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Not Yet RecruitingPhase 1ACTRN12612001050842

Valproic acid and Metformin to treat patients with brain tumours

Valproate and MetformIn in GlioBlastoma multiformE Study: A single-arm trial to assess safety and feasibility – VIBE 1

Sponsor

Flinders Centre for Innovation in Cancer, Flinders University/Flinders Medical centre

Enrollment

12 participants

Start Date

Jan 1, 2013

Study Type

Interventional

Conditions

Brain tumours - Glioblastoma multiforme (GBM)

Summary

This study is looking at the safety of adding valproate and metformin to standard therapy used to treat patients with brain tumours called as glioblastoma multiforme (GBM) or grade 4 glioma. Who is it for? You maybe eligible to join this study if you are aged 18 years or above, and have been newly diagnosed with grade 4 glioma or glioblastoma multiforme. You should have had a surgical resection/biopsy within the previous 7 weeks. Trial details: All participants undergo standard treatment with temozolomide and radiotherapy followed by 6 months of temozolomide. In addition to standard care, all participants will receive Valproic acid (upto 4000 milligrams per day mg orally and metformin upto 2000 milligrams per day administered orally. Participants will be regularly assessed for up to 12 months in order to determine treatment response, tolerability and safety.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria15

  • Newly diagnosed supratentorial GBM (histopathologically confirmed as WHO Grade IV, including GBM subtypes, e.g. gliosarcoma)
  • Males or females older than or equal to 18 years of age.
  • Able to provide written informed consent
  • Stable or decreasing dose of steroids for >5 days prior to randomization.
  • ECOG PS - 0 or 1.
  • Interval of greater than 1 week but less than 7 weeks after surgery or biopsy before first administration of study treatment.
  • Laboratory values (within 2 week prior to randomization):
  • 1. Absolute neutrophil count greater than 1500/mm3.
  • 2. Platelet count greater than 100,000/mm3.
  • 3. Creatinine clearance rate greater than 60 mL/min
  • 4. Prothrombin time (PT) international normalized ratio (INR) within normal limits and partial thromboplastin time (PTT) below the upper limit of normal.
  • 5. Haemoglobin greater than 10 g/dL.
  • 6. Total bilirubin greater than 1.5 x the ULN.
  • 7. AST & ALT greater than 2.5 x ULN
  • 8. Alkaline phosphatase greater than 2.5 x ULN.

Exclusion Criteria17

  • Cytotoxic chemotherapy within the prior 5 years
  • Prior XRT of the head (except for low dose radiotherapy for tinea capitis)
  • Receiving concurrent investigational agents or has received an investigational agent(s) within the past 30 days
  • Prior/current use of metformin or sodium valproate
  • Placement of Gliadel (registered trademark) wafer at surgery.
  • Treatment with a prohibited concomitant medication
  • Planned major surgery for other diseases
  • History of malignancy. Subjects with curatively treated cervical carcinoma in situ or basal cell carcinoma of the skin, or subjects who have been free of other malignancies for more than 5 years are eligible for this study.
  • History of coagulation disorder associated with bleeding or recurrent thromboembolic events.
  • Clinically manifest myocardial insufficiency (NYHA III, IV) or history of myocardial infarction during the past 6 months; uncontrolled arterial hypertension.
  • Concurrent illness, including severe infection,(eg HIV) which may jeopardize the ability of the subject to receive the procedures outlined in this protocol with reasonable safety.
  • Subject is pregnant (positive serum beta human chorionic gonadotropin [beta-HCG] test at screening) or is currently breast-feeding,or has the potential and wishes to becoming pregnant/ impregnate their partner during the study or within 6 months after study participation, or subject does not agree to follow acceptable methods of birth control, such as hormonal contraception, intra-uterine pessary, condoms or sterilization, to avoid conception during the study and for at least 6 months after receiving the last dose of study treatment.
  • Current alcohol dependence or drug abuse.
  • Known hypersensitivity to the study treatment.
  • Unable to adhere to the study protocol or follow-up schedule.
  • Signs and symptoms suggestive of transmissible spongiform encephalopathy, or a family members who suffer(ed) from spongiform encephalopathy.
  • No previous exposure to ALA Fluorescent dye peri operatively

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Interventions

Valproic acid and metformin added to standard therapy (Temozolomide/radiotherapy) Valproic acid: oral - 200 mg twice daily to a maximum of 60 mg/day; dose adjusted based on plasma levels; maximum of

Valproic acid and metformin added to standard therapy (Temozolomide/radiotherapy) Valproic acid: oral - 200 mg twice daily to a maximum of 60 mg/day; dose adjusted based on plasma levels; maximum of 10 months Metformin: oral titrated upto 2 gm per day; maximum of 10 months

Locations(1)

SA, Australia

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ACTRN12612001050842