Phase 1/Pilot Consortium

27 Pages·2015·0.18 MB·German

by  Crystal Reports

Phase 1/Pilot Consortium
2015

ADVL1011 – Ruxolitinib
Loh ML, Tasian SK, Rabin KR, Brown PA, Magoon D, Reid JM, Chen X, Ahern CH, Weigel BJ,
Blaney SM. A phase 1 dosing study of ruxolitinib in children with relapsed or refractory
solid tumors, leukemias, or myeloproliferative neoplasms: A Children's Oncology
Group phase 1 consortium study (ADVL1011). Pediatr Blood Cancer. 2015 May 13 [Epub
ahead of print]. PMCID: PMC Journal - In Process.

ADVL1014 – Reolysin
Kolb EA, Sampson V, Stabley D, Walter A, Sol-Church K, Cripe T, Hingorani P, Ahern CH,
Weigel BJ, Zwiebel J, Blaney SM. A phase I trial and viral clearance study of reovirus (Reolysin)
in children with relapsed or refractory extra-cranial solid tumors: a Children's Oncology Group
Phase I Consortium report. Pediatr Blood Cancer. 2015 May;62(5):751-8. PMCID:
PMC4376570.

ADVL0911 – Seneca Valley Virus (NTX-010)
Burke MJ, Ahern CH, Weigel BJ, Poirier JT, Rudin CM, Chen Y, Cripe TP, Bernhardt M, Blaney
SM. Phase 1 trial of seneca valley virus (NTX-010) in children with relapsed / refractory solid
tumors: A report of the Children's Oncology Group. Pediatr Blood Cancer. 2015 May;62(5):743-
50. PMCID: PMC4376652.

ADVL0813 – Cixutumumab (IMC-A12) + Temsirolimus (CCI-779)
Fouladi M, Perentesis JP, Wagner LM, Vinks AA, Reid JM, Ahern CH, Thomas G, Mercer C,
Krueger DA, Houghton PJ, Doyle A, Chen H, Weigel BJ, Blaney SM. A Phase I study of
cixutumumab (IMC-A12) in combination with temsirolimus (CCI-779) in children with recurrent
solid tumors: A Children's Oncology Group Phase 1 Consortium report. Clin Cancer Res. 2015
Apr 1;21(7):1558-65. PMCID: PMC4454739.

ADVL1114 – Temsirolimus (CCI-779) with Intensive Re-induction Abstract
Rheingold S, Whitlock J, Tasian S, Teachey D, Borowitz M, Liu X, Ahern CH, Minard CG, Fox
E, Weigel BJ, Blaney SM. Temsirolimus and intensive re-induction chemotherapy for 2nd or
greater relapse of acute lymphoblastic leukemia (ALL): a Children’s Oncology Group study.
2015 ASCO Annual Meeting. J Clin Oncol; 33(15s): abstr 10029.

ADVL1212 – Crizotinib with Conventional Chemotherapy Abstract
Greengard E, Mosse Y, Liu X, Ahern CH, Minard CG, Blaney SM, Fox E, Weigel BJ. A Safety
and tolerability of crizotinib in combination with chemotherapy for relapsed or refractory solid
tumors or anaplastic large cell lymphoma: a Children’s Oncology Group phase I consortium
study. 2015 ASCO Annual Meeting. J Clin Oncol; 33(15s): abstr 10058.
Phase 1/Pilot Consortium
ADVL1213 – Ontuxizumab (MORAb-004) Abstract
Norris RE, Fox E, Reid JM, Ralya AT, Liu X, Ahern CH, Minard CG, Dahl J, Eubank R, Weigel
BJ. Phase I trial of ontuxizumab (MORAb-004) in children with relapsed or refractory solid
tumors: A Children’s Oncology Group Study. 2015 ASCO Annual Meeting. J Clin Oncol;
33(15s): abstr 10036.

AHOD1221 – Brentuximab Vedotin + Gemcitabine Abstract
Cole PD, Metzger M, Drachtman RA, Horton TM, Liu X, Ahern CH, Minard CG, Fox E, Blaney
SM, Weigel BJ, Kelly K. Phase 1 trial of brentuximab vedotin in combination with gemcitabine
for pediatric and young adult patients with relapsed or refractory Hodgkin lymphoma, a
Children’s Oncology Group report. 2015 ASCO Annual Meeting. J Clin Oncol; 33(15s): abstr
8544.
Phase 1/Pilot Consortium
2014

ADVL0918 – Temsirolimus + Irinotecan and Temozolomide
Bagatell R, Norris R, Ingle AM, Ahern C, Voss S, Fox E, Little AR, Weigel BJ, Adamson PC,
Blaney S. Phase 1 trial of temsirolimus in combination with irinotecan and temozolomide in
children, adolescents and young adults with relapsed or refractory solid tumors: A children's
oncology group study. Pediatr Blood Cancer. 2014 May;61(5):833-9. PMCID: PMC4196713.

ADVL1013 – MK-2206
Fouladi M(1), Perentesis JP, Phillips CL, Leary S, Reid JM, McGovern RM, Ingle AM, Ahern
CH, Ames MM, Houghton P, Doyle LA, Weigel B, Blaney SM. A phase I trial of MK-2206 in
children with refractory malignancies: A children's oncology group study. Pediatr Blood Cancer.
2014 Jul;61(7):1246-51. PMCID: PMC4456022.

ADVL1011 – Ruxolitinib Abstract
Tasian SK, Loh ML, Rabin KR, Brown PA, Ahern CH, Weigel BJ, Blaney SM. A Phase I Study
of Ruxolitinib in Children with Relapsed/Refractory Solid Tumors, Leukemias, or
Myeloproliferative Neoplasms: A Children’s Oncology Group Phase I Consortium Study
(ADVL1011). 2014 ASCO Annual Meeting. J Clin Oncol; 32(15s): abstr 10019.

ADVL1111 – Tivantinib (ARQ 197) Abstract
Geller J, Perentesis JP, Ahern CH, Kudgus RA, Reid JM, Fox E, Blaney SM, Weigel BJ. A
Phase 1 Study of the c-Met Inhibitor, Tivantinib (ARQ 197, IND#112603) in Children with
Relapsed or Refractory Solid Tumors: A Children’s Oncology Group Study. 2014 ASCO Annual
Meeting. J Clin Oncol; 32(15s): abstr 2627.

ADVL1211 – Cabozantinib (XL184) Abstract
Chuk MK, Widemann BC, Ahern CH, Reid JM, Kim A, Wright JJ, Lodish MB, Fox E, Weigel BJ,
Blaney SM. A phase I study of Cabozantinib (XL184) in children and adolescents with recurrent
or refractory solid tumors, including CNS tumors: A Children’s Oncology Group Phase I
Consortium Trial. 2014 ASCO Annual Meeting. J Clin Oncol; 32(15s): abstr 10078.
Phase 1/Pilot Consortium
2013

ADVL1112 – Imetelstat
Thompson PA, Drissi R, Muscal J, Panditharatna EA, Fouladi M, Ingle AM, Ahern CH, Reid JM,
Lin T, Weigel BJ, Blaney SM. A Phase 1 trial of imetelstat in children with refractory or recurrent
solid tumors: A Children's Oncology Group Phase 1 Consortium study (ADVL1112). 2013 Dec
1;19(23):6578-6584. PMCID: PMC4079262.

ADVL0912 – Crizotinib
Mossé YP, Lim MS, Voss SD, Wilner K, Ruffner K, Laliberte J, Rolland D, Balis, F, Maris JM,
Weigel BJ, Ingle AM, Ahern CH, Adamson PC, Blaney SM. Safety and activity of crizotinib for
paediatric patients with refractory solid tumours or anaplastic large-cell lymphoma: a Children's
Oncology Group phase 1 consortium study. Lancet Oncol; 2013 May; 14(6):472-480. PMCID:
PMC3730818.

