N2007-03: Vorinostat and 131-I MIBG in Treating Patients With Resistant or Relapsed Neuroblastoma
RATIONALE: Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radioactive drugs, such as iobenguane I 131, may carry radiation directly to tumor cells and not harm normal cells. Giving vorinostat together with iobenguane I 131 may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of giving vorinostat together with iobenguane I 131 in treating patients with resistant or relapsed neuroblastoma.
Radiation: 131- I Metaiodobenzylguanidine
Procedure: Peripheral Blood Stem Cell Infusion
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Vorinostat With 131-I MIBG Therapy for Resistant/Relapsed Neuroblastoma: A Phase I Study IND# 105,744|
- All toxicities , including dose limiting toxicities, of the combination of vorinostat with therapeutic doses of 131-I MIBG [ Time Frame: From day 1 of vorinostat therapy to 56 days after stem cell re-infusion ] [ Designated as safety issue: Yes ]All toxicities observed will be summarized in terms of type (organ affected or laboratory determination), severity (by NCI CTCAE) and attribution. Tables will be created to summarize these toxicities and side effects by dose level and by course.
- Response evaluation , within the context of a phase I study. [ Time Frame: At study entry, 56 days after stem cell re-infusion (end of therapy). ] [ Designated as safety issue: No ]Eligible patients with measurable or evaluable disease who receive 131-I MIBG are evaluable for response even if they fail to complete the course of therapy because of disease progression. Responses will be described for all patients registered on the study even if there are major protocol deviations .
- Histone acetylation levels and norepinephrine transported mRNA levels in peripheral blood mononuclear cells after treatment with different doses of vorinostat. [ Time Frame: Baseline, Pre-day 3 , Post-day 3, Day 12, 13 or 14. ] [ Designated as safety issue: No ]Collection of samples for correlative biology is optional and not required for study entry. Although these studies are not mandated, all institutions are strongly urged to submit specimens for all consenting patients.
|Study Start Date:||March 2010|
|Estimated Study Completion Date:||May 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
- Suberoylanili de hydroxamic acid.
- 131-I MIBG
- Iobenguane I 131
- Peripheral blood stem cell transplant (PBSCT)
- Autologous bone marrow transplant (ABMT)
- Hemopoietic stem cell transplant (HSCT)
- To determine the maximum tolerated dose of vorinostat in combination with iobenguane I 131 in patients with resistant or relapsed neuroblastoma.
- To define the toxicities of vorinostat in combination with therapeutic doses of iobenguane I 131 in these patients.
- To describe, within the context of a phase I study, the response rate in patients treated with vorinostat and iobenguane I 131.
- To describe histone acetylation levels and norepinephrine transporter mRNA levels in peripheral blood mononuclear cells after treatment with different doses of vorinostat.
OUTLINE: This is a multicenter study.
Patients receive oral vorinostat once daily on days 1-14 and iobenguane I 131 IV over 1½-2 hours on day 3. Patients undergo autologous peripheral blood stem cell transplantation on day 17.
Blood samples may be collected periodically for correlative biological studies.
After completion of study treatment, patients are followed up periodically.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01019850
|United States, California|
|Children's Hospital Los Angeles|
|Los Angeles, California, United States, 90027|
|Lucile Salter Packer Children's Hospital|
|Palo Alto, California, United States, 94304|
|UCSF Helen Diller Family Comprehensive Cancer Center|
|San Francisco, California, United States, 94143|
|United States, Georgia|
|AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus|
|Atlanta, Georgia, United States, 30322|
|United States, Illinois|
|University of Chicago, Comer Children's Hospital|
|Chicago, Illinois, United States, 60637|
|United States, Massachusetts|
|Children's Hospital Boston|
|Boston, Massachusetts, United States, 02115|
|United States, Michigan|
|C.S Mott Children's Hospital|
|Ann Arbor, Michigan, United States, 48109|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229-3039|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104-4318|
|United States, Texas|
|Cook Children's Medical Center - Fort Worth|
|Fort Worth, Texas, United States, 76104|
|United States, Washington|
|Children's Hospital and Regional Medical Center - Seattle|
|Seattle, Washington, United States, 98105|
|Principal Investigator:||Steven DuBois, MD||UCSF Medical Center at Parnassus|