Autologous Cytomegalovirus (CMV)-Specific Cytotoxic T Cells for Glioblastoma (GBM) Patients
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ClinicalTrials.gov Identifier: NCT02661282 |
Recruitment Status
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Recruiting
First Posted
: January 22, 2016
Last Update Posted
: March 14, 2018
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Tracking Information | |||||
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First Submitted Date ICMJE | January 14, 2016 | ||||
First Posted Date ICMJE | January 22, 2016 | ||||
Last Update Posted Date | March 14, 2018 | ||||
Actual Study Start Date ICMJE | June 2016 | ||||
Estimated Primary Completion Date | June 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT02661282 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
Overall Survival (OS) [ Time Frame: 6 months ] Dose Expansion Newly Diagnosed Glioblastoma Group Post Radiotherapy + Temozolomide: Overall survival (OS) defined as the time from definitive histological diagnosis until the time of death.
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Original Secondary Outcome Measures ICMJE |
Tumor Response [ Time Frame: 6 weeks ] Newly Diagnosed Glioblastoma Group: MRI of the brain performed to check the status of the disease.
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Current Other Outcome Measures ICMJE | Not Provided | ||||
Original Other Outcome Measures ICMJE | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Autologous Cytomegalovirus (CMV)-Specific Cytotoxic T Cells for Glioblastoma (GBM) Patients | ||||
Official Title ICMJE | A Phase I/II Clinical Trial of Autologous Cytomegalovirus (CMV)-Specific Cytotoxic T Cells for Glioblastoma (GBM) Patients | ||||
Brief Summary | The goal of Phase I of this clinical research study is to find the highest tolerable dose of cytomegalovirus cytotoxic T lymphocytes (CMV CTLs) that can be given in combination with temozolomide to patients with glioblastoma. The goal of Phase II of this study is to learn if CMV CTLs combined with temozolomide can help to control glioblastoma. The safety of this combination will also be studied. This is an investigational study. CMV CTLs are not FDA approved or commercially available. They are currently being used for research purposes only. Temozolomide is FDA approved and commercially available for the treatment of some brain tumors, including glioblastoma. The use of this combination to treat glioblastoma is investigational. The study doctor can explain how the study drug/cells are designed to work. Up to 54 participants will be enrolled in this study. All will take part at MD Anderson. |
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Detailed Description | Study Groups: If you are found to be eligible to take part in this study, you will be assigned to a study phase based on when you join this study. If you are enrolled in the Phase I Dose Escalation part (Group 1), up to 4 dose levels of CMV CTLs will be studied in this Phase I part. Up to 6 participants will be enrolled at each dose level. The first 3-6 of participants will receive the lowest dose level. Each 3-6 new participants will receive a higher dose of the study drugs than the participants before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of CMV CTLs is found. If you are enrolled in the Phase II Dose Expansion part, you will receive CMV CTLs at the highest dose that was tolerated in Phase 1. You will be assigned to 1 of 2 study groups (Groups 2 and 3) based on the status of the disease and the treatment you received previously.
