Trial of Newly Diagnosed High Grade Glioma Treated With Concurrent Radiation Therapy, Temozolomide and BMX-001 (BMX-HGG)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02655601 |
Recruitment Status :
Active, not recruiting
First Posted : January 14, 2016
Last Update Posted : July 13, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
High Grade Glioma Astrocytoma, Grade III Glioblastoma | Drug: BMX-001 Radiation: Radiation Therapy Drug: Temozolomide | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 160 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2 Trial for Patients With Newly Diagnosed High Grade Glioma Treated With Concurrent Radiation Therapy, Temozolomide, and BMX-001 |
Actual Study Start Date : | September 25, 2018 |
Estimated Primary Completion Date : | December 2022 |
Estimated Study Completion Date : | July 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Radiation Therapy, TMZ and BMX-001
Patients will receive standard of care radiation therapy plus temozolomide (TMZ). BMX-001 will be given by subcutaneous injection with a loading dose of 28 mg/subject given within 4 days prior to initiation of radiation therapy and followed by biweekly maintenance doses at half the loading dose for a total of 8 weeks. A total of 80 subjects will receive BMX-001 in this phase.
|
Drug: BMX-001
BMX-001 consists of a porphyrin ring with pyridyl groups attached at each of the four methane bridge carbons. The nitrogen in the pyridyl ring is at the 2 position and has a side chain consisting of six carbons with an ether linkage. A manganese atom is chelated into the porphyrin ring and is the active center of the molecule. This molecule is an enzymatic scavenger of free radical species operating at close to diffusion-limited rates.
Other Name: manganese butoxyethyl pyridyl porphyrin Radiation: Radiation Therapy RT will be delivered in daily fractions of 1.8-2 Gy given 5 days a week for 6 weeks for a total of 59.4-60 Gy. Drug: Temozolomide Initially, temozolomide (TMZ) will be dosed at 75 mg/m2 orally daily for 42 days. Two weeks after the completion of chemoradiation, patients will transition to adjuvant chemotherapy with TMZ dosed at 150-200 mg/m2 orally for 5 days of a 28-day cycle for a total of 12 cycles.
Other Name: TMZ |
Active Comparator: Radiation Therapy and TMZ
In this arm, one-half of the study subjects will not receive BMX-001 but will undergo all components of standard therapy (radiation therapy plus temozolomide [TMZ]). A total of 80 subjects will be in this study arm.
|
Radiation: Radiation Therapy
RT will be delivered in daily fractions of 1.8-2 Gy given 5 days a week for 6 weeks for a total of 59.4-60 Gy. Drug: Temozolomide Initially, temozolomide (TMZ) will be dosed at 75 mg/m2 orally daily for 42 days. Two weeks after the completion of chemoradiation, patients will transition to adjuvant chemotherapy with TMZ dosed at 150-200 mg/m2 orally for 5 days of a 28-day cycle for a total of 12 cycles.
Other Name: TMZ |
- Phase 2 - Overall survival [ Time Frame: 2 years ]Assessment of overall survival. With standard treatment, the median survival of Grade IV patients is expected to be 14.6 months, and the median survival of Grade III is approximately 36 months. Given that we anticipate that approximately 10% of patients to be Grade III, we estimate that the overall median survival with standard treatment to be roughly 16.7 months.
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 10 weeks ]Safety and tolerability of BMX-001 in combination with standard radiation therapy and temozolomide in newly diagnosed high grade glioma patients will be assessed as the proportion of patients with a serious adverse event (SAE).
- Progression-free survival [ Time Frame: 2 years ]Progression-free survival will be assessed as the time between initiation of protocol treatment and the first recurrence of disease or death.
- Protection/improvement of cognition [ Time Frame: 1 year ]
Neurocognitive testing will be done using Brief Assessment of Cognition (BAC) through the NeuroCog app. This battery consists of the six tests listed below.
- Verbal memory & learning test will assess verbal learning, memory for words, and recall.
- Working memory test will assess digital sequencing when presented with auditory clusters of numbers.
- Motor function test will assess motor skills using manipulation of tokens.
- Verbal fluency test includes both semantic fluency (number of words generated in a given category) and letter fluency (number of words beginning with a given letter).
- Speed of processing will be tested using ability to match corresponding numbers with a series of symbols.
- Executive function will be assessed by a Tower of London subtest. Cognitive testing will be obtained at screening, 2 weeks after the completion of standard RT and TMZ, and every 8 weeks during adjuvant TMZ.
- Radiographic response to tumor. [ Time Frame: 2 years ]The guidelines and criteria for radiographic response will be based on the updated RANO criteria for newly diagnosed GBM. MRI brain with and without contrast will be obtained at enrollment, 2-4 weeks after standard RT and TMZ, and every 8 weeks during adjuvant TMZ. Since this is a study in newly diagnosed patients with HGG, the baseline imaging will be designated as the imaging obtained 2 to 4 weeks after the completion of standard RT and TMZ. At each time point, based on RANO criteria, the subject response will be characterized as Complete Response, Partial Response, Progressive Disease, Stable Disease, or Not Evaluable.
