NCT01592045 is a Phase 1/Phase 2 clinical trial of ch14.18 -NCI in Neuroblastoma, sponsored by United Therapeutics.

Who is sponsoring NCT01592045?

NCT01592045 is sponsored by United Therapeutics.

What drugs are being tested in NCT01592045?

Interventions in NCT01592045: ch14.18 -NCI, ch14.18-UTC, Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF), Aldesleukin (IL-2), Isotretinoin.

What condition does NCT01592045 study?

NCT01592045 studies Neuroblastoma.

Is NCT01592045 still recruiting?

NCT01592045 is currently completed. Last updated 20 August 2015.

Are results published for NCT01592045?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2015-08-20 · How we verify

NCT01592045

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Comparative Pharmacokinetic and Safety Study of Chimeric Monoclonal Antibody ch14.18 With Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF), Interleukin-2 (IL-2) and Isotretinoin in High Risk Neuroblastoma Patients Following Myeloablative Therapy

Completed Phase 1/Phase 2 Results posted Last updated 20 August 2015

What this trial tests

Phase 1/Phase 2 trial testing ch14.18 -NCI in Neuroblastoma in 28 participants. Completed in 1 June 2014.

Timeline

1 August 2012

Primary endpoint
1 June 2014

1 June 2014

Quick facts

Lead sponsor	United Therapeutics
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	28
Start date	1 August 2012
Primary completion	1 June 2014
Estimated completion	1 June 2014
Sites	13 locations across United States

Drugs / interventions tested

ch14.18 -NCI — full drug profile →
ch14.18-UTC — full drug profile →
Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)
Aldesleukin (IL-2) — full drug profile →
Isotretinoin (ISOTRETINOIN) — full drug profile →

Conditions studied

Neuroblastoma — all drugs for Neuroblastoma →

Sponsor

United Therapeutics — full company profile →

Who can join

Under 8, any sex, with Neuroblastoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Area Under the Plasma Concentration Curve (AUC)
Time frame: PK samples obtained during Courses 1 and 3: Days 0, 3, 4, 5, 6, 7, 9, 10, 11, 14, 15, 16, 17; PK samples obtained during Courses 2 and 4: Days 0, 7, 10; End of Treatment
Twenty-two PK samples will be obtained at the following timepoints: Courses 1 and 3: Day: 0 Days: 3, 4, 5 and 6: post ch14.18 Days 7:10 to 14 hours post ch14.18 Days 9 to 11: Single sample Days 14 to 17: Single sample Courses 2 and 4: Day 0: Pre-IL-2 Day 7: Pre-ch14.18 Day 10 (Course 4 only): Post ch14.18 End of Treatment: Within 2 weeks post isotretinoin
Peak Plasma Concentration (Cmax)
Time frame: PK samples obtained during Courses 1 and 3: Days 0, 3, 4, 5, 6, 7, 9, 10, 11, 14, 15, 16, 17; PK samples obtained during Courses 2 and 4: Days 0, 7, 10; End of Treatment
Twenty-two PK samples will be obtained at the following timepoints: Courses 1 and 3: Day: 0 Days: 3, 4, 5 and 6: post ch14.18 Days 7:10 to 14 hours post ch14.18 Days 9 to 11: Single sample Days 14 to 17: Single sample Courses 2 and 4: Day 0: Pre-IL-2 Day 7: Pre-ch14.18 Day 10 (Course 4 only): Post ch14.18 End of Treatment: Within 2 weeks post isotretinoin

Sponsor's own description

The purpose of this study is to compare the pharmacokinetics (blood levels) and safety of chimeric (ch) 14.18 manufactured by two independent drug makers (United Therapeutics \[UTC\] or the National Cancer Institute \[NCI\]).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Trial watch: Monoclonal antibodies in cancer therapy.
Vacchelli E, Eggermont A, Galon J, Sautès-Fridman C, et al · · 2013 · cited 80× · PMID 23482847 · DOI 10.4161/onci.22789
Clinical Application of Cytokines in Cancer Immunotherapy.
Qiu Y, Su M, Liu L, Tang Y, et al · · 2021 · cited 76× · PMID 34079226 · DOI 10.2147/dddt.s308578
New Strategies Using Antibody Combinations to Increase Cancer Treatment Effectiveness.
Corraliza-Gorjón I, Somovilla-Crespo B, Santamaria S, Garcia-Sanz JA, et al · · 2017 · cited 49× · PMID 29312320 · DOI 10.3389/fimmu.2017.01804
Trial watch: Immunostimulatory cytokines in cancer therapy.
Vacchelli E, Aranda F, Obrist F, Eggermont A, et al · · 2014 · cited 47× · PMID 25083328 · DOI 10.4161/onci.29030
Trial Watch: Immunostimulatory cytokines.
Vacchelli E, Eggermont A, Fridman WH, Galon J, et al · · 2013 · cited 47× · PMID 24073369 · DOI 10.4161/onci.24850
Trial Watch-Immunostimulation with cytokines in cancer therapy.
Vacchelli E, Aranda F, Bloy N, Buqué A, et al · · 2016 · cited 43× · PMID 27057468 · DOI 10.1080/2162402x.2015.1115942
Trial watch: Tumor-targeting monoclonal antibodies for oncological indications.
Vacchelli E, Pol J, Bloy N, Eggermont A, et al · · 2015 · cited 32× · PMID 25949870 · DOI 10.4161/2162402x.2014.985940
Glycosylation Targeting: A Paradigm Shift in Cancer Immunotherapy.
Ren X, Lin S, Guan F, Kang H. · · 2024 · cited 30× · PMID 38725856 · DOI 10.7150/ijbs.93806

Verify or expand the search:

Other recruiting trials for Neuroblastoma

Currently open trials in the same condition.

NCT07399821 — An Imaging Study of Anti-GD2-800CW in Patients With Neuroblastoma · Phase 1, PHASE2 · recruiting
NCT06995872 — Phase I Trial of rhIL-15 Plus Dinutuximab Plus Irinotecan/Temozolomide for Children and Young Adults With Relapsed/Refra · Phase 1 · recruiting
NCT06942039 — Pilot Study of IT Topotecan and Maintenance Chemotherapy for HR-EBTs in Children < 6 Years, Post Consolidation · EARLY_PHASE1 · recruiting
NCT07067346 — Safety & Efficacy of IR-101 in Relapsed/Refractory Neuroblastoma · EARLY_PHASE1 · recruiting
NCT07027748 — Feasibility Study of Prolonged Administration of Naxitamab, Irinotecan, and Temozolomide for Patients With Relapsed or R · Phase 1 · recruiting

Other United Therapeutics trials

Trials by the same sponsor.

NCT06388421 — DeciPHer-ILD: A Real-world Patient Registry in Group 3 Pulmonary Hypertension Associated With Interstitial Lung Disease · recruiting
NCT05060315 — Evaluate Real-World Use of Next Generation Infusion Pumps to Administer Remodulin · terminated
NCT05203510 — A Study of a Mean Pulmonary Artery Pressure-Targeted Approach With Early and Rapid Treprostinil Therapy to Reverse Right · Phase 4 · active not recruiting
NCT05255991 — Multinational Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis · Phase 3 · completed
NCT04708782 — Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01592045 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by United Therapeutics
Last refreshed: 20 August 2015

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01592045.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing