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.]

NCT02162732 : Molecular-Guided Therapy for Childhood Cancer
PhaseN/A
AgesMin: 13 Months Max: 21 Years
Eligibility
Inclusion Criteria:

1. Subjects must have proven pediatric cancer with confirmation at diagnosis or at the
time of recurrence/progression and clinical determination of disease for which there
is no known effective curative therapy or disease that is refractory to established
proven therapies fitting into one of the following categories:

- Neuroblastoma- Patients that have relapsed following standard of care therapy
(such as high risk patients, patient presenting after age 15 months or MYCN
amplified, and only following (for eligible patients) high-dose chemotherapy
followed by hematopoietic stem cell transplantation and maintenance therapy with
retinoic acid and antibody therapy) or having progressed during standard of care
therapy and non-responsive/progressive to accepted curative chemotherapy.

- Brain Tumors

- Medulloblastomas (At relapse after standard of care therapy [surgery,
chemotherapy and/or radiation] and/or non-responsive/progressive on accepted
curative therapy)

- Gliomas (At relapse after standard of care therapy [surgery and/or radiation
and/or chemotherapy] and/or non-responsive/progressive on accepted curative
therapy)

- Ependymomas (At relapse after standard of care therapy [surgery with or without
radiation] and/or non-responsive/progressive on accepted curative therapy)

- Choroid plexus tumors (At relapse after standard of care therapy [surgery] and/or
non-responsive/progressive on accepted curative therapy)

- Craniopharyngiomas (At relapse after standard of care therapy [surgery or
suppressive therapy] and/or non-responsive/progressive on accepted curative
therapy)

- Dysembryoplastic neuroepithelial tumors (DNETs) (At relapse after standard of
care therapy [surgery] and/or non-responsive/progressive on accepted curative
therapy)

- Meningiomas (At relapse after standard of care therapy [surgery] and/or
non-responsive/progressive on accepted curative therapy)

- Primitive Neuroectodermal Tumors (PNETs) (At relapse after standard of care
therapy [surgery, chemotherapy, and/or radiation] and/or
non-responsive/progressive on accepted curative therapy)

- Germ cell tumors (At relapse after standard of care therapy [surgery, and/or
radiation and/or chemotherapy] and/or non-responsive/progressive on accepted
curative therapy)

- Rare Tumors:

- Soft tissue sarcoma Rhabdomyosarcoma (At relapse after standard of care therapy
[surgery, and/or radiation, chemotherapy] and/or non-responsive/progressive to
accepted curative chemotherapy) Non-rhabdomyosarcoma (At relapse after standard
of care therapy [surgery, and/or radiation, chemotherapy] and/or
non-responsive/progressive to accepted curative chemotherapy)

- Bone Ewings sarcoma (At relapse after standard of care therapy [surgery, and/or
radiation, chemotherapy] and/or non- responsive/progressive to accepted curative
chemotherapy) Osteosarcoma (At relapse after standard of care therapy [surgery,
chemotherapy] and/or non- responsive/progressive to accepted curative
chemotherapy)

- Renal Wilms tumor (At relapse after standard of care therapy [surgery, and/or
radiation, chemotherapy] and/or non- responsive/progressive to accepted
chemotherapy) Renal cell carcinoma (At relapse after standard of care therapy
[surgery, chemotherapy] and/or non- responsive/progressive to accepted curative
chemotherapy) Malignant rhabdoid tumor (At diagnosis, as there is no known
curative therapy) Clear Cell Sarcoma- (At relapse after standard of care therapy
[radiation, chemotherapy] and/or non- responsive/progressive to accepted curative
chemotherapy) Germ Cell tumors (At relapse after standard of care therapy
[surgery, chemotherapy] and/or non-responsive/progressive to accepted curative
chemotherapy)

- Liver Tumors (At relapse after standard of care therapy [surgery, chemotherapy]
and/or non- responsive/progressive to accepted curative chemotherapy)

2. Subjects must be age >12 months at enrollment

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

4. Subjects must have measurable disease as demonstrated by residual abnormal tissue at a
primary or metastatic site (measurable on CT or MRI) at the time of biopsy; tumor must
be accessible for biopsy. In addition, subjects with bone or bone marrow only disease
expected to be >75% tumor are eligible to enroll.

