Phase
Condition
Neoplasms
Neuroblastoma
Treatment
N/AClinical Study ID
Ages > 1 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Subjects with a diagnosis of iobenguane avid, high-risk neuroblastoma based on RevisedINRC criteria at the time of study enrollment with recurrent or progressive disease atany time prior to enrollment, regardless of overall response to frontline therapy,where frontline therapy includes a minimum of 4 cycles of induction therapy at anytime prior to enrollment.
- May have had prior 131I-MIBG therapy, provided:
- It has been at least 6 months from the date of last 131I-MIBG ;
- Response was other than progressive disease on first restaging after 131I-MIBG ;
- Prior 131I-MIBG was given as monotherapy and not in combination with systemicanticancer agents;
- Cumulative lifetime dose of 131I-MIBG at enrollment does not exceed 18 mCi/kg.
- All soft tissue lesions identified on CT/MRI scans must be iobenguane avid lesions onan (123I)-iobenguane scan, or
- any progressive non-iobenguane avid lesion is proven by biopsy to be anon-neuroblastoma lesion.
- any other non-avid lesion is comprised of a fibrotic or scarred mass as shown byroutine imaging and confirmed by the investigator.
- Adequate cryopreserved autologous peripheral blood stem cells or bone marrow (at least 2 aliquots of 2.0 × 10exp6 CD34/kg at the time of study enrollment).
- If a male, must agree to use an adequate contraception method as deemed appropriate bythe Investigator (e.g., vasectomy, condoms) or partner using effective contraceptionand to not donate sperm during the study and for 90 days after receiving the last doseof study drug.
- If a female of childbearing potential, have a negative serum pregnancy test resultprior to each dosing and, if sexually active, be practicing an effective method ofbirth control [e.g., intrauterine device, double-barrier method (i.e., diaphragm, or acervical cap) with intravaginal spermicidal foam, cream or gel], or male partnersterilization throughout the study.
- Age at study entry ≥1 year.
- Previous platelet transfusions are permitted, as long as the subject has a plateletcount ≥50,000/μL without transfusion support for at least 1 week.
- Subjects must have a minimum pulse oximetry measurement of at least 94% at baseline.
- An absolute neutrophil count ≥750/μL without growth factor for 5 days.
- Liver function parameter results: total bilirubin ≤2 × upper limit of normal for age,and Serum alanine aminotransferase (glutamic-pyruvic transaminase) and serum aspartateaminotransferase (glutamic-oxaloacetic transaminase) ≤ 10 times the upper limit ofnormal (for all sites, the upper limit of normal for alanine aminotransferase isdefined as 45 U/L).
- Normal thyroid function as measured by T4 or TSH or have abnormal results that are notconsidered clinically important by the Investigator or may be receiving levothyroxine.
- Cardiac Function: shortening fraction of ≥ 27% by echocardiogram or ejection fraction ≥ 50% documented by echocardiogram or radionuclide angiogram within 1 month prior toVisit 1 (Baseline).
- Karnofsky Performance Status (for subjects >16 years of age) or the Lansky PerformanceStatus Performance Status (for subjects 1 to 16 years of age) ≥50%.
- Full recovery from the toxic effects of any prior therapy.
- Coagulation Function:
- International Normalized Ratio (INR) < 1.5
- Partial thromboplastin time (PTT) < 1.5 times upper limit of normal.
Exclusion
Exclusion Criteria:
- Subjects within 5 half-lives after any antibody-based immunotherapy, or have notrecovered from effects of any biologic therapy.
- Subjects <12 weeks after myeloablative therapy with autologous stem cell transplant.
- Subjects who have had an allogeneic stem cell treatment less than 4 months from Visit 1 are excluded. Those who have received allogeneic stem cell treatment more than 4months from Visit 1 must have recovered and have no active graft versus host disease (GVHD) to be eligible.
- Subjects must not have received radiation for a minimum of 2 weeks prior to studyenrollment. Subjects whose only site(s) of disease have been radiated are eligible aslong as the subject has MIBG avidity 2 weeks after completion of radiation. A minimumof 12 weeks prior to study enrollment is required following prior large fieldradiation therapy (ie, craniospinal, whole abdominal, total lung, > 50% marrow space)
- History of total body irradiation.
- Subjects do not have adequate renal function defined as GFR ≥ 70 mL/min/1.73 m2 eitherby creatinine clearance or radioisotope direct measurement or by calculation with theSchwartz formula
- Subjects who are on hemodialysis.
- Pregnancy or breastfeeding.
- Significant active infections including active hepatitis B, or hepatitis C infection,or known infection with human immunodeficiency virus (HIV) (testing for HIV is notrequired prior to study entry).
- Clinically important cardiac, pulmonary, and hepatic impairment.
- Vorinostat treatment exclusion criteria (subjects, who meet any one of these criteriaand otherwise meet eligibility criteria, are still eligible for 131I-MIBG monotherapy)
- Since valproic acid has HDAC inhibitory activity, patients must not have receivedvalproic acid within 30 days of study entry.
- Since vorinostat may prolong the QT interval, patients must not be receivingother medications known to prolong the QT interval at the time of study entry .Pentamidine must not have been received within 1 week of study enrollment.
- Patients with a history of deep venous thrombosis that was not associated withthe presence of a central venous catheter.
- Patients who are receiving Coumadin.
Study Design
Study Description
Connect with a study center
Stanford University
Palo Alto, California 94304
United StatesSite Not Available
UCSF Pediatric Hematology/Oncology
San Francisco, California 94158
United StatesActive - Recruiting
Children's Hospital Colorado
Aurora, Colorado 80045
United StatesActive - Recruiting
Nemours Children's Specialty Care
Jacksonville, Florida 32207
United StatesActive - Recruiting
University of Chicago Medical Center
Chicago, Illinois 60637
United StatesActive - Recruiting
University of Iowa Hospitals and Clinics
Iowa City, Iowa 52242
United StatesActive - Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United StatesActive - Recruiting
University of Minnesota
Minneapolis, Minnesota 55455
United StatesActive - Recruiting
Washington University Medical Center in St. Louis
Saint Louis, Missouri 63110
United StatesActive - Recruiting
Northwell Health /Cohen Children's Medical Center
New Hyde Park, New York 11040
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesActive - Recruiting
Carolinas Medical Center/Levine Children's Hospital (Atrium Health)
Charlotte, North Carolina 28203
United StatesActive - Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
United StatesActive - Recruiting
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania 15224
United StatesActive - Recruiting
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania 15224
United StatesActive - Recruiting
University of Texas Southwestern Medical Center, Children's Health
Dallas, Texas 75235
United StatesActive - Recruiting
Cook Children's Hematology/Oncology Center
Fort Worth, Texas 76104
United StatesActive - Recruiting
Texas Children's Hospital
Houston, Texas 77030
United StatesActive - Recruiting
Seattle Children's Hospital
Seattle, Washington 98105
United StatesActive - Recruiting
University of Wisconsin, American Family Children's Hospital and Clinical Science Center
Madison, Wisconsin 53792
United StatesActive - Recruiting
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