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Clinical Trials/NCT03460782
NCT03460782
No Longer Available
Not Applicable

An Expanded Access Program of Ipilimumab for Patients With Glioblastomas and Gliomas

Center Trials & Treatment11 sites in 8 countriesStarted: March 9, 2018Last updated:
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ConditionsGlioblastomaGlioma of Brain

Overview

Phase
Not Applicable
Status
No Longer Available
Sponsor
Center Trials & Treatment
Locations
11
OverviewEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

IPILIMUMAB Extended Access Program for patients who received chemotherapy and / or radiation therapy before the protocol, before or after the operation.

Detailed Description

It is not yet known which protocols are a better treatment for glioblastoma or glioma.

The ipilimumab extended-access program for patients who received previous chemotherapy and / or radiation therapy by protocol, before ((for non-operable cases) or after the operation.

Monoclonal antibodies of CTLA-4, such as ipilimumab, may block tumor growth in different ways by targeting certain cells and activating the patient's immune system to fight the disease.

Study Design

Study Type
Expanded Access

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Glioblastoma.
  • •Glioma Brain.
  • •Male or female subjects aged ≥18 years.
  • •Histopathological evidence of glioblastoma or glioma.
  • •Patients still alive must provide informed consent if required by local regulations
  • •Maximal tumor diameter (including residual tumor and resection cavity if subjects had tumor resection rather than only stereotactic biopsy) up to 7cm or less.
  • •Karnofsky performance status (Appendix 2) of ≥
  • •Availability of a paraffin-embedded or frozen tumor-tissue block with a minimum of 0.5 cm2 and 5 unstained slides from the glioblastoma or glioma tissue specimen.
  • •Not earlier than 35 days after surgery.
  • •An interval of at least 2 week for stereotactic biopsy from the start of study treatment.

Exclusion Criteria

  • •Prior systemic treatment anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways.
  • •Planned participation in another study intended for therapy of glioma or glioblastoma.
  • •Primary brainstem or spinal cord tumor.
  • •Diffuse leptomeningeal gliomatosis.
  • •Сonfirmed mutation of the IDH1/2 genes.
  • •Stem or dendritic cell therapy 60 days before the program or 45 days after the last infusion of ipilimumab.
  • •Systemic treatment with either immunosuppressive doses of corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 21 days of study drug administration.
  • •Patients on a standard high-dose steroid taper after craniotomy or stereotactic biopsy may have received a higher dose of corticosteroids within 21 days of registration, however must be at a dose \< 5 mg daily prednisone or bioequivalent per day within 7 days prior to initiation of study drug.
  • •Patients requiring adrenal replacement with corticosteroids are eligible if the steroids are at doses ≤ 10 mg prednisone or bioequivalent per day in the absence of active autoimmune disease.
  • •Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) are allowed.

Investigators

Sponsor
Center Trials & Treatment
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (11)

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