Advertisement

Investigational New Drugs

, Volume 16, Issue 4, pp 331–332 | Cite as

Phase II study of Didemnin B in central nervous system tumors: A Southwest Oncology Group study

  • Sarah A. Taylor
  • Dorothy J. Giroux
  • Kurt A. Jaeckle
  • Timothy J. Panella
  • Shaker R. Dakhil
  • S. Clifford Schold
Article

Abstract

Didemnin B 6.3 mg/m2 was administered intravenously to 48 patients with recurrent or progressive central nervous system tumors. One patient of 39 (2.9%, 95% confidence limits 0.1 to 13.5) eligible patients had a confirmed partial response utilizing standard solid tumor criteria which lasted 14 months. Toxicity was significant. Nausea and vomiting and lethargy were the most frequent toxicities, but multiple severe toxicities were seen. Further investigation of Didemnin B at this dose is not warranted in patients with central nervous system malignancies.

central nervous system tumors Didemnin B 

References

  1. 1.
    Annual Report to the Food and Drug Administration on Didemnin B (NSC-3253219, IND-245055), August 1996Google Scholar
  2. 2.
    Dorr FA, Kuhn JG, Phillips J, Von Hoff DD: Phase I clinical and pharmacokinetic investigation of Didemnin B, a cyclic depsipeptide. J Cancer Clin Oncol 24: 1699–1706, 1988CrossRefGoogle Scholar
  3. 3.
    Stewart JA, Low JB, Roberts JD, Blow A: A phase I clinical trial of Didemnin B. Cancer 68: 2550–2554, 1991PubMedGoogle Scholar

Copyright information

© Kluwer Academic Publishers 1998

Authors and Affiliations

  • Sarah A. Taylor
    • 1
  • Dorothy J. Giroux
    • 2
  • Kurt A. Jaeckle
    • 3
  • Timothy J. Panella
    • 4
  • Shaker R. Dakhil
    • 5
  • S. Clifford Schold
    • 6
  1. 1.University of Kansas Medical CenterKansas City
  2. 2.Southwest Oncology Group Statistical CenterSeattle
  3. 3.University of Utah Medical CenterSalt Lake City
  4. 4.Thompson Cancer Survival CenterKnoxville
  5. 5.Wichita CCOPWichita
  6. 6.University of Texas SouthwesternDallasUSA

Personalised recommendations