Clinical trial

Radio-Immuno-Modulation for Advanced Lung Cancer: a Pilot Study Evaluating Tolerance and Immune Responses

Name

2012-634

Description

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.

Trial arms

Trial start

2018-04-20

Estimated PCD

2024-10-01

Trial end

2025-04-01

Phase

Early phase I

Treatment

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.

Arms:

Patients with a living donor

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.

Arms:

Patients with a UCB donor

Size

Primary endpoint

Incidence of treatment-related adverse events

Up to 6 months

Eligibility criteria

Inclusion criteria: * Advanced lung cancer documented by a histo-pathological analysis; * Patients who received at least one line of anti neoplastic therapy; * Presence of at least one tumor mass \>1 cm and not previously irradiated; * Metastases situated in one of the following sites: lung, skeleton, lymph nodes or soft tissue; * Presence of at least one not previously irradiated metastasis; * Life expectancy greater than 3 months; * ECOG performance status ≤ 2. Exclusion criteria: * Second active cancer necessitating treatment; * History of autoimmune disease; * Patients dependent on immunosuppressive medications, including corticosteroids; * Decreased diffusion capacity below 40%, if radiation planned to a lung metastasis; * Patients needing urgent radiotherapy.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 24, 'type': 'ESTIMATED'}}

Updated at

2024-02-29

1 organization

2 products

1 indication

Organization

Hopital du Sacre-Coeur de Montreal

Product

Patients with a living donor

Indication

lung cancer

Product

UCB