RATIONALE: Vaccines, such as dendritic cell therapy (DC) made from a person's tumor cells and white blood cells may help the body build an effective immune response to kill tumor cells. Cryosurgery kills cancer cells by freezing them. Giving vaccine therapy together with cryosurgery may kill more tumor cells. PURPOSE: This clinical trial studies giving vaccine therapy together with or without cryosurgery in treating patients with B-cell Non-Hodgkin's lymphoma.
PRIMARY OBJECTIVES: I. Evaluation of safety and tolerability as measured by the incidence of significant toxicity of an autologous DC vaccine injection into a cryoablated tumor site (Arm A). II. Evaluation of safety and tolerability as measured by the incidence of significant toxicity of an autologous mature DC vaccine + tumor lysate generated in vitro and delivered intradermally (ID) (Arm B). SECONDARY OBJECTIVES: I. For cryoablation candidates: To assess feasibility, overall response rate, clinical benefit rate, time to response, and duration of response (Arm A). II. For patients receiving ID vaccine without cryoablation: To assess feasibility, clinical response rate, time to response, and duration of response (Arm B). TERTIARY OBJECTIVES: I. For cryoablation candidates: To assess the change over time in non-cryoablated nodes selected as the index lesions (Arm A). II. For patients receiving ID vaccine without cryoablation: To assess the change over time in measurable nodes selected as the index lesions (Arm B). III. To monitor patients' immune response after vaccine therapy. IV. Assess the immune response to Prevnar in cancer patients. V. Assess the effect of DC vaccination on presence of myeloid suppressors. VI. Assess the effect of tumor antigen delivery methods (in vivo DC into cryoablated tumor vs. ID injection of in vitro generated DC + lysate) on T cell response. OUTLINE: Patients are assigned to 1 of 2 treatment arms. In both arms, treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 1 year, and then every 6 months for up to 2.5 years.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Given intratumorally
Undergo cryoablation
Given intramuscularly
Correlative studies
Correlative studies
Correlative studies
Given intradermally
Mayo Clinic
Rochester, Minnesota, United States
Incidence of significant toxicity as assessed by the CTEP Active Version CTCAE
Time frame: At day 1 of each course beginning in week 2, every 3 months for 1 year, and during documented progressive disease
Overall response rate
Time frame: At week 4 (arm A) or 2 (arm B) and then every 3 months for 1 year starting at week 10
Feasibility as estimated by the number of patients receiving at least one dose of tumor antigen loading and vaccine delivery divided by the number receiving leukapheresis
Time frame: Up to 2.5 years
Clinical benefit rate as estimated by the number of patients with an objective status of stable disease (SD) or an objective status of CR or PR
Time frame: For at least 12 months
Time to response
Time frame: From the date of initiation of vaccination treatment to the date at which the patient's objective status is first noted to be either a CR or PR
Duration of response
Time frame: From the date at which the patient's objective status is first noted to be either a CR or PR to the earliest date progression is documented
Percent change from baseline in index lesion measurements as a marker of distant immune and treatment response
Time frame: At day 1 of courses 1-4 (arm A) and 1-6 (arm B)
Change in immunologic correlates before and after vaccination treatment
Time frame: At day 1 of each course beginning in week 2, every 3 months for 1 year, and during documented progressive disease
Correlation of immunologic markers with cancer and treatment-related outcomes (e.g., response, toxicities)
Time frame: Up to 2.5 years
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