5. Current disease state must be one for which there is currently no known effective
therapy

6. Specimens will be obtained only in a non-significant risk manner and not solely for
the purpose of investigational testing.

7. Lansky or Karnofsky Score must be ? 50

8. Subjects without bone marrow metastases must have an ANC > 750/?l to begin treatment.

9. Subjects with CNS disease must have been on a stable dose of steroids for 2 weeks
prior to their biopsy and must not have progressive hydrocephalus at enrollment.

10. Adequate liver function must be demonstrated, defined as:

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

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

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

12. 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.

13. Informed Consent: All subjects and/or legal guardians must sign informed written
consent. Assent, when appropriate, will be obtained according to institutional
guidelines

Exclusion Criteria:

1. Subjects who have received any cytotoxic chemotherapy within the last 7 days prior to
biopsy

2. 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).

3. Subjects receiving any investigational drug concurrently.

4. Subjects with uncontrolled serious infections or a life-threatening illness (unrelated
to tumor)

5. 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=NCT02162732      |      Link to official Clinicaltrials.gov listing
Locations
Beirut,
Lebanon

Facility: American University of Beirut Medical Center
Investigator: Raya Saab, MD
Contact: Zeina Merabi
Click HERE to send email to this center

Little Rock, Arkansas
Facility: Arkansas Children's Hospital
Investigator: Kathleen Neville, MD
Contact: Janet Storment, RN Phone: 501-364-2760
Click HERE to send email to this center

San Diego, California
Facility: Rady Children's Hospital
Investigator: William Roberts, MD
Contact: Mehrzad Milburn Phone: 858-966-8155
Email not avaialable

Hartford, Connecticut
Facility: Connecticut Children's Hospital
Investigator: Michael Isakoff, MD
Contact: Sharon Huie-White Phone: 860-545-9337
Click HERE to send email to this center

Orlando, Florida
Facility: Arnold Palmer Hospital for Children
Investigator: Don Eslin, MD
Contact: Janice Hendrix Phone: 321-841-8588
Click HERE to send email to this center

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: Deanna Mitchell, MD
Contact: Shannon MacKeigan Phone: 616-267-1162
Click HERE to send email to this center

Minneapolis, Minnesota
Facility: Children's Hospital and Clinics on Minnesota
Investigator: Jawhar Rawwas, MD
Contact: Courtney Haller Phone: 612-813-5913
Click HERE to send email to this center

Kansas City, Missouri
Facility: Children's Mercy Hospitals and Clinics
Investigator: Keith August, MD
Contact: Michelle Dinkins Phone: 816-302-6893
Click HERE to send email to this center

Saint 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: Elizabeth Arroyo-Green Phone: 980-442-2312
Click HERE to send email to this center

Portland, Oregon
Facility: Randall Children's Hospital
Investigator: Jason Glover, MD
Contact: Aaron White
Click HERE to send email to this center

Hershey, Pennsylvania
Facility: Penn State Milton S. Hershey Medical Center and Children's Hospital
Investigator: Valerie Brown, MD
Contact: Suzanne Treadway
Click HERE to send email to this center

Charleston, South Carolina
Facility: Medical University of South Carolina
Investigator: Jaqueline Kraveka, MD
Contact: Jacqueline Kraveka, MD Phone: 843-792-2957
Email not avaialable

Nashville, Tennessee
Facility: Monroe Carrell Jr. Children's Hospital at Vanderbilt
Investigator: Devang Pastakia, MD
Contact: Natalie Resczenko Phone: 615-936-1522
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




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