Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01601535 · ClinicalTrials.gov registry record · Phase 1
Study of MLN8237 in Combination With Irinotecan and Temozolomide
A Phase 1 study of Neuroblastoma, sponsored by New Approaches to Neuroblastoma Therapy Consortium.
- Completed
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
- 13
- Study locations
NCT01601535: Completed Phase 1 study of Neuroblastoma, sponsored by New Approaches to Neuroblastoma Therapy Consortium.
NCT01601535 is a Phase 1 study of Neuroblastoma that has completed, run by New Approaches to Neuroblastoma Therapy Consortium. The registered enrollment target is 54 participants, below the 238-participant average among 94 other Neuroblastoma trials with a reported enrollment target (77% lower). The trial reports 13 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01601535, a Phase 1 study of Neuroblastoma, has completed, sponsored by New Approaches to Neuroblastoma Therapy Consortium.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
- 13
- Study locations
Study Summary
The goal of the first part of this clinical trial (Phase I portion) is to study the side effects, drug breakdown (pharmacokinetics), and dosing of the drug MLN8237 when added to standard chemotherapy drugs, irinotecan and temozolomide. The goal of the second part of this clinical trial (Phase II portion) is to learn how many children and young adults show improvements in their neuroblastoma when treated with the combination of MLN8237, irinotecan, and temozolomide.
Primary Outcome
The MTD was the highest dose level tested at which fewer than two of six patients had first course DLT. Hematologic DLT was defined as grade 4 neutropenia for more than 7 days, need for platelet transfusion for a platelet count of less than 20,000/mL twice within a 7-day period, or greater than 14-day delay in the start of a subsequent course because of neutropenia or thrombocytopenia. Nonhematologic DLT was defined as any nonhematologic toxicity that delayed the start of a subsequent cycle by m
Conditions Studied
Interventions
- DRUG Temozolomide
- DRUG Irinotecan
- DRUG MLN8237
Study Locations (13)
California
- Children's Hospital Los Angeles - Los Angeles
- Lucile Packard Children's Hospital at Stanford University Medical Center - Palo Alto
- UCSF Helen Diller Family Comprehensive Cancer Center - San Francisco
Colorado
- Children Hospital of Colorado - Aurora
Georgia
- Children's Healthcare of Atlanta - Atlanta
Illinois
- University of Chicago Comer Children's Hospital - Chicago
Massachusetts
- Childrens Hospital Boston, Dana-Farber Cancer Institute. - Boston
Michigan
- University of Michigan Comprehensive Cancer Center - Ann Arbor
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2012-05 |
| Est. Completion | 2018-07-25 |
| Phase | Phase 1 |
What the finished NCT01601535 record still lists
NCT01601535 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 238-participant average among 94 other Neuroblastoma trials with a reported enrollment target (77% lower).
The record links to 1 condition, with Neuroblastoma appearing as the primary indexed condition, and to 3 interventions - of which Temozolomide is the first listed.
NCT01601535 lists 13 locations in 11 states (California, Colorado, Georgia).
Frequently Asked Questions
What is clinical trial NCT01601535 about?
NCT01601535 is a clinical study titled "Study of MLN8237 in Combination With Irinotecan and Temozolomide". The goal of the first part of this clinical trial (Phase I portion) is to study the side effects, drug breakdown (pharmacokinetics), and dosing of the drug MLN8237 when added to standard chemotherapy drugs, irinotecan and temozolomide. The goal of the second part of this clinical trial (Phase II po...
What is the current status of trial NCT01601535?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2012-05. Estimated completion is 2018-07-25.
What conditions does trial NCT01601535 study?
This clinical trial studies the following conditions: Neuroblastoma.
What interventions are being tested in trial NCT01601535?
The interventions under investigation include: Temozolomide (DRUG), Irinotecan (DRUG), MLN8237 (DRUG).
Who is sponsoring clinical trial NCT01601535?
This trial is sponsored by New Approaches to Neuroblastoma Therapy Consortium, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01601535 being conducted?
This trial has 13 study locations across California, Colorado, Georgia, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Neuroblastoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01601535's enrollment target sits among peer trials
54 45th of 94 higher than 50 of 94 other Neuroblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neuroblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Silmitasertib (CX-4945) in Combination With Chemotherapy for Relapsed Refractory Solid Tumors
RECRUITING · Phase 1
-
B7-H3-Specific Chimeric Antigen Receptor Autologous T-Cell Therapy for Pediatric Patients With Solid Tumors (3CAR)
RECRUITING · Phase 1
-
Autologous B7-H3 Chimeric Antigen Receptor T Cells in Relapsed/Refractory Solid Tumors
RECRUITING · Phase 1
-
Selective Antigen Specific T Cells and CAR T Cells in Subjects With Relapsed/Refractory Embryonal Tumors (SABRE)
RECRUITING · Phase 1
-
Alpha/Beta T and B Cell Depletion With Zoledronic Acid for Solid Tumors
RECRUITING · Phase 1
-
Phase I Trial of rhIL-15 Plus Dinutuximab Plus Irinotecan/Temozolomide for Children and Young Adults With Relapsed/Refractory Neuroblastoma
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01269853 · 54 participants · Phase 1
Repeated Super-selective Intraarterial Cerebral Infusion of Bevacizumab (Avastin) for Treatment of Relapsed GBM and AA
- NCT02390752 · 54 participants · Phase 1
Phase I Trial of TURALIO(R) (Pexidartinib, PLX3397) in Children and Young Adults With Refractory Leukemias and Refractory Solid Tumors Including Neurofibromatosis Type 1 (NF1) Associated Plexiform Neurofibromas (PN) and Tenosynovial Giant Cell Tumor ...
- NCT02991248 · 54 participants · NA
Improve Dynamic Lateral Balance of Humans With SCI
- NCT02993900 · 54 participants · NA
Image-Guided Gynecologic Brachytherapy
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia