Neuroblastoma Maintenance Therapy Trial
Status: | Recruiting |
---|---|
Conditions: | Brain Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 1 - 30 |
Updated: | 2/17/2018 |
Start Date: | February 2016 |
End Date: | February 2025 |
Contact: | Genevieve Bergendahl, MSN |
Email: | genevieve.bergendahl@helendevoschildrens.org |
Phone: | 6162670335 |
NMTT- Neuroblastoma Maintenance Therapy Trial Using Difluoromethylornithine (DFMO)
Difluoromethylornithine (DFMO) will be used in an open label, single agent, multicenter,
study for patients with neuroblastoma in remission. In this study subjects will receive 730
Days of oral difluoromethylornithine (DFMO) at a dose of 500 to 1000 mg/m2 BID on each day of
study. This study will focus on the use of DFMO in high risk neuroblastoma patients that are
in remission as a strategy to prevent recurrence.
study for patients with neuroblastoma in remission. In this study subjects will receive 730
Days of oral difluoromethylornithine (DFMO) at a dose of 500 to 1000 mg/m2 BID on each day of
study. This study will focus on the use of DFMO in high risk neuroblastoma patients that are
in remission as a strategy to prevent recurrence.
Inclusion Criteria:
- All patients must have a pathologically confirmed diagnosis of neuroblastoma, < 30.99
years of age and classified as high risk at the time of diagnosis. Exception: patients
who are initially diagnosed as non-high-risk neuroblastoma, but later converted
(and/or relapsed) to high risk neuroblastoma are also eligible.
- All patients must be in complete remission (CR):
1. No evidence of residual disease on scan
2. No evidence of disease metastatic to bone marrow.
- Specific Criteria by Stratum:
Stratum 1: All patients must have completed standard upfront therapy that replicates
treatment which patients who were enrolled on ANBL0032 received, including:
intensive induction chemotherapy and (if feasible) resection of primary tumor, followed by:
consolidation with high-dose chemotherapy with stem cell transplant and radiotherapy,
followed by: immunotherapy with Ch14.18/IL-2/GM-CSF (dinutuximab) and retinoic acid;.
All subjects on Stratum 1 must have also met the following criteria:
• A pre-transplant disease status evaluation that met International Neuroblastoma Response
Criteria (INRC) for CR (complete response), VGPR (very good partial response), or PR
(partial response) for primary site, soft tissue metastases and bone metastases. Patients
who meet those criteria must also meet the protocol-specified criteria for bone marrow
response prior to transplant as outlined below: No more than 10% tumor involvement (based
on total nucleated cellular content) seen on any specimen from a bilateral bone marrow
aspirate/biopsy.
Stratum 2: Neuroblastoma that is in first complete remission following standard upfront
therapy different from that described for Stratum 1.
Stratum 3: Neuroblastoma that failed to have a response of at least PR following induction
chemotherapy and surgical resection of the primary tumor, but that has achieved CR
following additional therapy.
Stratum 4: Patients who have achieved a second or subsequent CR following relapse(s).
- Pre-enrollment tumor survey: Prior to enrollment on this study, a determination of
mandatory disease staging must be performed:
- Tumor imaging studies including
- Bilateral bone marrow aspirates and biopsy
- This disease assessment is required for eligibility and preferably should be done
within 2 weeks prior to enrollment, but must be done within a maximum of 4 weeks
before enrollment.
- Timing from prior therapy:
Stratum 1: Enrollment no later than 60 days after completion of upfront therapy, (last dose
of cis-retinoic acid) with a maximum of 6 cycles of cis-retinoic acid maintenance therapy.
Stratum 2, 3 and 4: Enrollment no later than 60 days from last dose of the most recent
therapy.
- Patients must have a Lansky or Karnofsky Performance Scale score of > 50% and patients
must have a life expectancy of ≥ 2 months.
- All clinical and laboratory studies for organ functions to determine eligibility must
be performed within 7 days prior to enrollment unless otherwise indicated below.
- Patients must have adequate organ functions at the time of registration:
- Hematological: Total absolute phagocyte count ≥1000/μL
- Liver: Subjects must have adequate liver function
- Renal: Adequate renal function
- Females of childbearing potential must have a negative pregnancy test. Patients of
childbearing potential must agree to use an effective birth control method. Female
patients who are lactating must agree to stop breast-feeding.
- Written informed consent in accordance with institutional and FDA (food and drug
administration) guidelines must be obtained from all subjects (or patients' legal
representative).
Exclusion Criteria:
- BSA (Body Surface Area) of <0.25 m2.
- 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 hematological and bone marrow
suppression effects of prior chemotherapy.
- 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.
