Phase I trial of temozolomide (CCRG 81045: M&B 39831: NSC 362856)
1992

Phase I Trial of Temozolomide

Sample size: 51 publication Evidence: moderate

Author Information

Author(s): E.S. Newlands, G.R.P. Blackledge, J.A. Slack, G.J.S. Rustin, D.B. Smith, N.S.A. Stuart, C.P. Quarterman, R. Hoffman, M.F.G. Stevens, M.H. Brampton, A.C. Gibson

Primary Institution: Charing Cross Hospital

Hypothesis

Does temozolomide exhibit effective anti-tumor activity with manageable toxicity in patients with advanced cancer?

Conclusion

Temozolomide shows clinical activity in melanoma and gliomas with manageable side effects.

Supporting Evidence

  • Temozolomide was administered to 51 patients with advanced cancer.
  • Clinical activity was observed in melanoma and gliomas.
  • The recommended dose for Phase II trials is 150 mg/m2 for 5 days.
  • Patients tolerated the drug well with manageable side effects.
  • Responses included complete and partial responses in melanoma and mycosis fungoides.

Takeaway

Temozolomide is a new cancer drug that can help some patients with melanoma and brain tumors, and it's easier to take than older drugs.

Methodology

Patients with advanced cancer were given temozolomide in escalating doses, both intravenously and orally, to assess safety and effectiveness.

Limitations

The study was limited by the small sample size and the focus on specific cancer types.

Participant Demographics

Patients had advanced cancer refractory to standard therapy, with a mean age of 52 years.

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