Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01802567 : Molecular-Guided Therapy for Relapsed and Refractory Childhood Cancer
PhaseN/A
AgesMin: 13 Months Max: N/A
Eligibility
Inclusion Criteria:

- Subjects must have histologically proven neuroblastoma, brain tumor, or rare tumor
and confirmation of refractory or recurrent disease with histologic confirmation at
diagnosis or at the time of recurrence/progression

- Subjects must be age >12 months at enrollment.

- Subjects must be age ? 21 years at initial diagnosis.

- Subjects must have measurable disease as demonstrated by residual abnormal tissue at
a primary or metastatic site measuring more than 1 cm in any dimension by
standardized imaging (CT or MRI); tumor must be accessible for biopsy. Patients with
bone marrow only disease expected to be >75% tumor are eligible to enroll.

- Current disease state must be one for which there is currently no known curative
therapy

- Lansky or Karnofsky Score must be more than 50

- Subjects without bone marrow metastases must have an ANC > 750/?l

- Adequate liver function must be demonstrated, defined as:

1. Total bilirubin ? 1.5 x upper limit of normal (ULN) for age AND

2. SGPT (ALT) < 10 x upper limit of normal (ULN) for age

- A negative serum pregnancy test is required for female participants of child bearing
potential (?13 years of age or after onset of menses)

- Both male and female post-pubertal study subjects need to agree to use one of the
more effective birth control methods during treatment and for six months after
treatment is stopped. These methods include total abstinence (no sex), oral
contraceptives ("the pill"), an intrauterine device (IUD), levonorgestrol implants
(Norplant), or medroxyprogesterone acetate injections (Depo-provera shots). If one of
these cannot be used, contraceptive foam with a condom is recommended.

- Informed Consent: All subjects and/or legal guardians must sign informed written
consent. Assent, when appropriate, will be obtained according to institutional
guidelines. Voluntary consent for optional biology studies will be included.

Exclusion Criteria:

- Subjects who have received any cytotoxic chemotherapy within the last 7 days prior to
enrollment and 14 days prior to study treatment start date.

- Subjects who have received any radiotherapy to the primary sample site within the
last 14 days (radiation may be included in treatment decision after biopsy).

- Subjects receiving anti-tumor therapy for their disease or any investigational drug
concurrently

- Subjects with serious infection or a life-threatening illness (unrelated to tumor)
that is > Grade 2 (NCI CTCAE V4.0), or active, serious infections requiring
parenteral antibiotic therapy.

- Subjects with any other medical condition, including malabsorption syndromes, mental
illness or substance abuse, deemed by the Investigator to be likely to interfere with
the interpretation of the results or which would interfere with a subject's ability
to sign or the legal guardian's ability to sign the informed consent, and subject's
ability to cooperate and participate in the study
LinksPermanent Link to THIS page: http://virtualtrials.com/nct/display1trial.cfm?nct=NCT01802567      |      Link to official Clinicaltrials.gov listing
Locations
San Diego, California
Facility: Rady Children's Hospital
Investigator: William Roberts, MD
Contact: Mehrzad Milburn Phone: 858-966-8155
Click HERE to send email to this center

Hartford, Connecticut
Facility: Connecticut Children's Hospital
Investigator: Nehal Parikh, MD
Contact: Jennifer Hylton Phone: 860-545-9337
Click HERE to send email to this center

Orlando, Florida
Facility: Arnold Palmer Hospital for Children- MD Anderson
Investigator: Don Eslin, MD
Contact: Michelle Pope, RN Phone: 321-841-8588
Email not avaialable

Honolulu, Hawaii
Facility: Kapiolani Medical Center for Women and Children
Investigator: Randal Wada, MD
Contact: Andrea Siu, MPH Phone: 808-535-7169
Click HERE to send email to this center

Grand Rapids, Michigan
Facility: Helen DeVos Children's Hospital
Investigator: Giselle Sholler, MD
Contact: Shannon Mackeigan Phone: 616-267-1162
Click HERE to send email to this center

Kansas City, Missouri
Facility: Children's Mercy Hospitals and Clinics
Investigator: Kathleen Neville, MD
Contact: Sara Soliman, RN Phone: 816-855-1977
Click HERE to send email to this center

St. Louis, Missouri
Facility: Cardinal Glennon Children's Medical Center
Investigator: William Ferguson, MD
Contact: Katherine Maxwell, RN Phone: 314-268-4000
Email not avaialable

Charlotte, North Carolina
Facility: Levine Children's Hospital
Investigator: Javier Oesterheld, MD
Contact: Nicole Turner, RN Phone: 980-442-2355
Click HERE to send email to this center

Charleston, South Carolina
Facility: Medical University of South Carolina
Investigator: Jaqueline Kraveka, MD
Contact: Kate McCormack, RN Phone: 843-792-3379
Click HERE to send email to this center

Austin, Texas
Facility: Dell Children's Blood and Cancer Center
Investigator: Sharon Lockhart, MD
Contact: Letitia Holden, RN Phone: 512-628-1902
Click HERE to send email to this center

Salt Lake City, Utah
Facility: Primary Children's Hospital
Investigator: Mark Fluchel, MD
Contact: Lisa Smith Phone: 801-662-4710
Click HERE to send email to this center




Home | Brain Tumor Guide | FAQs | Find A Treatment
Noteworthy Treatments | News | Virtual Trial | Videos | Novocure Optune® | Newsletter
Donations | Brain Tumor Centers | Survivor Stories | Temodar®
Fundraising For Research | Unsubscribe | Contact Us

Copyright (c) 1993 - 2017 by:
The Musella Foundation For Brain Tumor Research & Information, Inc
1100 Peninsula Blvd
Hewlett, NY 11557
888-295-4740


Website Design By
World Wide Websites