ADVL0819 – Vorinostat and Temozolomide in CNS Tumors
Hummel TR, Wagner LM, Ahern CH, Fouladi M, Reid JM, McGovern R, Ames MM, Gilbertson
RJ, Horton TM, Ingle AM, Weigel BJ, Blaney SM. A pediatric phase 1 Trial of vorinostat and
temozolomide in relapsed or refractory primary brain or spinal cord tumors: A Children's
Oncology Group Phase 1 Consortium study. Pediatr Blood Cancer; 2013 Sep; 60(9):1452-1457.
PMCID: PMC4139006.

ADVL0815 – Pazopanib
Glade Bender JL, Lee A, Reid JM, Baruchel S, Roberts T, Voss SD, Wu B, Ahern CH, Ingle AM,
Harris P, Weigel BJ, Blaney SM. A Phase I pharmacokinetic and pharmacodynamic study of
pazopanib in children with soft tissue sarcoma and other refractory solid tumors: A Children's
Oncology Group Phase I consortium report. J Clin Oncol; 2013 Aug; 31(24):3034-3043. PMCID:
PMC3739862.

ADVL0911 – Seneca Valley Virus (NTX-010) Abstract
Burke MJ, Ahern CH, Weigel BJ, Ingle AM, Cripe TP, Bernhardt M, Blaney SM. A phase I study
of seneca valley virus (NTX-010) in children with relapsed/refractory solid tumors (ADVL0911):
A report of the Children's Oncology Group. Presented at: The Seventh International Meeting On
Replicating Oncolytic Virus Therapeutics; 2013 June 15-18; Montreal, Canada.
Phase 1/Pilot Consortium
ADVL1014 – Reolysin Abstract
Kolb EA, Sampson V, Stabley D, Walter A, Cripe TP, Hingorani P, Ahern CH, Ingle AM, Weigel
BJ, Blaney SM. A Phase I trial and Viral Clearance Study of Reovirus (Reolysin) in Children with
Relapsed or Refractory Extra-cranial Solid Tumors: A Children’s Oncology Group Phase I
Consortium Report. Poster presented at: AACR-Pediatric Cancer at the Crossroads:
Translating Discovery Into Improved Outcomes Conference; 2013 November 3-6; San Diego,
CA.

ADVL1115 – Trebananib (AMG386) Abstract
Leary SE, Park JR, Reid JM, Ralya A, Baruchel S, Wu B, Ingle AM, Ahern CH, Weigel BJ,
Blaney SM. A phase I trial and pharmacokinetic study of trebananib (AMG386) in children with
recurrent or refractory solid tumors: A Children’s Oncology Group Phase 1 Consortium report.
2013 ASCO Annual Meeting. J Clin Oncol; 2013 May; 31(15 suppl):abstr 2538.
Phase 1/Pilot Consortium
2012

ADVL0916 - Vorinostat and Bortezomib
Muscal J, Horton TM, Ingle AM, Ahern CH, McGovern R, Reid JM, Ames MM, Espinoza-
Delgado I, Weigel BJ, Blaney SM. A phase I trial of vorinostat and bortezomib in children with
refractory or recurrent solid tumors: A Children's Oncology Group phase 1 consortium study
(ADVL0916). Pediatr Blood Cancer; 2012 Nov; 60(3):390-395. PMCID: PMCID3511610.

ADVL0812 - MLN8237
Mossé, YP, Lipsitz EG, Teachey DT, Maris JM, Weigel BJ, Adamson PC, Ingle AM, Ahern CH,
Blaney SM. Pediatric phase 1 trial and pharmacokinetic study of MLN8237, an investigational
oral selective small molecule inhibitor of aurora kinase A: A Children's Oncology Group Phase 1
Consortium study. Clin Cancer Res; 2012 Nov; 18(21):6058-6064. PMCID: PMC4008248.

