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A Phase II Preventative Trial of DFMO as a Single Agent in Patients With High Risk Neuroblastoma in Remission


Phase 2
N/A
21 Years
Open (Enrolling)
Both
Neuroblastoma in Remission

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Trial Information

A Phase II Preventative Trial of DFMO as a Single Agent in Patients With High Risk Neuroblastoma in Remission


Inclusion Criteria:



- Age: 0-21 years at the time of diagnosis.

- Diagnosis: histologic verification at either the time of original diagnosis or a
previous relapse of high risk neuroblastoma.

- Disease Status: Neuroblastoma that is in remission (defined as no evidence of disease
that is >1cm on radiological assessment)

- Greater than 30 days from completion of cytotoxic and biologic therapy and less than
120 days from previous therapy.

- A negative urine pregnancy test is required for female subjects of child bearing
potential (onset of menses or ≥13 years of age).

- 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.

- ANC > 500/μl and platelet count >50,000/μl

- Organ Function Requirements: Subjects must have adequate liver function as defined
by:

- AST and ALT <10x upper limit of normal

- Serum bilirubin must be ≤ 2.0 mg/dl

- Serum creatinine must be ≤ 3 mg/dl

- 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:

- Lansky score < 60%

- BSA (m2) of <0.25

- Investigational Drugs: Subjects who are currently receiving another investigational
drug are excluded from participation.

- Anti-cancer Agents: Subjects who are currently receiving other anticancer agents are
not eligible. Subjects must have fully recovered from the effects of prior
chemotherapy (hematological and bone marrow suppression effects).

- Infection: Subjects who have an uncontrolled infection are not eligible until the
infection is judged to be well controlled in the opinion of the investigator.

- Subjects who, in the opinion of the investigator, may not be able to comply with the
safety monitoring requirements of the study, or in whom compliance is likely to be
suboptimal, should be excluded.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

To evaluate the preventative activity of DFMO as a single agent in patients that are in remission based on: Event free survival (EFS)

Outcome Description:

3.1.1 To evaluate the preventative activity of DFMO as a single agent in patients that are in remission based on: Event free survival (EFS)

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Giselle Sholler, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Van Andel Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

NMTRC 003

NCT ID:

NCT01586260

Start Date:

June 2012

Completion Date:

June 2020

Related Keywords:

  • Neuroblastoma in Remission
  • Neuroblastoma
  • Relapsed Neuroblastoma
  • Refractory Neuroblastoma
  • Neuroblastoma

Name

Location

Medical University of South CarolinaCharleston, South Carolina  29425-0721
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Phoenix Children's HospitalPhoenix, Arizona  85016-7710
Kapiolani Medical Center for Women and ChildrenHonolulu, Hawaii  96826
Children's Mercy Hospitals and ClinicsKansas City, Missouri  64108
Rady Children's HospitalSan Diego, California  92123
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
Texas Children's Cancer and Hematology CentersHouston, Texas  77030
Dell Children's Blood and Cancer CenterAustin, Texas  78723
Primary Children's HospitalSalt Lake City, Utah  84113