up to 1 year.
Change in lymphocyte doubling time.
Time frame: Baseline to up to 1 year.