An Expanded Access Program of Ipilimumab for Patients With Glioblastomas and Gliomas
1 other identifier
expanded_access
N/A
8 countries
11
Brief Summary
IPILIMUMAB Extended Access Program for patients who received chemotherapy and / or radiation therapy before the protocol, before or after the operation.
Trial Health
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11 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2018
CompletedFirst Posted
Study publicly available on registry
March 9, 2018
CompletedNovember 8, 2019
November 1, 2019
March 5, 2018
November 6, 2019
Conditions
Keywords
Interventions
Each patient receives Ipilimumab in regimen and dose according to the official manufacturer's instructions (IV 1 mg / kg every 6 weeks for maximum of 4 doses). Participation of the patient in the program must necessarily be agreed with the current treatment and contain a written agreement with the attending physician. This program is not covered by health insurance. For patients in the postoperative period to provide a mandatory conclusion of histology and molecular-genetic for the identified mutations and the type of tumor.
Eligibility Criteria
You may qualify if:
- 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 ≥60.
- 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.
- A contrast-enhanced MRI must be obtained within 7 days of the first dose of study treatment.
- Adequate hematologic, hepatic, and renal function defined by test
- Women must have a negative serum or urine pregnancy test before 24 hours of initiation of study drug.
- Any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL to be defined as post-menopausal.
- Women receiving ipilimumab will be instructed to adhere to contraception for a period of 35 weeks after the last dose of program.
- +6 more criteria
You may not qualify if:
- 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.
- Active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent.
- Prior organ transplantation, including allogeneic stem cell transplantation.
- Known history of, or any evidence of active, non-infectious pneumonitis within the last 5 years.
- Known severe (NCI-CTCAE v4.03 Grade 3 or 4) infusion-related allergy or acute hypersensitivity reaction attributed to any monoclonal antibody, any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma).
- Unable tolerate an MRI, or have a contraindication to MRI.
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Center Trials & Treatmentlead
- BioGene Pharmaceutical Inc.collaborator
Study Sites (11)
University "Mother Theresa" Hospital Center; Oncology Department
Tirana, 1000, Albania
University Clinical Center of the Republic of Srpska
Banja Luka, 78000, Bosnia and Herzegovina
Complex Oncology Center
Plovdiv, 4004, Bulgaria
Clinical Hospital Osijek; Dept For Oncology & Radiotherapy
Osijek, 31000, Croatia
Institut of Oncology Al. Trestioreanu Bucharest; Oncology
Bucharest, 022338, Romania
Regional Oncology Hospital
Irkutsk, 664035, Russia
Rostov Cancer Research Institute
Rostov-on-Don, 344037, Russia
Primorsky Regional Oncology Center
Vladivostok, 690069, Russia
Clinical Hospital Center Bezanijska kosa; Clinic for Oncology
Belgrade, 11 000, Serbia
Inselspital Bern; Medizinische Onkologie
Bern, 3010, Switzerland
Stadtspital Triemli; Frauenklinik
Zurich, 8063, Switzerland