Study on Vaccination with Flt3L, Radiation, and Poly-ICLC for Cancer Treatment

Sponsor: Icahn School of Medicine at Mount Sinai

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03789097

Provider View

This clinical trial is exploring a new combination of treatments involving a vaccine, radiation, and immune-boosting drugs to target specific cancer sites. The study aims to determine the safety and effectiveness of this approach in treating certain types of cancer.

Patient Parameters

Program Overview

This study involves a combination of four treatments aimed at a specific cancer site, like a lymph node or tumor. Three treatments are applied directly to the cancer site, while the fourth is given through an IV. The treatments include: 1) Radiation, which uses low doses to target the cancer site; 2) Flt3L, a drug that helps the body produce more immune cells; 3) Poly-ICLC, which activates immune cells to attack the cancer; and 4) Pembrolizumab, an antibody that helps the immune system target cancer cells. The study will assess if this combination can effectively treat certain cancers.

Description

The study is divided into two phases:

Phase 1: This phase focuses on assessing the safety of the treatment combination. It will involve a small group of patients to monitor any side effects. If the treatment is found to be safe, the study will move to Phase 2.

Phase 2: This phase will evaluate how well the treatment works in shrinking tumors. Patients will be grouped based on their type of cancer, such as non-Hodgkin's lymphoma, metastatic breast cancer, or head and neck cancer. The study will continue if the treatment shows promise in at least a few patients in each group.

Patients will be enrolled in different groups based on their cancer type. The study will include patients who have previously received certain cancer treatments. The goal is to see if this new combination can improve outcomes for patients with these cancers.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of certain types of cancer, such as non-Hodgkin's lymphoma, metastatic breast cancer, or head and neck cancer.
  • Specific subtypes of lymphoma may be included, such as small lymphocytic lymphoma.

Exclusion Criteria

  • Currently participating in another study or receiving investigational treatments.
  • Require immediate treatment for their cancer.
  • Have certain types of lymphoma or cancer that are progressing rapidly.
  • Have a weakened immune system or are on immunosuppressive therapy.
  • Have allergies to any of the study drugs.
  • Have had recent cancer treatments or surgeries without full recovery.
  • Have active brain metastases or certain other medical conditions.
  • Have active infections or other cancers requiring treatment.
  • Are pregnant, breastfeeding, or planning to have children during the study.
  • Have certain viral infections like HIV or hepatitis.
  • Have had organ transplants or received live vaccines recently.

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