Abstract | BACKGROUND: 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.
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Authors | Shodeinde A Coker, Uday B Dandamudi, Andrew P Beelen, Nancy A Crosby, Jan L Fisher, Michael Obrocea, Marc S Ernstoff, Lionel D Lewis |
Journal | Journal of chemotherapy (Florence, Italy)
(J Chemother)
Vol. 25
Issue 6
Pg. 362-8
(Dec 2013)
ISSN: 1973-9478 [Electronic] England |
PMID | 24093213
(Publication Type: Clinical Trial, Phase I, Journal Article)
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Chemical References |
- Interferon alpha-2
- Interferon-alpha
- Recombinant Proteins
- Polyethylene Glycols
- Dacarbazine
- peginterferon alfa-2b
- Temozolomide
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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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