Glioblastoma Multiforme Clinical Trial
Official title:
A Phase III Multicenter Study of Intratumoral/Interstitial Therapy With TransMID™ Compared to Best Standard of Care in Patients With Progressive and/or Recurrent, Non-Resectable Glioblastoma Multiforme
TransMID treatment or best standard of care for patients with advanced glioblastoma
multiforme
Glioblastoma multiforme (GBM) is a type of brain tumour. GBM tumours are usually treated
with surgery and radiotherapy. Unfortunately, this type of brain tumour may continue to grow
or come back (recur) despite treatment.
This trial will compare a new drug called TransMID with the best standard treatment that is
currently available. TransMID is a drug that is a combination of a protein called
transferrin and a poison called diphtheria toxin.
Cancer cells need iron in order to continue to grow. They need more iron than normal cells.
Transferrin helps cells to take up available iron. So the cancer cells are attached to the
transferrin in TransMID, and the diphtheria poison kills them. The aim of this treatment is
to kill the cancer cells while not affecting the normal brain cells. This treatment for
brain tumours may have fewer side effects than other treatments because it targets cancer
cells.
The best standard treatment will involve giving chemotherapy. You may have chemotherapy as
part of the treatment when you are diagnosed. Or it may be kept in reserve to treat your
brain tumour if it comes back or continues to grow. Your cancer specialist (consultant) will
decide which chemotherapy drugs you should have.
This is a Multicenter, open label, randomized study comparing TransMID™ with a
chemotherapeutic regimen considered to be best standard of care and consisting of either
nitrosoureas, platinum compounds, temozolomide, procarbazine, PCV, (procarbazine, lomustine
(CCNU) & vincristine), CPT-11, or Etoposide. A planned interim analysis of the primary
efficacy endpoint will be conducted after approximately 50% of the required events have been
observed.
In order for a patient to be eligible for enrollment into this trial, he/she must be
diagnosed with glioblastoma multiforme which has been confirmed histologically and have
undergone conventional treatment, including surgery (biopsy or debulking) and/or radiation
therapy and/or chemotherapy, have a recurrent and/or progressive tumor ≥1.0 cm and ≤4.0 cm
in diameter.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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