We found this trial at
31
sites
800 Washington St
Boston, Massachusetts 02111
Boston, Massachusetts 02111
(617) 636-5000
![Tufts Medical Center](/wp-content/uploads/logos/tufts-medical-center.jpg)
Principal Investigator: Michael Kelly, MD
Phone: 617-636-8885
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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700 Childrens Drive
Columbus, Ohio 43205
Columbus, Ohio 43205
(616) 722-2000
![Nationwide Children's Hospital](/wp-content/uploads/logos/nationwide-children-s-hospital.png)
Principal Investigator: Keri Streby, MD
Phone: 614-722-6039
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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601 Children's Lane
Norfolk, Virginia 23507
Norfolk, Virginia 23507
(757) 668-7000
![Children's Hospital of The King's Daughters](/wp-content/uploads/logos/children-s-hospital-of-the-king-s-daughters.gif)
Principal Investigator: Eric Lowe, MD
Children's Hospital of The King's Daughters Children
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1120 15th Street
Augusta, Georgia 30912
Augusta, Georgia 30912
Principal Investigator: Coleen McDonough, MD
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Austin, Texas 78723
Principal Investigator: Virginia Harrod, MD
Phone: 512-628-1902
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1208 3rd Avenue South
Birmingham, Alabama 35233
Birmingham, Alabama 35233
Principal Investigator: Elizabeth Alva, MD
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171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
![Medical University of South Carolina](/wp-content/uploads/logos/medical-university-of-south-carolina.jpg)
Principal Investigator: Jaqueline Kraveka, MD
Phone: 843-792-2957
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charlotte, North Carolina 28204
Principal Investigator: Javier Oesterheld, MD
Phone: 980-442-2312
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836 West Wellington Avenue
Chicago, Illinois 60657
Chicago, Illinois 60657
Principal Investigator: Jason Canner, MD
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Dallas, Texas 75235
Principal Investigator: Ted Laetsch, MD
Phone: 214-456-0004
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Grand Rapids, Michigan 49503
Principal Investigator: Deanna Mitchell, MD
Phone: 616-267-0334
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30 Prospect Ave
Hackensack, New Jersey 07601
Hackensack, New Jersey 07601
(201) 996-2000
![Hackensack University Medical Center](/wp-content/uploads/logos/hackensack-university-medical-center.jpg)
Principal Investigator: Derek Hanson, MD
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Hartford, Connecticut 06106
Principal Investigator: Michael Isakoff, MD
Phone: 860-545-9337
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Hershey, Pennsylvania 17033
Principal Investigator: Valerie Brown, MD
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1319 Punahou St
Honolulu, Hawaii 96826
Honolulu, Hawaii 96826
(808) 983-6000
![Kapiolani Medical Center for Women and Children](/wp-content/uploads/logos/kapiolani-medical-center-for-women-and-children.jpg)
Principal Investigator: Randal Wada, MD
Phone: 808-535-7169
Kapiolani Medical Center for Women and Children Hawai‘i Pacific Health is an integrated health care...
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Houston, Texas 77030
Principal Investigator: Peter Zage, MD, PhD
Phone: 832-824-4393
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Kansas City, Missouri 64108
Principal Investigator: Keith August, MD
Phone: 816-302-6893
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1 Children's Way
Little Rock, Arkansas 72202
Little Rock, Arkansas 72202
(501) 364-1100
![Arkansas Children's Hospital](/wp-content/uploads/logos/arkansas-children-s-hospital.jpg)
Principal Investigator: Kathleen Neville, MD
Phone: 501-364-2760
Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...
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Minneapolis, Minnesota 55404
Principal Investigator: Jawhar Rawwas, MD
Phone: 612-813-5913
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Nashville, Tennessee 37232
Principal Investigator: Devang Pastakia, MD
Phone: 615-936-1522
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70 Washington Square S
New York, New York 10012
New York, New York 10012
(212) 998-1212
![New York University](/wp-content/uploads/logos/new-york-university.jpg)
Principal Investigator: Sharon Gardner, MD
New York University More than 175 years ago, Albert Gallatin, the distinguished statesman who served...
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Oakland, California 94609
Principal Investigator: Anurag Agrawal, MD
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Orlando, Florida 32806
Principal Investigator: Don Eslin, MD
Phone: 321-841-8588
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1919 E Thomas Rd
Phoenix, Arizona 85006
Phoenix, Arizona 85006
(602) 933-1000
![Phoenix Children's Hospital](/wp-content/uploads/logos/phoenix-children-s-hospital.jpg)
Principal Investigator: Francis Eshun, MD
Phone: 602-546-0211
Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
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Saint Louis, Missouri 63104
Principal Investigator: William Ferguson, MD
Phone: 314-268-4000
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Saint Petersburg, Florida 33701
Principal Investigator: Gregory Hale, MD
Phone: 727-767-2428
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Salt Lake City, Utah 84143
Principal Investigator: Mark Fluchel, MD
Phone: 801-662-4710
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San Diego, California 92123
Principal Investigator: William Roberts, MD
Phone: 858-966-8155
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