ADVL0714 - VEGF Trap
Glade Bender JL, Blaney SM, Borinstein SC, Reid JM, Baruchel S, Ahern CH, Ingle AM,
Yamashiro DJ, Chen A, Weigel BJ, Adamson PC, Park JR. A phase I trial and pharmacokinetic
study of aflibercept (VEGF Trap) in children with refractory solid tumors: A Children’s Oncology
Group Phase I consortium report. Clin Cancer Res; 2012 Sep; 18(18):5081-5089. PMCID:
PMC3445751.

ADVL0712 – Cixutumumab (IMC-A12)
Malempati S, Weigel BJ, Ingle AM, Ahern CH, Carroll JM, Roberts CT, Reid JM, Schmechel S,
Voss SD, Cho SY, Chen HX, Krailo M, Adamson PC, Blaney SM. Phase I/II trial and
pharmacokinetic study of cixutumumab in pediatric patients with refractory solid tumors and
ewing sarcoma: A report from the Children's Oncology Group. J Clin Oncol; 2012 Jan;
30(3):256-262. PMCID: PMC3269952.

ADVL0612 – Sunitinib Pharmacokinetics
DuBois SG, Shusterman S, Reid JM, Ingle AM, Ahern CH, Baruchel S, Glade Bender JL, Ivy
SP, Adamson PC, Blaney SM, DuBois JJ. Tolerability and pharmacokinetic profile of a sunitinib
powder formulation in pediatric patients with refractory solid tumors: A Children's Oncology
Group study. Cancer Chemother Pharmacol; 2012 Apr; 69(4):1021-1027. PMCID:
PMC3149978.

ADVL0413 – Sorafenib
Widemann BC, Kim A, Fox E, Baruchel S, Adamson PC, Ingle AM, Glade Bender JL, Burke MJ,
Weigel BJ, Stempak D, Balis FM, Blaney SM. A Phase I trial and pharmacokinetic study of
sorafenib in children with refractory solid tumors or refractory leukemias: A Children's Oncology
Group Phase I Consortium report. Clin Cancer Res; 2012 Nov; 18(21):6011-6022. PMCID:
PMC4008314.
Phase 1/Pilot Consortium
ADVL1013 – MK 2206 Abstract
Phillips C, Fouladi M, Perentesis JP, Leary SE, McGovern R, Reid JM, Ingle AM, Ahern CH,
Ames MM, Houghton PJ, Doyle A, Weigel BJ, Blaney SM. A phase I trial of MK 2206 in children
with refractory solid tumors: A Children's Oncology Group study. 2012 ASCO Annual Meeting. J
Clin Oncol; 2012 May; 30(15 suppl):abstr 9581.

ADVL0918 – Temsirolimus + Irinotecan and Temozolomide Abstract
Bagatell R, Norris RE, Ingle AM, Ahern CH, Saggio JN, Little AR, Weigel BJ, Blaney SM. Phase
I trial of temsirolimus (TEM), irinotecan (IRN), and temozolomide (TMZ) in children with
refractory solid tumors: A Children's Oncology Group study. 2012 ASCO Annual Meeting. J Clin
Oncol; 2012 May; 30(15 suppl):abstr 9540.

ADVL0912 – Crizotinib Abstract
Mossé, YP, Balis FM, Lim MS, Blaney SM, Voss SD, Fox EJ, Bagatell R, Weigel BJ, Adamson
PC, Ingle AM, Ahern CH, Laliberte J. Efficacy of crizotinib in children with relapsed/refractory
ALK-driven tumors including anaplastic large cell lymphoma and neuroblastoma: A Children's
Oncology Group phase I consortium study. 2012 ASCO Annual Meeting. J Clin Oncol; 2012
May; 30(15 suppl):abstr 9500.

