The Experts below are selected from a list of 15 Experts worldwide ranked by ideXlab platform
Ian D Davis - One of the best experts on this subject based on the ideXlab platform.
-
a randomized double blinded placebo controlled phase ii trial of recombinant human leukemia inhibitory factor rhulif Emfilermin am424 to prevent chemotherapy induced peripheral neuropathy
Clinical Cancer Research, 2005Co-Authors: Ian D Davis, L Kiers, Lachlan Macgregor, Michael A Quinn, Joseph C Arezzo, Michael D Green, Mark Rosenthal, Michael Chia, Michael Michael, Peter BartleyAbstract:Purpose : To determine whether recombinant human leukemia inhibitory factor (rhuLIF, AM424, Emfilermin) can prevent or ameliorate the development of chemotherapy-induced peripheral neuropathy (CIPN) after treatment with carboplatin (AUC 6) and paclitaxel (175 mg/m 2 over 3 hours). Experimental Design : Randomized double-blind placebo-controlled phase II clinical trial. Eligible patients had solid tumors for which treatment with carboplatin/paclitaxel was appropriate. The primary end point was a standardized composite peripheral nerve electrophysiology (CPNE) score, based on nerve velocities and amplitudes, measured at baseline and after four cycles of chemotherapy. Secondary efficacy end points included CPNE score at last cycle and at exit evaluation, vibration perception threshold, H-reflex latency, symptom scores, and quantitative assessment of neurologic signs. Study drug was given s.c. daily for 7 days starting the day before chemotherapy. Patients were randomized to receive low-dose rhuLIF (2 μg/kg), high-dose rhuLIF (4 μg/kg), or placebo. Results : Patients ( n = 117) were randomized across seven neurology test centers. Thirty-six patients received low dose rhuLIF (2 μg/kg), 39 received high dose rhuLIF (4 μg/kg) and 42 received placebo. rhuLIF was well tolerated with 95% compliance and no adverse effects on quality of life. No differences between groups in CPNE or any of the individual neurologic testing variables were observed between baseline and cycle 4 or by the secondary efficacy variables. Conclusions : rhuLIF is not effective in preventing CIPN caused by carboplatin and paclitaxel. CPNE is a reliable and valid tool that was sensitive to the onset and progression of CIPN.
-
A Phase I Study of Recombinant Human Leukemia Inhibitory Factor in Patients with Advanced Cancer
Clinical Cancer Research, 2003Co-Authors: Dishan H. Gunawardana, Ian D Davis, Michael D Green, Russell L. Basser, Jonathan Cebon, Paul Mitchell, Craig Underhill, Trevor J. Kilpatrick, Katrina Reardon, Peter BardyAbstract:Purpose: Leukemia inhibitory factor (LIF) is a pleiotropic molecule of the interleukin 6 family of cytokines. We aimed to examine the safety, pharmacokinetics, and biological effects of recombinant human LIF (rhLIF, Emfilermin) in patients with advanced cancer. Experimental Design: In stage 1 of the study, 34 patients received rhLIF or placebo (3:1 ratio) at doses of 0.25–16.0 μg/kg/day or 4.0 μg/kg three times daily for 7 days. In stage 2, 40 patients received rhLIF or placebo, either once daily for 14 days commencing the day after chemotherapy (0.25–8.0 μg/kg/day) or for 7 days commencing the day before chemotherapy (4.0 μg/kg three times daily). The chemotherapy was cisplatin 75 mg/m 2 and paclitaxel 135 mg/m 2 . Results: In stage 1, platelet counts increased in most patients, including those who received placebo. Blood progenitor cells increased in response to rhLIF. In stage 2, platelet recovery to baseline levels was earlier for patients receiving higher doses of rhLIF (≥4.0 μg/kg/day; P = 0.02). The neutrophil nadir after chemotherapy was less severe in patients receiving ≥4.0 μg/kg/day of rhLIF. In stages 1 and 2, increases in C reactive protein were seen at higher doses. Several patients developed evidence of autonomic dysfunction, in particular impotence and episodic hypotension. The dose-limiting toxicities were hypotension and rigors. Pharmacokinetic studies demonstrated a short half-life (1–5 h) independent of dose. Conclusions: We demonstrated a biological effect of rhLIF on blood progenitor cells, C reactive protein levels, and hemopoietic recovery after chemotherapy.
Peter Bartley - One of the best experts on this subject based on the ideXlab platform.
