This phase I/II trial studies how well recombinant Flt3 ligand, poly-ICLC, and radiation therapy work in treating patients low grade B-cell lymphoma that has not been treated, has come back (relapsed), or does not respond to treatment (refractory). Recombinant Flt3 ligand vaccine may help the body make more immune cells called dendritic cells. The poly-ICLC vaccine stimulates the immune system by activating the dendritic cells. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving recombinant Flt3 ligand, poly-ICLC, and radiation therapy may work better at treating low grade B-cell lymphoma.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01976585.
PRIMARY OBJECTIVE:
I. To determine local and systemic anti-tumor effects of intratumoral injection of recombinant Flt3 ligand (rhuFlt3L/CDX-301) and poly-ICLC combined with local radiation in patients with low-grade B-cell lymphoma.
SECONDARY OBJECTIVE:
I. To determine the feasibility and safety of this treatment regimen.
EXPLORATORY OBJECTIVE:
I. To evaluate humoral and cellular immune responses to the combined treatment regimen.
OUTLINE:
Patients receive recombinant Flt3 ligand intratumorally on days 1-5 and 8-11, and undergo radiation therapy on days 1 and 2. Beginning day 12, patients receive poly-ICLC intratumorally for up to 8 injections on weeks 2-8 in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 4 weeks, every 3-6 months for 12 months, and then every 6-12 months thereafter.
Lead OrganizationIcahn School of Medicine at Mount Sinai
Principal InvestigatorJoshua Brody
