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Gd-Tex Pharmacyclics Inc.

I R Radford1

  • 1Peter MacCallum Cancer Institute, Melbourne, Victoria 8006, Australia. i.radford@pmci.unimelb.edu.au

Current Opinion in Investigational Drugs (London, England : 2000)
|March 16, 2001
PubMed
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Gd-Tex (gadolinium texaphyrin) shows promise as a radiosensitizer for various cancers. Clinical trials indicate significant tumor response rates and improved survival in patients with brain metastases, with manageable side effects.

Area of Science:

  • Oncology
  • Radiotherapy
  • Pharmacology

Background:

  • Gd-Tex (gadolinium texaphyrin) is a novel radiosensitizer developed by Pharmacyclics.
  • It is being investigated for the treatment of various solid tumors, including brain metastases, pancreatic cancer, lung cancer, and pediatric cancers.
  • The compound has advanced to Phase III clinical trials for brain metastases.

Purpose of the Study:

  • To evaluate the efficacy and safety of Gd-Tex as a radiosensitizer in multiple cancer types.
  • To determine optimal dosing regimens and administration schedules for Gd-Tex in combination with radiotherapy.
  • To assess the selective accumulation of Gd-Tex in tumor tissues.

Main Methods:

  • Multiple Phase I, Ib/II, and Phase III clinical trials were conducted across various cancer types.

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  • Gd-Tex was administered in conjunction with different radiotherapy protocols, including whole brain radiation and stereotactic radiosurgery.
  • Tumor response was assessed using objective measures like tumor volume reduction and MRI, and safety was monitored through adverse event reporting.

    • Main Results:

    • A Phase Ib/II trial for brain metastases showed a 73% overall tumor response rate, with 77.7% of patients demonstrating a >50% tumor volume reduction after treatment.
    • Gd-Tex was well-tolerated, with reversible liver enzyme elevation as the dose-limiting toxicity.
    • The Gd-Tex group experienced a lower rate of death due to tumor progression (15%) compared to the control group (35%).

    Conclusions:

    • Gd-Tex demonstrates significant radiosensitizing potential, leading to substantial tumor response and improved survival in patients with brain metastases.
    • The compound is generally well-tolerated, with manageable side effects.
    • Further clinical trials are ongoing to establish Gd-Tex as a viable treatment option for various cancers.