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A Feasibility Trial Using Molecular-Guided Therapy for the Treatment of Patients With Refractory or Recurrent Neuroblastoma


N/A
1 Year
N/A
Open (Enrolling)
Both
Neuroblastoma

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Trial Information

A Feasibility Trial Using Molecular-Guided Therapy for the Treatment of Patients With Refractory or Recurrent Neuroblastoma


Inclusion Criteria:



- Patients must have histologically proven neuroblastoma and confirmation of refractory
or recurrent disease with histologic confirmation at diagnosis or at the time of
recurrence/progression

- Patients must be age > 12 months and ≤ 21 at initial diagnosis.

- Life expectancy must be more than 3 months

- If measurable disease, this must be 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% are eligible to enroll.

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

- Lansky or KarnofskyScore must be more than 50

- Patients without bone marrow metastases must have an ANC > 750/μl and platelet count
> 50,000/μl

- Adequate liver function must be demonstrated, defined as:

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

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

- No other significant organ toxicity defined as > Grade 2 by National Cancer Institute
Common Toxicity Criteria for Adverse Events NCI-CTCAE V4.0

- 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 patients 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:

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

- Patients who have received any radiotherapy within the last 30 days must have another
site of disease to follow.

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

- Patients 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.

- Patients 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 patient's ability
to sign or the legal guardian's ability to sign the informed consent, and patient's
ability to cooperate and participate in the study

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Determine feasibility of using predictive modeling based on genome-wide mRNA expression profiles

Outcome Description:

Determine feasibility of using predictive modeling based on genome-wide mRNA expression profiles of bone marrow derived neuroblastoma cells or tumor biopsies to make real-time treatment decisions.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Giselle Sholler, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Van Andel Research Instititute

Authority:

United States: Food and Drug Administration

Study ID:

NMTRC 001

NCT ID:

NCT01355679

Start Date:

May 2011

Completion Date:

December 2013

Related Keywords:

  • Neuroblastoma
  • Neuroblastoma

Name

Location

Children's Mercy Hospitals and ClinicsKansas City, Missouri  64108
National Cancer InstituteBethesda, Maryland  20892-1922
Connecticut Children's HospitalHartford, Connecticut  06106
Arnold Palmer Hospital for Children- MD AndersonOrlando, Florida  32806
Helen DeVos Children's HospitalGrand Rapids, Michigan  49503
Cardinal Glennon Children's Medical CenterSt. Louis, Missouri  63104
Levine Children's HospitalCharlotte, North Carolina  28204