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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA167413 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Dartmouth College | OTHER |
| National Cancer Institute (NCI) | NIH |
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The purposes of the research trial are to study the safety of ABY-029 and to understand how much of the drug is needed to reach brain tumors so it can be visualized best by surgeons. Investigators will do this by comparing two groups of participants that receive different, very small amounts of ABY-029. Investigators will use an imaging system during surgery to record the amount of ABY-029 in the participant's tumor and in the surrounding tissue.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABY-029 6X dose group | Experimental | ABY-029 will be administered at the 6X dose level prior to surgery to participants with presumed high-grade glioma, based on a preoperative MRI or other imaging. Investigators will collect one blood sample before participants are given ABY-029, a second sample one or two minutes after participants are given the drug, a third sample about 15 minutes after participants are given the drug, and a fourth sample about an hour after receiving the drug, or just prior to anesthesia (whichever comes first). Investigators will collect one urine sample and take EKG readings to monitor the participant's heart before surgery. Investigators will repeat blood, urine and EKG tests when participants are in the hospital after surgery. |
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| ABY-029 10X dose group | Experimental | ABY-029 will be administered at the 10X dose level prior to surgery to participants with presumed high-grade glioma, based on a preoperative MRI or other imaging. Investigators will collect one blood sample before participants are given ABY-029, a second sample one or two minutes after participants are given the drug, a third sample about 15 minutes after participants are given the drug, and a fourth sample about an hour after receiving the drug, or just prior to anesthesia (whichever comes first). Investigators will collect one urine sample and take EKG readings to monitor the participant's heart before surgery. Investigators will repeat blood, urine and EKG tests when participants are in the hospital after surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABY-029 | Drug | ABY-029 will be administered via single intravenous injection to subjects with high-grade glioma approximately 1-3 hours prior to surgery. All research procedures will occur during surgery. The research procedures involve image and measurement data collection and biopsy specimen sampling. Research data collection will occur at 3 or 4 time points during surgery using either standard-of-care tools and methods or non-significant risk experimental devices. No follow-up visit will be required of participants. Participants will be monitored for possible adverse events for approximately 30 days by the operating surgeon involved in the clinical trial procedures and through review of participant medical records. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events related to ABY-029 | To study the safety of ABY-029, adverse events related to 6X and 10X doses of ABY-029 will be tracked following surgery, and the proportion of study-drug related adverse events at 6X and 10X doses will be compared statistically for significant differences. | One month |
| False negative rate of ABY-029 fluorescence | To measure of diagnostic performance of ABY-029, the false negative rate of ABY-029 fluorescence measured during surgery in tissue samples that are confirmed to be tumor through pathology. | Up to three months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Keith D Paulsen, PhD | Contact | 603-646-2695 | keith.d.paulsen@dartmouth.edu | |
| Linton Evans, MD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Linton Evans, MD | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock Medical Center | Recruiting | Lebanon | New Hampshire | 03756 | United States |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000626949 | ABY-029 |
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Sixteen participants with EGFR-positive tumors will be enrolled, alternating between two ABY-029 administration doses (the 6X dose and 10X dose), until eight participants with EGFR-positive tumors have been enrolled at each dose group. Because some participants may have EGFR-negative tumors, it may be necessary to enroll up to 33 participants before the target enrollment (eight participants with EGFR-positive tumors at each of two ABY-029 doses) is met.
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| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |