Health TrialsbyHealthPanel

A Study to Evaluate the Safety and Efficacy of L19TNF With Alkylating Chemotherapy for Patients With Recurrent IDH-mutant Astrocytoma or Oligodendroglioma

ConditionGlioma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPhilogen S.p.A.

About this trial

The purpose of this study is to explore the safety and efficacy of the antibody-cytokine fusion protein L19TNF alone or in combination with alkylating chemotherapy in patients with recurrent IDH mutant glioma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18

COHORT 1: Grade ≥2 oligodendroglioma or astrocytoma with planned resection, tumor tissue from prior resection must be available

COHORT 2A: Grade ≥2 oligodendroglioma

COHORT 2B1: Grade ≥2 oligodendroglioma previously treated with lomustine as monotherapy or in combination

Disqualifiers

Any therapy for recurrence/progression after alkylating chemotherapy, except resection.

Therapy for glioma within 4 weeks of start of study treatment.

Surgical resection of glioma within 4 weeks of start of study treatment.

Stereotactic biopsy of glioma within 2 weeks of start of study treatment.

Trial design

Design model

Parallel

Treatments tested in this trial

  • L19TNF

    Biological/Vaccine

    1 cycle of TNF before resection and 6 cycles after surgery

  • L19TNF and TMZ

    Biological/Vaccine

    6 cycles of 28 days with L19TNF and TMZ

  • L19TNF and CCNU

    Biological/Vaccine

    6 cycles of 6 weeks of L19TNF and CCNU every 6 weeks

  • L19TNF monotherapy

    Biological/Vaccine

    6 cycles of 6 weeks with L19TNF

  • L19TNF and TMZ in recurrent astrocytoma

    Biological/Vaccine

    6 cycles of 28 days with L19TNF (D1, D3, D5) and temozolomide chemotherapy TMZ (D1-5).

  • L19TNF and CCNU in recurrent astrocytoma

    Biological/Vaccine

    6 cycles of 6 weeks of L19TNF (D1, D3, D5, D22, D24 and D26) and CCNU (D1) every 6 weeks

  • L19TNF monothery in recurrent oligodendroglioma

    Biological/Vaccine

    6 cycles of 6 weeks with L19TNF

Treatment groups

52 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: 1: perioperative cohort of patients with recurrent astrocytoma or oligodendrogliomaExperimental treatment 1 intervention
Group B: 2A:L19TNF Monotherapy for patients with recurrent oligodendrogliomaExperimental treatment 1 intervention
Group C: 2B1: L19TNF plus TMZ for patients with recurrent oligodendrogliomaExperimental treatment 1 intervention
Group D: 2B2: L19TNF plus CCNU for patients with recurrent oligodendrogliomaExperimental treatment 1 intervention
Group E: 3A: L19TNF monotherapy for patients with recurrent astrocytomaExperimental treatment 1 intervention
Group F: 3B1: L19TNF plus TMZ for patients with recurrent astrocytomaExperimental treatment 1 intervention
Group G: 3B2: L19TNF plus CCNU for patients with recurrent astrocytomaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression-free survival (PFS)

Progression-free survival (PFS) in according to RECIST v.1.1. The duration is defined beginning from randomization to progression or death from any cause.

Time frame
The PFS rate will be assessed at 12 months (PFS-12) in IDH mutant astrocytoma and in oligodendroglioma.

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Philogen S.p.A.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: