An Expanded Access Program of Ipilimumab for Patients With Glioblastomas and Gliomas
Primary Purpose
Glioblastoma, Glioma of Brain
Status
No longer available
Phase
Locations
International
Study Type
Expanded Access
Intervention
Ipilimumab
Sponsored by
About this trial
This is an expanded access trial for Glioblastoma focused on measuring Ipilimumab, Glioblastoma, Glioma
Eligibility Criteria
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 ≥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.
- Men receiving ipilimumab and who are sexually active will be instructed to adhere to contraception for a period of 39 weeks after the last dose of program.
- Contraception is not required for men with documented vasectomy.
- Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.
- Women must not be breastfeeding.
- Willing to and capable of providing written informed consent prior to any program related procedures.
- Ability and willingness to comply scheduled visits, treatment plans, laboratory tests, and other program-related procedures.
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.
- 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.
- Active infection requiring systemic therapy.
- Positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome.
- Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus (HCV antibody) indicating acute or chronic infection.
- Vaccination within 5 weeks of the first dose of study drug and while on trials is prohibited except for administration of inactivated vaccines.
ATTENTION: Seasonal influenza vaccines for injection are live attenuated vaccines, and are not allowed.
- Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ NY Heart Association - CC II), or serious cardiac arrhythmia requiring medication.
- All other unstable, severe, or chronic medical or psychiatric conditions including colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis, recent (within the past year) or active suicidal idea in behavior, or laboratory abnormalities that may increase the risk associated with program or judgment of the investigator, would make the patient participation impossible.
Sites / Locations
- University "Mother Theresa" Hospital Center; Oncology Department
- University Clinical Center of the Republic of Srpska
- Complex Oncology Center
- Clinical Hospital Osijek; Dept For Oncology & Radiotherapy
- Institut of Oncology Al. Trestioreanu Bucharest; Oncology
- Regional Oncology Hospital
- Rostov Cancer Research Institute
- Primorsky Regional Oncology Center
- Clinical Hospital Center Bezanijska kosa; Clinic for Oncology
- Inselspital Bern; Medizinische Onkologie
- Stadtspital Triemli; Frauenklinik
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT03460782
First Posted
March 5, 2018
Last Updated
November 6, 2019
Sponsor
Center Trials & Treatment
Collaborators
BioGene Pharmaceutical Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03460782
Brief Title
An Expanded Access Program of Ipilimumab for Patients With Glioblastomas and Gliomas
Official Title
An Expanded Access Program of Ipilimumab for Patients With Glioblastomas and Gliomas
Study Type
Expanded Access
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center Trials & Treatment
Collaborators
BioGene Pharmaceutical Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma, Glioma of Brain
Keywords
Ipilimumab, Glioblastoma, Glioma
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Ipilimumab
Other Intervention Name(s)
MDX-010
Intervention Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Eligibility Criteria
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 ≥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.
Men receiving ipilimumab and who are sexually active will be instructed to adhere to contraception for a period of 39 weeks after the last dose of program.
Contraception is not required for men with documented vasectomy.
Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.
Women must not be breastfeeding.
Willing to and capable of providing written informed consent prior to any program related procedures.
Ability and willingness to comply scheduled visits, treatment plans, laboratory tests, and other program-related procedures.
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.
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.
Active infection requiring systemic therapy.
Positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome.
Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus (HCV antibody) indicating acute or chronic infection.
Vaccination within 5 weeks of the first dose of study drug and while on trials is prohibited except for administration of inactivated vaccines.
ATTENTION: Seasonal influenza vaccines for injection are live attenuated vaccines, and are not allowed.
Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ NY Heart Association - CC II), or serious cardiac arrhythmia requiring medication.
All other unstable, severe, or chronic medical or psychiatric conditions including colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis, recent (within the past year) or active suicidal idea in behavior, or laboratory abnormalities that may increase the risk associated with program or judgment of the investigator, would make the patient participation impossible.
Facility Information:
Facility Name
University "Mother Theresa" Hospital Center; Oncology Department
City
Tirana
ZIP/Postal Code
1000
Country
Albania
Facility Name
University Clinical Center of the Republic of Srpska
City
Banja Luka
ZIP/Postal Code
78000
Country
Bosnia and Herzegovina
Facility Name
Complex Oncology Center
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Facility Name
Clinical Hospital Osijek; Dept For Oncology & Radiotherapy
City
Osijek
ZIP/Postal Code
31000
Country
Croatia
Facility Name
Institut of Oncology Al. Trestioreanu Bucharest; Oncology
City
Bucharest,
ZIP/Postal Code
022338
Country
Romania
Facility Name
Regional Oncology Hospital
City
Irkutsk
ZIP/Postal Code
664035
Country
Russian Federation
Facility Name
Rostov Cancer Research Institute
City
Rostov-on-Don
ZIP/Postal Code
344037
Country
Russian Federation
Facility Name
Primorsky Regional Oncology Center
City
Vladivostok
ZIP/Postal Code
690069
Country
Russian Federation
Facility Name
Clinical Hospital Center Bezanijska kosa; Clinic for Oncology
City
Belgrade
ZIP/Postal Code
11 000
Country
Serbia
Facility Name
Inselspital Bern; Medizinische Onkologie
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Stadtspital Triemli; Frauenklinik
City
Zürich
ZIP/Postal Code
8063
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
An Expanded Access Program of Ipilimumab for Patients With Glioblastomas and Gliomas
We'll reach out to this number within 24 hrs