Comparing Tamoxifen and Etoposide for Glioblastoma Recurrence

A Randomized Controlled Trial of Tamoxifen Versus Etoposide for Patients With First Recurrence of Glioblastoma Multiforme

This study is testing whether tamoxifen or etoposide is more effective for people whose glioblastoma has come back after initial treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: AHS Cancer Control Alberta (Academic / other)
• Locations: 1 site (Edmonton, Alberta)
• Trial ID: NCT04765098 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the effectiveness of two medications, tamoxifen and etoposide, in managing the first recurrence of glioblastoma multiforme (GBM) after initial treatment. It is a single-center, randomized phase II controlled study that will enroll patients who have histologically confirmed GBM and have shown progression after first-line chemoradiotherapy. Participants will be monitored for their response to either treatment, with the goal of determining which drug offers better outcomes for patients experiencing recurrence.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-65 with histologically proven GBM who have experienced progression after initial treatment with temozolomide.

Not a fit: Patients who have received radiotherapy within three months prior to progression or those with an ECOG performance status greater than 2 may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients with recurrent glioblastoma, potentially improving survival rates.

How similar studies have performed: While there have been various studies on treatments for GBM, the specific comparison of tamoxifen and etoposide in this context is relatively novel.

Eligibility criteria

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.

Where this trial is running

Edmonton, Alberta

• Cross Cancer Institute — Edmonton, Alberta, Canada (Recruiting)

Study contacts

• Study coordinator: Jacob Easaw, MD, PhD, FRCPC

Conditions Glioblastoma Multiforme