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A phase I, dose-escalation study of cyclical weekly oral temozolomide and weekly PEG-interferon alpha-2b in patients with refractory or advanced solid tumours.

AbstractBACKGROUND:
Temozolomide (TMZ) is an oral alkylating agent used in the treatment of central nervous system neoplasms and metastatic melanoma. Preclinical and clinical data suggested that combining TMZ with interferon alpha-2b (IFN-alpha-2b) may result in increased anti-tumour efficacy.
METHODS:
This was a phase I, dose-escalation study to define the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of cyclical oral TMZ (days 1-7 and 15-21) in combination with pegylated IFN-alpha-2b (PEG-IFN-alpha-2b) in patients with advanced solid tumours.
RESULTS:
We treated 19 patients (10 female and nine male), median age 58 years (range: 41-79 years). Ten patients tolerated TMZ at 100 mg/m² on days 1-7 and 15-21 plus PEG-IFN-alpha-2b at 1.5 mcg/kg/week on 28-day cycles which was the MTD of the combination. The pharmacokinetic parameters of PEG-IFN-alpha-2b were not altered by TMZ, at the MTD.
CONCLUSION:
The MTD of cyclical oral TMZ was 100 mg/m² on days 1-7 and 15-21 when combined with weekly subcutaneous PEG-IFNα-2b at 1.5 mcg/kg/week on 28 days cycles. The PK of PEG-IFN-alpha-2b appeared consistent with those when it is used as monotherapy.
AuthorsShodeinde A Coker, Uday B Dandamudi, Andrew P Beelen, Nancy A Crosby, Jan L Fisher, Michael Obrocea, Marc S Ernstoff, Lionel D Lewis
JournalJournal of chemotherapy (Florence, Italy) (J Chemother) Vol. 25 Issue 6 Pg. 362-8 (Dec 2013) ISSN: 1973-9478 [Electronic] England
PMID24093213 (Publication Type: Clinical Trial, Phase I, Journal Article)
Chemical References
  • Interferon alpha-2
  • Interferon-alpha
  • Recombinant Proteins
  • Polyethylene Glycols
  • Dacarbazine
  • peginterferon alfa-2b
  • Temozolomide
Topics
  • Administration, Oral
  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols (adverse effects, pharmacokinetics, therapeutic use)
  • Dacarbazine (administration & dosage, adverse effects, analogs & derivatives, pharmacokinetics)
  • Female
  • Humans
  • Interferon alpha-2
  • Interferon-alpha (administration & dosage, adverse effects, pharmacokinetics)
  • Male
  • Maximum Tolerated Dose
  • Middle Aged
  • Neoplasms (drug therapy)
  • Polyethylene Glycols (administration & dosage, adverse effects, pharmacokinetics)
  • Recombinant Proteins (administration & dosage, adverse effects, pharmacokinetics)
  • Temozolomide
  • Treatment Outcome

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