-
a randomized double blinded placebo controlled phase ii trial of recombinant human leukemia inhibitory factor rhulif Emfilermin am424 to prevent chemotherapy induced peripheral neuropathy
Clinical Cancer Research, 2005Co-Authors: Ian D Davis, L Kiers, Lachlan Macgregor, Michael A Quinn, Joseph C Arezzo, Michael D Green, Mark Rosenthal, Michael Chia, Michael Michael, Peter BartleyAbstract:Purpose : To determine whether recombinant human leukemia inhibitory factor (rhuLIF, AM424, Emfilermin) can prevent or ameliorate the development of chemotherapy-induced peripheral neuropathy (CIPN) after treatment with carboplatin (AUC 6) and paclitaxel (175 mg/m 2 over 3 hours). Experimental Design : Randomized double-blind placebo-controlled phase II clinical trial. Eligible patients had solid tumors for which treatment with carboplatin/paclitaxel was appropriate. The primary end point was a standardized composite peripheral nerve electrophysiology (CPNE) score, based on nerve velocities and amplitudes, measured at baseline and after four cycles of chemotherapy. Secondary efficacy end points included CPNE score at last cycle and at exit evaluation, vibration perception threshold, H-reflex latency, symptom scores, and quantitative assessment of neurologic signs. Study drug was given s.c. daily for 7 days starting the day before chemotherapy. Patients were randomized to receive low-dose rhuLIF (2 μg/kg), high-dose rhuLIF (4 μg/kg), or placebo. Results : Patients ( n = 117) were randomized across seven neurology test centers. Thirty-six patients received low dose rhuLIF (2 μg/kg), 39 received high dose rhuLIF (4 μg/kg) and 42 received placebo. rhuLIF was well tolerated with 95% compliance and no adverse effects on quality of life. No differences between groups in CPNE or any of the individual neurologic testing variables were observed between baseline and cycle 4 or by the secondary efficacy variables. Conclusions : rhuLIF is not effective in preventing CIPN caused by carboplatin and paclitaxel. CPNE is a reliable and valid tool that was sensitive to the onset and progression of CIPN.
Michael D Green - One of the best experts on this subject based on the ideXlab platform.
-
a randomized double blinded placebo controlled phase ii trial of recombinant human leukemia inhibitory factor rhulif Emfilermin am424 to prevent chemotherapy induced peripheral neuropathy
Clinical Cancer Research, 2005Co-Authors: Ian D Davis, L Kiers, Lachlan Macgregor, Michael A Quinn, Joseph C Arezzo, Michael D Green, Mark Rosenthal, Michael Chia, Michael Michael, Peter BartleyAbstract:Purpose : To determine whether recombinant human leukemia inhibitory factor (rhuLIF, AM424, Emfilermin) can prevent or ameliorate the development of chemotherapy-induced peripheral neuropathy (CIPN) after treatment with carboplatin (AUC 6) and paclitaxel (175 mg/m 2 over 3 hours). Experimental Design : Randomized double-blind placebo-controlled phase II clinical trial. Eligible patients had solid tumors for which treatment with carboplatin/paclitaxel was appropriate. The primary end point was a standardized composite peripheral nerve electrophysiology (CPNE) score, based on nerve velocities and amplitudes, measured at baseline and after four cycles of chemotherapy. Secondary efficacy end points included CPNE score at last cycle and at exit evaluation, vibration perception threshold, H-reflex latency, symptom scores, and quantitative assessment of neurologic signs. Study drug was given s.c. daily for 7 days starting the day before chemotherapy. Patients were randomized to receive low-dose rhuLIF (2 μg/kg), high-dose rhuLIF (4 μg/kg), or placebo. Results : Patients ( n = 117) were randomized across seven neurology test centers. Thirty-six patients received low dose rhuLIF (2 μg/kg), 39 received high dose rhuLIF (4 μg/kg) and 42 received placebo. rhuLIF was well tolerated with 95% compliance and no adverse effects on quality of life. No differences between groups in CPNE or any of the individual neurologic testing variables were observed between baseline and cycle 4 or by the secondary efficacy variables. Conclusions : rhuLIF is not effective in preventing CIPN caused by carboplatin and paclitaxel. CPNE is a reliable and valid tool that was sensitive to the onset and progression of CIPN.
-
A Phase I Study of Recombinant Human Leukemia Inhibitory Factor in Patients with Advanced Cancer
Clinical Cancer Research, 2003Co-Authors: Dishan H. Gunawardana, Ian D Davis, Michael D Green, Russell L. Basser, Jonathan Cebon, Paul Mitchell, Craig Underhill, Trevor J. Kilpatrick, Katrina Reardon, Peter BardyAbstract:Purpose: Leukemia inhibitory factor (LIF) is a pleiotropic molecule of the interleukin 6 family of cytokines. We aimed to examine the safety, pharmacokinetics, and biological effects of recombinant human LIF (rhLIF, Emfilermin) in patients with advanced cancer. Experimental Design: In stage 1 of the study, 34 patients received rhLIF or placebo (3:1 ratio) at doses of 0.25–16.0 μg/kg/day or 4.0 μg/kg three times daily for 7 days. In stage 2, 40 patients received rhLIF or placebo, either once daily for 14 days commencing the day after chemotherapy (0.25–8.0 μg/kg/day) or for 7 days commencing the day before chemotherapy (4.0 μg/kg three times daily). The chemotherapy was cisplatin 75 mg/m 2 and paclitaxel 135 mg/m 2 . Results: In stage 1, platelet counts increased in most patients, including those who received placebo. Blood progenitor cells increased in response to rhLIF. In stage 2, platelet recovery to baseline levels was earlier for patients receiving higher doses of rhLIF (≥4.0 μg/kg/day; P = 0.02). The neutrophil nadir after chemotherapy was less severe in patients receiving ≥4.0 μg/kg/day of rhLIF. In stages 1 and 2, increases in C reactive protein were seen at higher doses. Several patients developed evidence of autonomic dysfunction, in particular impotence and episodic hypotension. The dose-limiting toxicities were hypotension and rigors. Pharmacokinetic studies demonstrated a short half-life (1–5 h) independent of dose. Conclusions: We demonstrated a biological effect of rhLIF on blood progenitor cells, C reactive protein levels, and hemopoietic recovery after chemotherapy.
Michael Chia - One of the best experts on this subject based on the ideXlab platform.
-
a randomized double blinded placebo controlled phase ii trial of recombinant human leukemia inhibitory factor rhulif Emfilermin am424 to prevent chemotherapy induced peripheral neuropathy
Clinical Cancer Research, 2005Co-Authors: Ian D Davis, L Kiers, Lachlan Macgregor, Michael A Quinn, Joseph C Arezzo, Michael D Green, Mark Rosenthal, Michael Chia, Michael Michael, Peter BartleyAbstract:Purpose : To determine whether recombinant human leukemia inhibitory factor (rhuLIF, AM424, Emfilermin) can prevent or ameliorate the development of chemotherapy-induced peripheral neuropathy (CIPN) after treatment with carboplatin (AUC 6) and paclitaxel (175 mg/m 2 over 3 hours). Experimental Design : Randomized double-blind placebo-controlled phase II clinical trial. Eligible patients had solid tumors for which treatment with carboplatin/paclitaxel was appropriate. The primary end point was a standardized composite peripheral nerve electrophysiology (CPNE) score, based on nerve velocities and amplitudes, measured at baseline and after four cycles of chemotherapy. Secondary efficacy end points included CPNE score at last cycle and at exit evaluation, vibration perception threshold, H-reflex latency, symptom scores, and quantitative assessment of neurologic signs. Study drug was given s.c. daily for 7 days starting the day before chemotherapy. Patients were randomized to receive low-dose rhuLIF (2 μg/kg), high-dose rhuLIF (4 μg/kg), or placebo. Results : Patients ( n = 117) were randomized across seven neurology test centers. Thirty-six patients received low dose rhuLIF (2 μg/kg), 39 received high dose rhuLIF (4 μg/kg) and 42 received placebo. rhuLIF was well tolerated with 95% compliance and no adverse effects on quality of life. No differences between groups in CPNE or any of the individual neurologic testing variables were observed between baseline and cycle 4 or by the secondary efficacy variables. Conclusions : rhuLIF is not effective in preventing CIPN caused by carboplatin and paclitaxel. CPNE is a reliable and valid tool that was sensitive to the onset and progression of CIPN.
Michael Michael - One of the best experts on this subject based on the ideXlab platform.
-
a randomized double blinded placebo controlled phase ii trial of recombinant human leukemia inhibitory factor rhulif Emfilermin am424 to prevent chemotherapy induced peripheral neuropathy
Clinical Cancer Research, 2005Co-Authors: Ian D Davis, L Kiers, Lachlan Macgregor, Michael A Quinn, Joseph C Arezzo, Michael D Green, Mark Rosenthal, Michael Chia, Michael Michael, Peter BartleyAbstract:Purpose : To determine whether recombinant human leukemia inhibitory factor (rhuLIF, AM424, Emfilermin) can prevent or ameliorate the development of chemotherapy-induced peripheral neuropathy (CIPN) after treatment with carboplatin (AUC 6) and paclitaxel (175 mg/m 2 over 3 hours). Experimental Design : Randomized double-blind placebo-controlled phase II clinical trial. Eligible patients had solid tumors for which treatment with carboplatin/paclitaxel was appropriate. The primary end point was a standardized composite peripheral nerve electrophysiology (CPNE) score, based on nerve velocities and amplitudes, measured at baseline and after four cycles of chemotherapy. Secondary efficacy end points included CPNE score at last cycle and at exit evaluation, vibration perception threshold, H-reflex latency, symptom scores, and quantitative assessment of neurologic signs. Study drug was given s.c. daily for 7 days starting the day before chemotherapy. Patients were randomized to receive low-dose rhuLIF (2 μg/kg), high-dose rhuLIF (4 μg/kg), or placebo. Results : Patients ( n = 117) were randomized across seven neurology test centers. Thirty-six patients received low dose rhuLIF (2 μg/kg), 39 received high dose rhuLIF (4 μg/kg) and 42 received placebo. rhuLIF was well tolerated with 95% compliance and no adverse effects on quality of life. No differences between groups in CPNE or any of the individual neurologic testing variables were observed between baseline and cycle 4 or by the secondary efficacy variables. Conclusions : rhuLIF is not effective in preventing CIPN caused by carboplatin and paclitaxel. CPNE is a reliable and valid tool that was sensitive to the onset and progression of CIPN.