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Radio-Immuno-Modulation in Lung Cancer

NCT02579005 · Status: SUSPENDED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-02-29

No results posted yet for this study

Summary

This project will assess the feasibility of treating advanced cancer using the immune system, without any anti-cancer drug. In this pilot study, the investigators propose combining low-dose radiotherapy, in lung cancer patients, with allogeneic immune cells obtained from a donor. The patients will receive radiotherapy directed to one of the patient's tumors, as well as an immunomodulatory drug called cyclophosphamide. Thereafter, they will receive the infusion of donor immune cells.

Conditions

Interventions

BIOLOGICAL

Patients with a living donor

The day of allogeneic cell infusion will be referred to as Day 0 and the n-th day before that, as Day -n. The dose of external radiation will be 15 Gy divided in 3 fractions, from Day -3. Cyclophosphamide, 250 mg/m2 will be given on Day -2. Donors will receive 5 daily doses of GCSF, 10 µg/kg, by subcutaneous injection from Day -4. PBMC will be collected through apheresis on Day 0. A dose of 5 x 10exp7 CD3 cells/kg will be administered. The infused volume will be adjusted to contain this T cell dose.

BIOLOGICAL

Patients with a UCB donor

The day of allogeneic cell infusion will be referred to as Day 0 and the n-th day before that, as Day -n. The UCB unit should have at least 4 of 6 HLA compatibility and at least 3 x 10exp6 TNC per kg patient weight. The dose of external radiation will be 15 Gy, divided in 3 fractions, starting on Day -3. Cyclophosphamide, 250 mg/m2 intravenously, will be given on Day -2.

Sponsors & Collaborators

  • Maisonneuve-Rosemont Hospital

    collaborator OTHER

  • Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

    lead OTHER

Principal Investigators

  • Razvan B Diaconescu, MD · CIUSSS du Nord-de-l'Île-de-Montréal - Hôpital du Sacré-Cœur de Montréal

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-20
Primary Completion
2024-10-31
Completion
2025-04-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02579005 on ClinicalTrials.gov