LS1081, "A Pilot Study of Dendritic Cell Therapy Delivered Intratumorally After Cryoablation or Intradermally for 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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Incidence of significant toxicity as assessed by the CTEP Active Version CTCAE
At day 1 of each course beginning in week 2, every 3 months for 1 year, and during documented progressive disease
Yi Lin, M.D.
United States: Food and Drug Administration
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