Vorinostat With 131-I MIBG Therapy for Resistant/Relapsed Neuroblastoma: A Phase I Study IND# 105,744
- 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
Blood samples may be collected periodically for correlative biological studies.
After completion of study treatment, patients are followed up periodically.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
All toxicities , including dose limiting toxicities, of the combination of vorinostat with therapeutic doses of 131-I MIBG
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.
From day 1 of vorinostat therapy to 56 days after stem cell re-infusion
Steven DuBois, MD
UCSF Medical Center at Parnassus
United States: Food and Drug Administration
|Children's Hospital of Philadelphia||Philadelphia, Pennsylvania 19104|
|Children's Hospital Los Angeles||Los Angeles, California 90027-0700|
|Children's Hospital and Regional Medical Center - Seattle||Seattle, Washington 98105|
|Cook Children's Medical Center - Fort Worth||Fort Worth, Texas 76104|
|Texas Children's Cancer Center||Houston, Texas 77030-2399|
|Cincinnati Children's Hospital Medical Center||Cincinnati, Ohio 45229-3039|
|UCSF Helen Diller Family Comprehensive Cancer Center||San Francisco, California 94115|
|Children's Hospital Boston||Boston, Massachusetts 02115|
|Duke University Medical Center||Durham, North Carolina 27710|
|Children's Healthcare of Atlanta||Atlanta, Georgia 30342|
|C.S Mott Children's Hospital||Ann Arbor, Michigan 48109|
|Lucile Salter Packer Children's Hospital||Palo Alto, California 94304|
|University of Chicago, Comer Children's Hospital||Chicago, Illinois 60637|