ADVL0813 – Cixutumumab (IMC-A12) + Temsirolimus Abstract
Fouladi M, Perentesis JP, Wagner LM, Ingle AM, Thomas GA, Krueger DA, Houghton P, Vinks
AA, Doyle LA, Weigel BJ, Blaney SM. A phase I trial of IMC A12 and temsirolimus in children
with refractory solid tumors: A Children’s Oncology Group study. 2012 ASCO Annual Meeting. J
Clin Oncol; 2012 May; 30(15 suppl):abstr 9541.
Phase 1/Pilot Consortium
2011

ADVL0612 - Sunitinib
DuBois SG, Shusterman S, Ingle AM, Ahern CH, Reid JM, Wu B, Baruchel S, Glade Bender JL,
Ivy SP, Grier HE, Adamson PC, Blaney SM. Phase I and pharmacokinetic study of sunitinib in
pediatric patients with refractory solid tumors: A Children’s Oncology Group study. Clin Cancer
Res; 2011 Aug; 17(15):5113-5122. PMCID: PMC3149978.

ADVL0516 – Dasatinib
Aplenc R, Blaney S, Strauss LC, Balis FM, Shusterman S, Ingle AM, Agrawal S, Sun J, Wright
J, Adamson PC. Pediatric phase I trial and pharmacokinetic study of dasatinib: A report from the
Children's Oncology Group Phase I Consortium. J Clin Oncol; 2011 Mar; 29(7):839-844.
PMCID: PMC3068059.

ADVL0516 – Dasatinib Correlative study
Guerrouahen BS, Wieder E, Blanchard EG, Lee FY, Aplenc R, Corey S. Flow Cytometric
Determination of Src Phosphorylation in Pediatric Patients Treated With Dasatinib. Pediatr
Blood Cancer; 2009 Dec; 53(6):1132-1135. PMCID: PMC2760231.

ADVL0515 –Vinblastine + Carboplatin in Low Grade Glioma
Jakacki RI, Bouffet E, Adamson PC, Ingle AM, Voss SD, Blaney SM. A Phase I Study Of
Vinblastine In Combination With Carboplatin For Children With Low-Grade Gliomas: A
Children’s Oncology Group Phase 1 Consortium Study. Neuro-oncol; 2011 Aug; 13(8):910-915.
PMCID: PMC3145477.

ADVL0419 – Valproic Acid
Su JM, Li X, Thompson PA, Ou C, Ingle AM, Russell HV, Lau CC, Adamson PC, Blaney SM.
Phase 1 study of valproic acid in pediatric patients with refractory solid or CNS tumors: A
Children's Oncology Group report. Clin Cancer Res; 2011 Feb; 17(3):589-597. PMCID:
PMC3064523.

ADVL0319 – Lenalidomide
Berg S, Cairo M, Russell HV, Ayello J, Ingle AM, Lau H, Chen N, Adamson P, Blaney S. Safety,
pharmacokinetics and immunomodulatory effects of lenalidomide in children and adolescents
with relapsed/refractory solid tumors or myelodysplastic syndrome: A Children's Oncology
Group Phase I Consortium report. J Clin Oncol; 2011 Jan; 29(3):316-323. PMCID:
PMC3056465.

ADVL0116 – Tipifarnib
Widemann B, Arceci R, Jayaprakash N, Fox E, Zannikos P, Goodspeed W, Goodwin A, Wright
J, Blaney S, Adamson P, Balis F. Phase 1 trial and pharmacokinetic study of the farnesyl
transferase inhibitor tipifarnib in children and adolescents with refractory leukemias: A report
from the Children’s Oncology Group. Pediatr Blood Cancer; 2011 Feb; 56(2):226-233.
PMCID: PMC3271115.
Phase 1/Pilot Consortium
ADVL0916 – Vorinostat and Bortezomib Abstract
Muscal J, Thompson PA, Horton TM, Ingle AM, Ahern CH, McGovern R, Reid JM, Ames MM,
Weigel BJ, Blaney SM. A phase I trial of vorinostat and bortezomib in children with refractory or
recurrent solid tumors: A Children's Oncology Group study. 2011 ASCO Annual Meeting. J Clin
Oncol; 2011 May; 29(15 suppl):abstr 9522.

