A phase II trial of bryostatin-1 in patients with metastatic or recurrent squamous cell carcinoma of the head and neck Journal Article


Authors: Pfister, D. G.; McCaffrey, J.; Zahalsky, A. J.; Schwartz, G. K.; Lis, E.; Gerald, W.; Huvos, A.; Shah, J.; Kraus, D.; Shaha, A.; Singh, B.; Wolden, S.; Zelefsky, M.; Palgi, I.
Article Title: A phase II trial of bryostatin-1 in patients with metastatic or recurrent squamous cell carcinoma of the head and neck
Abstract: Bryostatin-1 is a macrocyclic lactone that has been shown to modulate Protein Kinase C activity and has demonstrated antitumor activity in vitro and in vivo. Fifteen patients with metastatic or recurrent squamous cell carcinoma of the head and neck were treated with bryostatin-1 at a dose of 25 mcg/m2 by continuous intravenous infusion over 24 hours once weekly for three weeks followed by a break week to complete a four-week cycle. There were no major objective responses in the 14 evaluable patients. One patient with nasopharynx cancer had disease stabilization for 4 months prior to being removed from the study due to medical issues. This clinical benefit corresponded to a radiographic decrease in metabolic activity on positron emission tomograpy (PET) scan as well as molecular evidence of tumor apoptosis in a poly[ADP-ribose] polymerase (PARP) cleavage assay. Bryostatin-1 is not recommended for use as a single agent for the treatment of squamous cell head and neck cancer. Further investigation is warranted to determine the strength of the correlation between bryostatin-1 activity and PARP cleavage as a surrogate molecular marker of apoptosis.
Keywords: adult; clinical article; aged; middle aged; clinical trial; squamous cell carcinoma; carcinoma, squamous cell; antineoplastic agents; positron emission tomography; recurrent cancer; metastasis; apoptosis; phase 2 clinical trial; neoplasm recurrence, local; gastrointestinal symptom; antineoplastic activity; enzyme activity; head and neck cancer; head and neck neoplasms; protein kinase c; nasopharynx cancer; bryostatin 1; nicotinamide adenine dinucleotide adenosine diphosphate ribosyltransferase; infusions, intravenous; head and neck carcinoma; lactones; macrolides; bryostatin-1; humans; human; male; female; priority journal; article
Journal Title: Investigational New Drugs
Volume: 20
Issue: 1
ISSN: 0167-6997
Publisher: Springer  
Date Published: 2002-02-01
Start Page: 123
End Page: 127
Language: English
DOI: 10.1023/a:1014449309165
PUBMED: 12003188
PROVIDER: scopus
DOI/URL:
Notes: Export Date: 14 November 2014 -- Source: Scopus
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MSK Authors
  1. Michael J Zelefsky
    651 Zelefsky
  2. Gary Schwartz
    372 Schwartz
  3. Dennis Kraus
    263 Kraus
  4. Ashok R Shaha
    550 Shaha
  5. Eric Lis
    108 Lis
  6. Bhuvanesh Singh
    210 Singh
  7. Suzanne L Wolden
    432 Wolden
  8. William L Gerald
    374 Gerald
  9. David G Pfister
    263 Pfister
  10. Jatin P Shah
    562 Shah
  11. Andrew G Huvos
    228 Huvos
  12. Ilana   Palgi
    1 Palgi