Symptoms and General Pathology

All Conditions

Neoplasms

Rare Diseases

Recurrence

Glioblastoma

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

Antineoplastic Agents

All Drugs and Chemicals

Psychotropic Drugs

Lomustine

Imipramine

Antineoplastic Agents, Alkylating

Alkylating Agents

Antidepressive Agents

Antidepressive Agents, Tricyclic

Adrenergic Agents

Neurotransmitter Agents

For surgical cohort patients, lomustine will be initiated (C1D1) within 6 weeks of surgery as soon as patient is deemed by the investigator (or designee) to be recovered enough for chemotherapy. Initiation of lomustine must be initiated within 6 weeks. If patient cannot be safely initiated on lomustine within this timeframe then they will be replaced.

For non-surgical cohort patients (the decision for surgery is made independent of study participation), lomustine will be initiated on C1D1.

For both cohorts, lomustine will be administered as 110 mg/m2 PO once every 6 weeks.

For the surgical cohort, imipramine hydrochloride will be initiated within a minimum of 16 days to a maximum of 3 weeks prior to surgery. Imipramine hydrochloride will be administered as 50mg PO (oral) QHS (at bedtime) for 4 days followed by a dose increase (taper-up) of 50mg/day every fourth day to attain a maximum dose of 200mg/day in 16 days.

For non-surgical cohort patients (the decision for surgery is made independent of study participation), imipramine hydrochloride will be initiated on Cycle 1 Day 1. Imipramine hydrochloride will be administered as 50mg PO (oral) QHS (at bedtime) for 4 days followed by a dose increase (taper-up) of 50mg/day every fourth day, if tolerated, to attain a maximum dose of 200mg/day in 16 days.

Imipramine Hydrochloride

Epp Goodwin

Maggie Tomasini

William Kelly, MD

This study is designed as a single center, prospective, open label, single-arm therapeutic trial with both surgical and non-surgical cohorts.

Investigator-Initiated Study of Imipramine Hydrochloride and Lomustine in Recurrent Glioblastoma

A Phase II, Investigator-Initiated Study of Imipramine Hydrochloride and Lomustine in Recurrent Glioblastoma

The University of Texas Health Science Center at San Antonio

Clinical Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Investigator-Initiated Study of Imipramine Hydrochloride and Lomustine in Recurrent Glioblastoma	NCT04863950	Glioblastoma	Lomustine Imipramine Hydr...	-	The University of Texas Health Science Center at San Antonio
Investigator-Initiated Study of Imipramine Hydrochloride and Lomustine in Recurrent Glioblastoma	NCT04863950	Glioblastoma	Lomustine Imipramine Hydr...	-	The University of Texas Health Science Center at San Antonio

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