Symptoms and General Pathology

All Conditions

Neoplasms

Nervous System Diseases

Rare Diseases

Recurrence

Glioblastoma

Brain Neoplasms

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Bone Density Conservation Agents

Antineoplastic Agents

All Drugs and Chemicals

Psychotropic Drugs

Tamoxifen

Temozolomide

Maprotiline

Antineoplastic Agents, Alkylating

Alkylating Agents

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Estrogen Receptor Modulators

Selective Estrogen Receptor Modulators

Antidepressive Agents

Adrenergic Agents

Neurotransmitter Agents

This arm will combine maprotiline with temozolomide and tamoxifen to determine the maximum tolerated dose.

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.

Temozolomide, Tamoxifen, Maprotiline

Nimish Mohile, MD

The main purpose of this study is to find out the highest possible dose of maprotiline that can be given safely in combination with temozolomide and tamoxifen.

The main purpose of this study is to find out the highest possible dose of maprotiline that can be given safely in combination with temozolomide and tamoxifen. Temozolomide is approved to treat glioblastoma and the investigator wants to understand what doses are safe to use. Tamoxifen has been used for many years to treat breast cancer and there have also been studies combining it with temozolomide for the treatment of brain tumors that have shown the combination to be safe. In this study, the investigator will be adding maprotiline to temozolomide and tamoxifen, determining the highest possible dose that is safe, making sure there are no significant drug interactions and studying the safety of this combination.

A Study of Maprotiline in Combination With Tamoxifen and Temozolomide for Recurrent Glioblastoma

A Phase 1 Study of Maprotiline in Combination With Tamoxifen and Temozolomide for Recurrent Glioblastoma

Assessment of toxicity based on the NCI common toxicity criteria.

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

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

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.

Measure of time from study enrollment until death from any cause.

University of Rochester

Associate Professor of Neurology

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of Maprotiline in Combination With Tamoxifen and Temozolomide for Recurrent Glioblastoma	NCT04200066	Glioblastoma Brain Tumor	Temozolomide, T...	18 Years -	University of Rochester
A Study of Maprotiline in Combination With Tamoxifen and Temozolomide for Recurrent Glioblastoma	NCT04200066	Glioblastoma Brain Tumor	Temozolomide, T...	18 Years -	University of Rochester

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