Phase I study of combined alpha Interferon, alpha difluoromethylornithine (DFMO), and doxorubicin in advanced malignancy

Vinod Ganju; John H. Edmonson; Jan C. Buckner

doi:10.1007/BF00873231

Phase I study of combined alpha Interferon, alpha difluoromethylornithine (DFMO), and doxorubicin in advanced malignancy

Vinod Ganju, John H. Edmonson, Jan C. Buckner

Medical Oncology

Research output: Contribution to journal › Article › peer-review

7 Scopus citations

Abstract

Interferon (IFN) and conventional cytotoxic chemotherapeutic agents have been successfully combined in various studies. Alpha difluoromethylornithine (DFMO) is a novel antitumor agent which is an inhibitor of polyamine metabolism. A phase I study of IFN 24 × 10⁶ U/m²/day IM (days 3-7), DFMO 9 gm/m² p.o. daily (days 1-7), and a variable dose of doxorubicin starting at 20 mg/m² (day 6), of each 28 day cycle was performed. The aim of the study was to determine the maximally tolerable dose of doxorubicin in this combination. Three patients were treated with doxorubicin at 20 mg/m² and six patients at 40 mg/m². The dose limiting toxicities were neutropenia, fatigue and fever. All other toxicities were mild and there was no grade IV toxicity. A doxorubicin dose of 40 mg/m² produced tolerable toxicity and is recommended for phase II studies. No major antitumor effects were seen.

Original language	English (US)
Pages (from-to)	25-27
Number of pages	3
Journal	Investigational New Drugs
Volume	12
Issue number	1
DOIs	https://doi.org/10.1007/BF00873231
State	Published - Mar 1994

Keywords

Interferon alpha
advanced malignancies
difluoromethylornithine
doxorubicin
polyamine metabolism

ASJC Scopus subject areas

Oncology
Pharmacology
Pharmacology (medical)

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10.1007/BF00873231

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title = "Phase I study of combined alpha Interferon, alpha difluoromethylornithine (DFMO), and doxorubicin in advanced malignancy",

abstract = "Interferon (IFN) and conventional cytotoxic chemotherapeutic agents have been successfully combined in various studies. Alpha difluoromethylornithine (DFMO) is a novel antitumor agent which is an inhibitor of polyamine metabolism. A phase I study of IFN 24 × 106 U/m2/day IM (days 3-7), DFMO 9 gm/m2 p.o. daily (days 1-7), and a variable dose of doxorubicin starting at 20 mg/m2 (day 6), of each 28 day cycle was performed. The aim of the study was to determine the maximally tolerable dose of doxorubicin in this combination. Three patients were treated with doxorubicin at 20 mg/m2 and six patients at 40 mg/m2. The dose limiting toxicities were neutropenia, fatigue and fever. All other toxicities were mild and there was no grade IV toxicity. A doxorubicin dose of 40 mg/m2 produced tolerable toxicity and is recommended for phase II studies. No major antitumor effects were seen.",

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author = "Vinod Ganju and Edmonson, {John H.} and Buckner, {Jan C.}",

year = "1994",

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doi = "10.1007/BF00873231",

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journal = "Investigational New Drugs",

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T1 - Phase I study of combined alpha Interferon, alpha difluoromethylornithine (DFMO), and doxorubicin in advanced malignancy

AU - Ganju, Vinod

AU - Edmonson, John H.

AU - Buckner, Jan C.

PY - 1994/3

Y1 - 1994/3

N2 - Interferon (IFN) and conventional cytotoxic chemotherapeutic agents have been successfully combined in various studies. Alpha difluoromethylornithine (DFMO) is a novel antitumor agent which is an inhibitor of polyamine metabolism. A phase I study of IFN 24 × 106 U/m2/day IM (days 3-7), DFMO 9 gm/m2 p.o. daily (days 1-7), and a variable dose of doxorubicin starting at 20 mg/m2 (day 6), of each 28 day cycle was performed. The aim of the study was to determine the maximally tolerable dose of doxorubicin in this combination. Three patients were treated with doxorubicin at 20 mg/m2 and six patients at 40 mg/m2. The dose limiting toxicities were neutropenia, fatigue and fever. All other toxicities were mild and there was no grade IV toxicity. A doxorubicin dose of 40 mg/m2 produced tolerable toxicity and is recommended for phase II studies. No major antitumor effects were seen.

AB - Interferon (IFN) and conventional cytotoxic chemotherapeutic agents have been successfully combined in various studies. Alpha difluoromethylornithine (DFMO) is a novel antitumor agent which is an inhibitor of polyamine metabolism. A phase I study of IFN 24 × 106 U/m2/day IM (days 3-7), DFMO 9 gm/m2 p.o. daily (days 1-7), and a variable dose of doxorubicin starting at 20 mg/m2 (day 6), of each 28 day cycle was performed. The aim of the study was to determine the maximally tolerable dose of doxorubicin in this combination. Three patients were treated with doxorubicin at 20 mg/m2 and six patients at 40 mg/m2. The dose limiting toxicities were neutropenia, fatigue and fever. All other toxicities were mild and there was no grade IV toxicity. A doxorubicin dose of 40 mg/m2 produced tolerable toxicity and is recommended for phase II studies. No major antitumor effects were seen.

KW - Interferon alpha

KW - advanced malignancies

KW - difluoromethylornithine

KW - doxorubicin

KW - polyamine metabolism

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JO - Investigational New Drugs

JF - Investigational New Drugs

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Phase I study of combined alpha Interferon, alpha difluoromethylornithine (DFMO), and doxorubicin in advanced malignancy

Abstract

Keywords

ASJC Scopus subject areas

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