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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04765098
Other study ID # IIT-0014
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date January 28, 2022
Est. completion date December 2026

Study information

Verified date June 2024
Source AHS Cancer Control Alberta
Contact Jacob Easaw, MD, PhD, FRCPC
Phone 780-432-8290
Email jay.easaw@ahs.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 2026
Est. primary completion date August 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: 1. Histologically proven GBM with progression after previous first line chemoradiotherapy with temozolomide. 2. 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. 3. Not received radiotherapy within the three months before the diagnosis of progression. 4. 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. 5. ECOG performance 0-2 (Appendix 2). 6. Age from 18-65 years. 7. 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. 8. 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. 9. 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 - AST < 3 times ULN - Alkaline phosphatase < 3 times ULN 10. Patient must understand and sign an informed consent prior to study registration. Exclusion Criteria: 1. 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. 2. Uncontrolled hypertension (systolic blood pressure >150 mm Hg or diastolic blood pressure >100 mm Hg). 3. Any arterial or venous thrombosis up to 6 months before registration. 4. Evidence of recent hemorrhage on brain MRI. 5. 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tamoxifen
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
Etoposide
etoposide 50mg/m2 daily

Locations

Country Name City State
Canada Cross Cancer Institute Edmonton Alberta

Sponsors (1)

Lead Sponsor Collaborator
AHS Cancer Control Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 One-year 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. 12 months
Secondary Overall survival Time between randomization and death due to any cause. Patients without an event will be censored the last time they were known to be alive. Median, 6-month, 1-year, and 2-year OS rates will be measured
Secondary Health-related quality-of-life status Health-related quality-of-life will be assessed using the EORTC QLQ-BN20 brain tumor module questionnaire. This is a self-report questionnaire consisting of 20 items that assess future uncertainty, visual disorder, motor dysfunction, and communication deficit in brain tumor patients Throughout study completion, up to 5 years.
Secondary Adverse events This includes fatigue, hematologic toxicities (neutropenia, thrombocytopenia, leukopenia, anemia), liver toxicities, hypertension, diarrhea, seizures and thrombosis and will all be recorded. Throughout the whole duration of the trial, up to 5 years
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