ADVL0819 – Vorinostat and Temozolomide Abstract
Hummel TR, Wagner LM, Ahern CH, McGovern R, Ames MM, Gilbertson RJ, Horton TM, Ingle
AM, Weigel BJ, Blaney SM. A pediatric phase I trial of vorinostat and temozolomide in relapsed
or refractory primary brain or spinal cord tumors: A Children’s Oncology Group Phase I
Consortium Study. 2011 ASCO Annual Meeting. J Clin Oncol; 2011 May; 29(15 suppl):abstr
9579.

ADVL0815 – Pazopanib Abstract
Glade Bender JL, Lee A, Adamson PC, Ingle AM, Ahern CH, Wu B, Baruchel S, Harris PJ,
Ames MM, Weigel BJ, Blaney SM. Phase I study of pazopanib in children with relapsed or
refractory solid tumors (ADVL0815): A Children's Oncology Group Phase I Consortium Trial.
2011 ASCO Annual Meeting. J Clin Oncol; 2011 Jun; 29(15 suppl):abstr 9501.

ADVL0815 – Pazopanib Abstract
Glade Bender JL, Khrichenko D, Voss SD, Lee A, Ingle AM, Ahern CH, Weigel BJ, Blaney SM,
Roberts T. An expanded imaging cohort of pazopanib in children and adolescents with relapsed
or refractory soft tissue sarcoma (ADVL0815): A Children's Oncology Group phase I consortium
trial. In: Proceedings of the AACR-NCI-EORTC International Conference: Molecular Targets
and Cancer Therapeutics; 2011 Nov 12-16; San Francisco, CA. Mol Cancer Ther; 2011 Nov;
10(11 suppl):abstr nr C108.

ADVL0813 – Cixutumumab (IMC-A12) + Temsirolimus Abstract
Fouladi M, Perentesis JP, Wagner LM, Ingle AM, Gammon J, Thomas G, Krueger DA,
Houghton P, Vinks S, Weigel BJ, Blaney S. A phase I trial of IMC-A12 and temsirolimus in
children with refractory solid tumors: A Children's Oncology Group Study. 2011 ASCO Annual
Meeting. J Clin Oncol; 2011 May; 29(15 suppl):abstr 9520.

ADVL0612 – Sunitinib Abstract
DuBois SG, Shusterman S, Reid JM, Ingle AM, Ahern CH, Baruchel S, Glade-Bender J, Ivy P,
Grier H, Adamson PC, Blaney SM. Tolerability and Pharmacokinetic Profile of Sunitinib Given
as a Powder Formulation to Children with Refractory Solid Tumors: A Children’s Oncology
Group Study. In: 43rd Congress of the International Society of Paediatric Oncology (SIOP)
2011 Auckland, New Zealand, 28th–30th October, 2011, SIOP Abstracts. Pediatr Blood Cancer;
2011 Nov; 57(5): 717-718, Oral Presentation #O042.
Phase 1/Pilot Consortium
Phase 1 Correlatives Studies - Antiangiogenesis Biomarkers Abstract
Baruchel S, Wu B, Mokhtari RB, Glade Bender JL, DuBois SG, Widemann BC, Park JR,
Stempak D, Ahern CH, Weigel BJ. Surrogate biomarkers of antiangiogenesis in Children's
Oncology Group (COG) phase I trials. 2011 ASCO Annual Meeting. J Clin Oncol; 2011 May;
29(15 suppl):abstr 9502.