Study Drug/Cell Administration: There are 42 days in each cycle during Cycles 1-4. If you are in Group 1 or 2, Cycles 5 and beyond will also have 42 days. If you are in Group 3, Cycles 5 and beyond will have 28 days. On Day 0, the day you enroll in the study, you will have leukapheresis performed over 2-3 hours to collect white blood cells, including a type called T cells. Leukapheresis uses a machine to remove white cells from the blood. These white blood cells will be used to make CMV CTLs for your treatment later, starting on Day 22 of Cycle 1. For the leukapheresis procedure, you will lie on a bed or lean back in a chair, with a tube in a vein in each arm. One tube removes blood and passes it into a machine that removes white blood cells, including T cells. The rest of your blood will go back into your body through the tube in your other arm. After leukapheresis, you will start receiving temozolomide and CMV CTLs. You will take temozolomide capsules by mouth 1 time a day on Days 1-21 of Cycles 1-4. If you are in Group 1 or 2, you will continue taking temozolomide on Days 1-21 of Cycles 5 and beyond. If you are in Group 3, you will take temozolomide on Days 1-5 of Cycles 5 and beyond. You should take temozolomide at bedtime at about the same time each day. Temozolomide should be taken on an empty stomach (at least 2 hours before or after eating) with 1 cup (about 8 ounces) of water. You should swallow the temozolomide capsules whole, one right after the other, without chewing them. If you vomit the study drug, do not make up the dose. You should take the next scheduled dose at the usual time. The capsules of temozolomide should not be opened. If a capsule is damaged or broken, you should avoid letting the capsule contents have contact with your skin or mucous membranes. Spills of powder from temozolomide capsules should be cleaned up carefully. If you come in contact with the powder, you should wash your hands very well. If the spill is on a surface, the area must be washed at least 3 times with rubbing alcohol, followed by water. You will receive CMV CTLs by vein over 1-5 minutes on Day 22 of Cycles 1-4. After the infusions, you will need to stay in the clinic for up to 1 hour so the study staff can check on you. Before you receive CMV CTLs, you will be given standard drugs to help decrease the risk of side effects. You may ask the study staff for information about how the drugs are given and their risks. If you are in Group 2, on Day 30 of Cycle 1, you will have surgery to remove the tumor as part of routine care. You will sign a separate consent form that describes the procedure and risks. Leftover tumor tissue from surgery will be collected and used for biomarker testing. After recovering from surgery (which may take about 14 days), you will start receiving temozolomide on Day 1 of Cycle 2. Study Visits for All Groups: On Day 1 of every cycle:
On Days 8, 15, 22, 29, and 36 of Cycle 1, and then on Days 22 and 29 of Cycles 2-4, blood (about 1 teaspoon) will be drawn for routine tests. If the disease gets worse during study treatment and you will be having surgery as part of standard care, leftover tumor tissue from surgery will be collected for biomarker testing. Study Visits for Group 1: On Days 15 and 29 of Cycles 5 and beyond, blood (about 1 teaspoon) will be drawn for routine tests. Every 6 weeks, you will have an MRI of the brain. On Days 22 and 30 of Cycles 1-4, on Day 1 of Cycles 2-5 and on Day 34 of Cycle 8, blood (about 4 tablespoons) will be drawn for biomarker testing. Study Visits for Group 2: On Days 15 and 29 of Cycles 5 and beyond, blood (about 1 teaspoon) will be drawn for routine tests. Every 6 weeks starting in Cycle 3, you will have an MRI of the brain. Within 48 hours before surgery, blood (about 4 tablespoons) will be drawn for biomarker testing. Within 24 hours before surgery, you will have an MRI of the brain. On Day 30 of Cycle 1, you will have surgery to remove the tumor as part of routine care. Blood (about 4 tablespoons) will be drawn for biomarker testing. Within 2 days after surgery, you will have an MRI of the brain. After you have recovered from surgery, you will start back up with your study visits. Blood (about 4 tablespoons) will be drawn for biomarker testing on the following schedule:
Study Visits for Group 3: Every 6 weeks for Cycles 2-4, then every 8 weeks, you will have an MRI of the brain. On Days 22 and 30 of Cycles 1-4, on Day 1 of Cycles 2-5 and on Day 20 of Cycle 10, blood (about 4 tablespoons) will be drawn for biomarker testing. At any time during the study, if the doctor thinks it is needed, you may have 1 or more of the above tests repeated for your safety. Length of Treatment: You will receive the CMV CTLs for up to 4 cycles and temozolomide for up to 12 cycles. You will no longer be able to take the study drug/cells if the disease gets worse, if you have intolerable side effects, or if you are unable to follow study directions. You will need to stop receiving CMV CTLs early if not enough CTLs are available. Follow-Up: The study staff will call and ask how you are feeling on the following schedule:
These calls should take about 5-10 minutes each time. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
54 | ||||
Original Estimated Enrollment ICMJE |
30 | ||||
Estimated Study Completion Date | June 2021 | ||||
Estimated Primary Completion Date | June 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT02661282 | ||||
Other Study ID Numbers ICMJE | 2014-0899 NCI-2016-00183 ( Registry Identifier: NCI CTRP ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||
Responsible Party | M.D. Anderson Cancer Center | ||||
Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | M.D. Anderson Cancer Center | ||||
Verification Date | March 2018 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |