scholarly journals Phase I Study of Adenoviral Delivery of the HSV-tk Gene and Ganciclovir Administration in Patients with Recurrent Malignant Brain Tumors

2000 ◽  
Vol 1 (2) ◽  
pp. 195-203 ◽  
Author(s):  
Todd W. Trask ◽  
Rebecca P. Trask ◽  
Estuardo Aguilar-Cordova ◽  
H.David Shine ◽  
Philip R. Wyde ◽  
...  
Keyword(s):  
Brain Tumors ◽  
Phase I ◽  
Phase I Study ◽  
Malignant Brain Tumors ◽  
Adenoviral Delivery

scholarly journals EPCT-17. A PHASE I AND SURGICAL STUDY OF RIBOCICLIB AND EVEROLIMUS IN CHILDREN WITH RECURRENT OR REFRACTORY MALIGNANT BRAIN TUMORS: PEDIATRIC BRAIN TUMOR CONSORTIUM INTERIM REPORT

2020 ◽  
Vol 22 (Supplement_3) ◽  
pp. iii307-iii307
Author(s):  
Mariko DeWire ◽  
Christine Fuller ◽  
Olivia Campagne ◽  
Tong Lin ◽  
Haitao Pan ◽  
...  
Keyword(s):  
Brain Tumors ◽  
Phase I ◽  
Dose Level ◽  
Phase I Study ◽  
Single Agent ◽  
Pediatric Brain Tumor ◽  
Pi3k Pathway ◽  
Neurosurgical Procedures ◽  
Common Grade ◽  
Grade 3

Abstract Genomic aberrations in the cell cycle and PI3K pathway are commonly observed in recurrent childhood brain tumors. Dual inhibition of CDK4/6 (ribociclib) and mTOR (everolimus) has strong biologic rationale, non-overlapping single-agent toxicities, and adult clinical experience. The maximum tolerated dosage (MTD) and/or recommended phase two dose (RP2D) of ribociclib and everolimus was determined in the Phase I study and ribociclib concentrations were characterized in plasma and tumor in children undergoing neurosurgical procedures. Following resection, eligible patients were enrolled in the Phase I study according to a rolling 6 design and received ribociclib and everolimus once daily for 21 days and 28 days, respectively. Patients undergoing surgery received ribociclib at the pediatric RP2D (350 mg/m2/day) for 7–10 days pre-operatively. Pharmacokinetic samples were collected on both cohorts and analyzed in nine patients on phase I study. Sixteen eligible patients enrolled on phase I study (median age 10.3 years; range: 3.9–20.4) and 5 patients were enrolled on the surgical cohort (median age 11.4 years; range: 7.2–17.1). Six patients enrolled at dose level 1 without dose limiting toxicities (DLT). Two of the three patients at dose level 2 experienced DLT (grade 3 hypertension and grade 4 ALT). The most common grade 3/4 toxicities were lymphopenia, neutropenia, and leucopenia. Everolimus concentrations following administration of everolimus alone were lower than those following drug combination, suggesting an impact of ribociclib on everolimus pharmacokinetics. The MTD/RP2D of ribociclib and everolimus in recurrent CNS tumors is 120 mg/m2 and 1.2 mg/ m2 daily for 21 days and 28 days, respectively.

Treatment of malignant brain tumors with focused ultrasound hyperthermia and radiation: results of a phase I trial

1991 ◽  
Vol 10 (3) ◽  
Author(s):  
A.N. Guthkelch ◽  
L.P. Carter ◽  
J.R. Cassady ◽  
K.H. Hynynen ◽  
R.P. Iacono ◽  
...  
Keyword(s):  
Brain Tumors ◽  
Phase I ◽  
Phase I Trial ◽  
Focused Ultrasound ◽  
Malignant Brain Tumors ◽  
Ultrasound Hyperthermia

ITCC phase I study of erlotinib as single agent in children with refractory and relapsed malignant brain tumors and in combination with irradiation in newly diagnosed brain stem glioma

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 9556-9556 ◽  
Author(s):  
B. Geoerger ◽  
D. Hargrave ◽  
A. Ndiaye ◽  
D. Frappaz ◽  
F. Doz ◽  
...  
Keyword(s):  
Brain Tumors ◽  
Phase I ◽  
Brain Stem ◽  
Phase I Study ◽  
Single Agent ◽  
Glioneuronal Tumor ◽  
Brain Stem Glioma ◽  
Newly Diagnosed ◽  
Group 2 ◽  
Group 1

9556 Background: Erlotinib hydrochloride (OSI-774), a selective inhibitor of the EGFR tyrosine kinase, may be active in childhood brain tumors, particularly in combination with irradiation. Methods: Multicenter, non-randomized phase I study with separate dose findings for erlotinib as single agent in children with refractory or relapsing brain tumors (group 1), and combined to irradiation in newly diagnosed brain stem glioma (group 2). Erlotinib was administered orally daily at 75, 100, 125 or 150 mg/m2. Dose escalation was performed in a classical 3+3 methodology for group 1 and according to the continuous reassessment method for group 2; dose-limiting toxicity (DLT) was evaluated at 3 and 6 weeks, respectively. Results: In total, 31 patients have been entered to date, 30 received treatment, 17 in group 1 (3 relapsing brain stem glioma, 4 ependymoma, 4 oligodendroglioma, 6 other) and 13 in group 2 with a median age of 9 and 6 years (range 4–16 and 2–12), respectively. Median treatment duration was 1.5 and >5 months, respectively. In group 1, 3 patients each were treated at 75 mg/m2 and 100 mg/m2, 7 at 125 mg/m2, 4 at 150 mg/m2. One patient with a glioneuronal tumor treated at 125 mg/m2 experienced G5 intra-tumoral hemorrhage at day 4 which was considered as DLT; at 150 mg/m2, 1 patient with an oligodendroglioma experienced G3 asthenia at day 18 and G3 intratumoral hemorrhage at day 29, and 1 patient with an ependymoma experienced G5 intra-tumoral hemorrhage at day 49. In group 2, 1/6 patients treated with erlotinib 75 mg/m2 and irradiation experienced seizures and died, no DLT occurred in 6 patients at 100 mg/m2. Non-hematological toxicities included G1-G2 erythema, folliculitis, dry skin, trichomegaly, G1 transaminitis, bilirubinemia, G1–3 asthenia, G1–5 intra-tumoral hemorrhage. Minor tumor response was observed in an oligodendroglioma. Pharmacokinetic and biological evaluations are ongoing. Conclusions: Erlotinib was well tolerated in children with cutaneous symptoms being the most frequent treatment toxicity. However, neurological toxicity and intra-tumoral hemorrhage was notable in these children with brain tumors. Inclusion at 125 mg/m2 is ongoing to confirm the MTD. No significant financial relationships to disclose.

scholarly journals A phase I study of ifosfamide given on alternate days to treat children with brain tumors

Cancer ◽  
1993 ◽  
Vol 71 (11) ◽  
pp. 3666-3669 ◽  
Author(s):  
Charles B. Pratt ◽  
Edwin C. Douglass ◽  
Richard Heideman ◽  
Loraine Avery ◽  
Stewart J. Kellie ◽  
...  
Keyword(s):  
Brain Tumors ◽  
Phase I ◽  
Phase I Study

scholarly journals Phase I study of fotemustine in pediatric patients with refractory brain tumors

Cancer ◽  
2002 ◽  
Vol 95 (6) ◽  
pp. 1294-1301 ◽  
Author(s):  
Darren R. Hargrave ◽  
Eric Bouffet ◽  
Janet Gammon ◽  
Nauman Tariq ◽  
Ron M. Grant ◽  
...  
Keyword(s):  
Brain Tumors ◽  
Phase I ◽  
Phase I Study ◽  
Pediatric Patients
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