Dendritic Cell Therapy, Cryosurgery, and Pembrolizumab in Treating Patients With Non-Hodgkin Lymphoma

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT03035331
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Aggressive Non-Hodgkin Lymphoma
  • Indolent Non-Hodgkin Lymphoma
  • Recurrent Diffuse Large B-Cell Lymphoma
  • Recurrent Follicular Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Recurrent Marginal Zone Lymphoma
  • Recurrent Non-Hodgkin Lymphoma
  • Recurrent Primary Mediastinal (Thymic) Large B-Cell Lymphoma
  • Recurrent T-Cell Non-Hodgkin Lymphoma
  • Small Lymphocytic Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cryosurgery — PROCEDURE
    Undergo cryosurgery
  • Dendritic Cell Therapy — BIOLOGICAL
    Given IT
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Pembrolizumab — BIOLOGICAL
    Given IV
  • Pneumococcal 13-valent Conjugate Vaccine — BIOLOGICAL
    Given by injection
  • Quality-of-Life Assessment — OTHER
    Ancillary studies

Study Details

This phase I/II trial studies the best dose and side effects of dendritic cell therapy, cryosurgery and pembrolizumab in treating patients with non-Hodgkin lymphoma. Vaccines, such as dendritic cell therapy 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. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving dendritic cell therapy, cryosurgery and pembrolizumab may work better at treating non-Hodgkin lymphoma.

Key Dates

Start date
Aug 15, 2017
Status verified
Dec 2024
Primary completion
Jan 25, 2022
Completion
Sep 10, 2022

Study Design

Enrollment
11 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (pembrolizumab, dendritic cell therapy, cryosurgery)
    Patients receive pembrolizumab IV on day 1. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive dendritic cell therapy IT on days 2, 8, and 15 of cycles 2 and 3, and day 2 of cycles 4 and 5. Patients undergo cryosurgery on day 2 of cycle 2 and receive pneumococcal 13-valent conjugate vaccine by injection on day 2 of cycles 2-5. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Patients who are CR, PR, or SD after completion of therapy, may receive pembrolizumab for an additional 18 cycles in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Number of Patients That Experienced a Dose Limiting Toxicity (DLT) [ Time Frame: 56 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905-

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Mayo Clinic in Rochester· Rochester, MN

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