N2004-04: Fenretinide LXS in Treating Patients With Recurrent, Refractory, or Persistent Neuroblastoma
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00295919 |
Recruitment Status :
Completed
First Posted : February 24, 2006
Last Update Posted : February 15, 2016
|
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | February 23, 2006 | |||
First Posted Date ICMJE | February 24, 2006 | |||
Last Update Posted Date | February 15, 2016 | |||
Study Start Date ICMJE | December 2005 | |||
Actual Primary Completion Date | March 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
|
|||
Original Primary Outcome Measures ICMJE | Not Provided | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
|
|||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | N2004-04: Fenretinide LXS in Treating Patients With Recurrent, Refractory, or Persistent Neuroblastoma | |||
Official Title ICMJE | Phase I Study of Fenretinide (4-HPR, NSC 374551) Lym-X-Sorb™ (LXS) Oral Powder in Patients With Recurrent or Resistant Neuroblastoma | |||
Brief Summary | RATIONALE: Drugs used in chemotherapy, such as fenretinide LXS, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase I trial is studying the side effects and best dose of fenretinide LXS in treating patients with recurrent, refractory, or persistent neuroblastoma. |
|||
Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a dose-escalation study of fenretinide (4-HPR) Lym-X-Sorb™ (LXS) oral powder, followed by an open-label study. Patients are sequentially assigned to 1 of 2 intervention groups.
In both groups, treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity. Patients in complete remission at study enrollment may receive up to 12 courses (9 months) of therapy. Blood samples are collected at baseline and during courses 1, 2, and 6 for pharmacokinetic and correlative studies. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 32 patients will be accrued for the dose-escalation portion and 36 will be accrued for the open-label portion of this study. |
|||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
|||
Condition ICMJE | Neuroblastoma | |||
Intervention ICMJE |
|
|||
Study Arms ICMJE | Not Provided | |||
Publications * | Marachelian A, Kang MH, Hwang K, et al.: Phase I study of fenretinide (4-HPR) oral powder in patients with recurrent or resistant neuroblastoma: New Approaches to Neuroblastoma Therapy (NANT) Consortium trial. [Abstract] J Clin Oncol 27 (Suppl 15): A-10009, 2009. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Estimated Enrollment ICMJE |
68 | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date ICMJE | May 2015 | |||
Actual Primary Completion Date | March 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
|
|||
Sex/Gender ICMJE |
|
|||
Ages ICMJE | up to 30 Years (Child, Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00295919 | |||
Other Study ID Numbers ICMJE | CDR0000459787 P01CA081403 ( U.S. NIH Grant/Contract ) N2004-04 ( Other Identifier: NANT Consortium ) |
|||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Nant Operations Center, Children's Hospital Los Angeles | |||
Study Sponsor ICMJE | Children's Hospital Los Angeles | |||
Collaborators ICMJE | National Cancer Institute (NCI) | |||
Investigators ICMJE |
|
|||
PRS Account | Children's Hospital Los Angeles | |||
Verification Date | February 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |