Tamoxifen Versus Etoposide After First Recurrence in GBM Patients

NCT04765098 | Recruiting Phase 2 DMC

• 1 other identifier: IIT-0014
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The investigator propose a single-center randomized phase II controlled study designed to compare the management of first recurrence of GBM using etoposide versus tamoxifen.

Conditions

Glioblastoma Multiforme

Outcome Measures

Primary Outcomes (1)

• 3 month progression-free survival

  Time between randomization and radiographic or clinical progression leading to change in therapy for recurrent disease or death due to any cause.

  3 months

Secondary Outcomes (4)

• One-year progression-free survival

  12 months

• Overall survival

  Median, 6-month, 1-year, and 2-year OS rates will be measured

• Health-related quality-of-life status

  Throughout study completion, up to 5 years.

• Adverse events

  Throughout the whole duration of the trial, up to 5 years

Study Arms (2)

Etoposide

ACTIVE COMPARATOR

Drug: Etoposide

Tamoxifen

EXPERIMENTAL

Drug: Tamoxifen

Interventions

Tamoxifen DRUG

Tamoxifen 20 mg daily for 3 days then 20 mg BID for 3 days then increase by 20 mg daily every 3 days until 100 mg BID continuously

Tamoxifen

Etoposide DRUG

etoposide 50mg/m2 daily

Etoposide

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven GBM with progression after previous first line chemoradiotherapy with temozolomide.
• Progression documented by MRI with at least one bi-dimensionally measurable target lesion with one diameter of at least 10 mm, visible on two or more axial slices 5 mm apart.
• Not received radiotherapy within the three months before the diagnosis of progression.
• Stable or decreasing dose of corticosteroids prior to randomization: corticosteroids (dexamethasone) should be given at the lowest dose needed to control symptoms arising from increased intracerebral edema.
• ECOG performance 0-2 (Appendix 2).
• Age from 18-65 years.
• Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test within 72 hours prior to the first dose of study treatment. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes.
• Patients of childbearing / reproductive potential should use adequate birth control methods, as defined by the investigator, during the study treatment period and for a period of 60 days after the last dose of study drug. A highly effective method of birth control is defined as those that result in low failure rate (i.e. less than 1% per year) when used consistently and correctly.
• Note: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard.
• Laboratory evaluation obtained within 7 days prior to randomization, with adequate function as defined below:
• ANC ≥ 1.5 x 109/L
• Platelets ≥ 100 x 109/L
• Serum creatinine ≤ 1.5 times ULN
• Total serum bilirubin ≤ 1.5 times ULN
• ALT \< 3 times ULN

You may not qualify if:

• History of another malignancy or a concurrent malignancy (exceptions include patients who have been disease-free for 3 years, or patients with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible, for example cervical cancer in situ.
• Uncontrolled hypertension (systolic blood pressure \>150 mm Hg or diastolic blood pressure \>100 mm Hg).
• Any arterial or venous thrombosis up to 6 months before registration.
• Evidence of recent hemorrhage on brain MRI.
• Substantial cardiovascular disease: cerebral vascular accident/stroke (\<6 months prior to enrollment), myocardial infarction (\<6 months prior to enrollment), unstable angina, congestive heart failure (\> New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, Canada

RECRUITING

MeSH Terms

Conditions

Glioblastoma

Interventions

Tamoxifen; Etoposide

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Central Study Contacts

Jacob Easaw, MD, PhD, FRCPC

CONTACT

780-432-8290; jay.easaw@ahs.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: February 21, 2021
• Study Start: January 28, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 26, 2025

Record last verified: 2025-06

Locations

CA (1)