A Study of Maprotiline in Combination With Tamoxifen and Temozolomide for Recurrent Glioblastoma
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|ClinicalTrials.gov Identifier: NCT04200066|
Recruitment Status : Not yet recruiting
First Posted : December 16, 2019
Last Update Posted : December 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Brain Tumor||Drug: Temozolomide, Tamoxifen, Maprotiline||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study of Maprotiline in Combination With Tamoxifen and Temozolomide for Recurrent Glioblastoma|
|Estimated Study Start Date :||February 1, 2020|
|Estimated Primary Completion Date :||February 1, 2023|
|Estimated Study Completion Date :||June 1, 2023|
Experimental: Experimental Arm
This arm will combine maprotiline with temozolomide and tamoxifen to determine the maximum tolerated dose.
Drug: Temozolomide, Tamoxifen, Maprotiline
Subjects will receive a combination of temozolomide and tamoxifen for two weeks. After that, they will receive a combination of temozolomide, tamoxifen and maprotiline for the remainder of the study. All drugs are administered orally. Subjects will undergo visits at the beginning of week 3, week 5 and week 7 that will involve multiple blood draws and ECGs to evaluate for pharmacokinetics and drug interactions. Response will be assessed every two months with an MRI and patients will continue on study as long as their tumors are under control and they are tolerating the regimen.
- Maximum Tolerated Dosing Regimen (MTDR) of maprotiline in combination with temozolomide (TMZ) and tamoxifen (TMX) [ Time Frame: through study completion, an average of 6 months ]Assessment of toxicity based on the NCI common toxicity criteria.
- Mean Maprotiline drug level [ Time Frame: week 7 ]Blood sampling for pharmacokinetic assessment of study drugs. The mean maprotiline drug level will be reported. The drug levels will be measured at 2, 5, and 7 hours on weeks 1, 2, 3, 5 and 7
- Median Maprotiline drug level [ Time Frame: week 7 ]Blood sampling for pharmacokinetic assessment of study drugs. The median maprotiline drug level will be reported. The drug levels will be measured at 2, 5, and 7 hours on weeks 1, 2, 3, 5 and 7
- 6 mo Progression Free Survival [ Time Frame: 6 months ]
Measure of time from study enrollment until progression.
Progressive Disease: >25% increase in the bi-dimensional area OR an increase in T2/FLAIR abnormality that is consistent with tumor OR the presence of a new lesion OR clinical deterioration.
- Overall Survival [ Time Frame: from date of enrollment until date of death from any cause up to 60 months ]Measure of time from study enrollment until death from any cause.
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): NCT04200066
|Contact: Nimish Mohile, MD||585-275-5863||Nimish_Mohile@URMC.rochester.edu|
|Contact: Jennifer Serventi, NP||Jennifer_Serventi@URMC.rochester.edu|
|Principal Investigator:||Nimish Mohile, MD||University of Rochester|