A Trial for Treatment of Cancer Patients With Multiple Brain Metastases Undergoing Whole-Brain Radiotherapy
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|ClinicalTrials.gov Identifier: NCT03608020|
Recruitment Status : Recruiting
First Posted : July 31, 2018
Last Update Posted : September 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Multiple Brain Metastases||Drug: BMX-001 Radiation: Whole Brain Radiation Therapy||Phase 1 Phase 2|
This protocol is for a Phase 1 safety lead-in clinical trial of BMX-001 in combination with WBRT in 5 patients with MBM. Demonstrating safety of the selected MTD of BMX-001 in patients with MBM undergoing standard protocol WBRT will be the "go/no-go" criteria for proceeding to Phase 2.
Phase 2 is a randomized open-label Phase 2 clinical trial of 64 patients with MBM, half receiving BMX-001 in combination with WBRT and half receiving WBRT alone.
Subjects are treated with BMX-001 for a total of 19 days, during which time they receive radiation therapy. Following completion of radiation therapy, subjects will be followed for an additional one year.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||69 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Safety Lead-In/Randomized Phase 2 Study of BMX-001 as a Therapeutic Agent for Treatment of Cancer Patients With Multiple Brain Metastases Undergoing Whole-Brain Radiotherapy|
|Actual Study Start Date :||October 4, 2018|
|Estimated Primary Completion Date :||August 31, 2022|
|Estimated Study Completion Date :||September 30, 2022|
Active Comparator: WBRT + BMX-001
Whole brain radiation therapy in combination with BMX-001 (subcutaneous injection of 28 mg loading dose, followed by subsequent 14 mg twice per week for 2 weeks).
Manganese butoxyethyl pyridyl porphyrin
Other Name: Whole Brain Radiation Therapy
Radiation: Whole Brain Radiation Therapy
Whole Brain Radiation Therapy per standard of care.
No Intervention: Whole Brain Radiation Therapy
Whole brain radiation therapy per standard of care.
- Assess safety and tolerability of WBRT + BMX-001 through proportion of patients who experience grade 4 or 5 study drug related adverse events. [ Time Frame: 1 year ]
AEs will be assessed according to the CTCAE version 5.0. If CTCAE grading does not exist for an AE, the severity of the AE will be graded as mild (1), moderate (2), severe (3), life-threatening (4), or fatal (5). Initially 5 patients will be accrued and treated with WBRT + BMX-001 as a lead-in safety phase. Enrollment to the randomized phase of the study will not proceed if patients in the safety lead-in phase experience the following:
- Two or more patients are unable to complete radiation therapy (RT) due to toxicity related to BMX-001 (alone or in combination with RT.
- Two or more patients experience delay in starting RT due to toxicity related to BMX-001 (alone or in combination with RT).
If any patient experiences a grade 4 or 5 BMX-001-related adverse event within Arm A (WBRT + BMX-001), accrual will be suspended and the experience of the patient will be carefully reviewed by the clinical team and the study's DSMB.
- Compare neurocognition in WBRT + BMX-001 vs. WBRT alone using cumulative score of HVLT-R, TMT A&B and COWA over time. [ Time Frame: 1 Year ]Subjects will complete three standardized tests (Hopkins Verbal Learning Test - Revised, Trail Making Test A&B, and Controlled Oral Word Association test) at baseline, 1 month after completion of WBRT and every 3 months after completion of WBRT. The cumulative score of these three tests will be used to assess change.
- Compare survival in WBRT + BMX-001 vs WBRT alone [ Time Frame: 1 Year ]Survival
- Compare local recurrence rate in WBRT + BMX-001 vs WBRT alone [ Time Frame: 1 Year ]Median time to local brain failure or progression
- Compare distant brain failure rate in WBRT + BMX-001 vs WBRT alone [ Time Frame: 1 Year ]Median time to distant brain failure
- Compare rate of neurologic death in WBRT + BMX-001 vs WBRT alone [ Time Frame: 1 Year ]Proportion of patients who are dead within 1 year of initiation of WBRT due to neurologic disease and/or disseminated leptomeningeal carcinomatosis.
- Compare rate of radionecrosis in WBRT + BMX-001 vs WBRT alone [ Time Frame: 1 Year ]Proportion of patients with enlarged and/or symptomatic brain lesions with no viable tumor on biopsy
- Compare QoL in WBRT + BMX-001 vs WBRT alone [ Time Frame: 1 Year ]Mean change from baseline at each follow-up assessment
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): NCT03608020
|Contact: Sara Penchevemail@example.com|
|United States, North Carolina|
|Duke Cancer Institute||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Heather Franklin, RN firstname.lastname@example.org|
|Principal Investigator: John Kirkpatrick, MD|
|Principal Investigator:||John Kirkpatrick, MD||Duke Cancer Institute|