- Protection of Bone Marrow against Chemotherapy-Induced Thrombocytopenia [ Time Frame: 1 year ]Platelet counts will be assessed weekly during the 8 weeks of primary therapy involving BMX-001. Up to 50% of subjects receiving standard of care TMZ will develop thrombocytopenia after 3-5 weeks with platelet counts falling below 100,000 and about 15% will develop severe thrombocytopenia.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subjects must have histologically confirmed diagnosis of World Health Organization (WHO) grade III or IV malignant glioma
- Subjects must be planning to start standard of care radiation therapy and chemotherapy
- Subjects must be within 12 weeks of last major neurosurgical procedure for the high-grade glioma (craniotomy, open biopsy, or stereotactic biopsy)
- Subjects must have had a definitive resection with residual radiographic contrast enhancement on post-resection CT or MRI of less than or equal to 3 cm in any two perpendicular planes on any images
- Age * 18 years
- Karnofsky Performance Status (KPS) ≥ 70%
- Hemoglobin ≥ 9.0 g/dl, absolute neutrophil count (ANC) ≥ 1,500 cells/µl, platelets ≥ 125,000 cells/µl
- Serum creatinine ≤ 1.5 mg/dl, serum glutamate oxaloacetate transaminase (SGOT) and bilirubin ≤ 1.5 times upper limit of normal
- Signed informed consent approved by the Institutional Review Board
- If sexually active, patients must agree to use appropriate contraceptive measures for the duration of the study and for 12 months afterwards as stated in the informed consent
- Stable and/or decreasing dose of corticosteroids for greater than or equal to 7 days.
Exclusion Criteria:
- Pregnancy or breast-feeding
- Active infection requiring IV antibiotics 7 days before enrollment
- Signs of wound-healing problems or infection at the craniotomy/biopsy site.
- Prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin
- Co-medication that may interfere with study results; e.g. immuno-suppressive agents other than corticosteroids
- Prior treatment with radiotherapy or chemotherapy for a brain tumor, irrespective of the grade of the tumor
- Evidence of > grade 1 CNS hemorrhage on baseline MRI on CT scan
- Systemic treatment with inducers or strong inhibitors of cytochrome P450 within four days before enrollment or planned treatment during the time period of the study.
- Metal in the body (except dental fillings) e.g., pacemaker, infusion pump, metal aneurysm clip, metal prosthesis, joint, rod or plate.
- Severe allergy to contrast agent.
- Inadequately controlled hypertension
- Active or history of postural hypotension and autonomic dysfunction
- Clinically significant (i.e. active) cardiovascular disease or cerebrovascular disease, for example cerebrovascular accidents ≤ 6 months prior to study enrollment, myocardial infarction ≤ 6 months prior to study enrollment, unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure (CHF), or serious cardiac arrhythmia uncontrolled by medication or potentially interfering with protocol treatment
- History or evidence upon physical/neurological examination of central nervous system disease (e.g. seizures) unrelated to cancer unless adequately controlled by medication or potentially interfering with protocol treatment
- Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to start of study treatment
- A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >480 milliseconds (ms) (CTCAE grade 1)
- A known history of additional risk factors for Torsades de Pointes (TdP) (e.g., congestive heart failure, hypokalemia, known family history of Long QT Syndrome).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02655601
United States, Alabama | |
University of Alabama- Birmingham | |
Birmingham, Alabama, United States, 35294 | |
United States, California | |
University of California San Francisco | |
San Francisco, California, United States, 94143 | |
United States, Kentucky | |
University of Kentucky | |
Lexington, Kentucky, United States, 40536 | |
United States, Missouri | |
St. Luke's Hospital | |
Kansas City, Missouri, United States, 64111 | |
United States, Nebraska | |
University of Nebraska Medical Center | |
Omaha, Nebraska, United States, 68198 | |
United States, North Carolina | |
Duke Cancer Institute | |
Durham, North Carolina, United States, 27710 | |
United States, Ohio | |
Ohio State University | |
Columbus, Ohio, United States, 43210 | |
United States, Utah | |
Huntsman Cancer Institute | |
Salt Lake City, Utah, United States, 84112 | |
United States, Washington | |
University of Washington | |
Seattle, Washington, United States, 98195 |
Principal Investigator: | Katherine Peters, MD, PhD | Duke Cancer Institute |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | BioMimetix JV, LLC |
ClinicalTrials.gov Identifier: | NCT02655601 |
Other Study ID Numbers: |
BMX-HGG-001 |
First Posted: | January 14, 2016 Key Record Dates |
Last Update Posted: | July 13, 2022 |
Last Verified: | July 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Glioblastoma Glioma Astrocytoma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
Manganese Temozolomide Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Trace Elements Micronutrients Physiological Effects of Drugs |