RECRUITING

Eflornithine (DFMO) and Etoposide for Relapsed/Refractory Neuroblastoma

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Difluoromethylornithine (DFMO) will be used in an open label, multicenter, study in combination with etoposide for subjects with relapsed/refractory neuroblastoma.

Official Title

Phase II Trial of Eflornithine (DFMO) and Etoposide for Relapsed/Refractory Neuroblastoma

Quick Facts

Study Start:2020-09-25

Study Completion:2033-10-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04301843

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 31 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
* All patients must have a pathologically confirmed diagnosis of neuroblastoma, ≤ 30.99 years of age with history of relapsed/refractory neuroblastoma. * All patients must have completed upfront therapy with at least 4 cycles of aggressive multi-drug chemotherapy. * Specific Criteria by Arm: * Timing from prior therapy: Enrollment (first dose of DFMO) no later than 60 days from last dose of the most recent therapy. * Subjects must have fully recovered from the acute toxic effects of all prior anti- cancer chemotherapy and be within the following timelines: 1. Myelosuppressive chemotherapy: Must not have received within 2 weeks of enrollment onto this study (6 weeks if prior nitrosourea). 2. Hematopoietic growth factors: At least 5 days since the completion of therapy with a growth factor. 3. Biologic (anti-neoplastic agent): At least 7 days since the completion of therapy with a biologic agent. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the Study Chair. 4. Immunotherapy: At least 6 weeks since the completion of any type of immunotherapy, e.g. tumor vaccines, CAR-T cells. 5. Anti-GD2 Monoclonal antibodies: At least 2 weeks must have elapsed since prior treatment with a monoclonal antibody. 6. XRT: At least 14 days since the last treatment except for radiation delivered with palliative intent to a non-target site. 7. Stem Cell Transplant: 1. Allogeneic: No evidence of active graft vs. host disease 2. Allo/Auto: ≥ 2 months must have elapsed since transplant. 8. MIBG Therapy: At least 8 weeks since treatment with MIBG therapy * Subjects must have a Lansky or Karnofsky Performance Scale score of 60% or higher. * Life expectancy \> 2 months * All clinical and laboratory studies for organ functions to determine eligibility must be performed within 7 days prior to first dose of study drug unless otherwise indicated below. * Subjects must have adequate organ functions at the time of registration: * Hematological: Total absolute neutrophil count ANC ≥750/μL * Liver: Subjects must have adequate liver function as defined by AST and ALT \<5x upper limit of normal (Normal=45), Bilirubin \<1.5x upper limit normal (Normal=1.0). Normal PT, PTT, fibrinogen. * Renal: Adequate renal function defined as (perform one of the following): Creatinine clearance or radioisotope GFR 70 mL/min/1.73 m2 or greater or a serum creatinine based on age/gender * 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 guidelines must be obtained from all subjects (or patients' legal representative).	* BSA of \<0.25 m2. * Subjects that received DFMO at a dose higher than 1000mg/m2 BID prior to this study are not eligible. * Subjects that received a dose of DFMO in combination with etoposide are not eligible. * 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.

Inclusion Criteria

Exclusion Criteria

* All patients must have a pathologically confirmed diagnosis of neuroblastoma, ≤ 30.99 years of age with history of relapsed/refractory neuroblastoma.
* All patients must have completed upfront therapy with at least 4 cycles of aggressive multi-drug chemotherapy.
* Specific Criteria by Arm:
* Timing from prior therapy: Enrollment (first dose of DFMO) no later than 60 days from last dose of the most recent therapy.
* Subjects must have fully recovered from the acute toxic effects of all prior anti- cancer chemotherapy and be within the following timelines:
1. Myelosuppressive chemotherapy: Must not have received within 2 weeks of enrollment onto this study (6 weeks if prior nitrosourea).
2. Hematopoietic growth factors: At least 5 days since the completion of therapy with a growth factor.
3. Biologic (anti-neoplastic agent): At least 7 days since the completion of therapy with a biologic agent. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the Study Chair.
4. Immunotherapy: At least 6 weeks since the completion of any type of immunotherapy, e.g. tumor vaccines, CAR-T cells.
5. Anti-GD2 Monoclonal antibodies: At least 2 weeks must have elapsed since prior treatment with a monoclonal antibody.
6. XRT: At least 14 days since the last treatment except for radiation delivered with palliative intent to a non-target site.
7. Stem Cell Transplant:
1. Allogeneic: No evidence of active graft vs. host disease
2. Allo/Auto: ≥ 2 months must have elapsed since transplant.
8. MIBG Therapy: At least 8 weeks since treatment with MIBG therapy
* Subjects must have a Lansky or Karnofsky Performance Scale score of 60% or higher.
* Life expectancy \> 2 months
* All clinical and laboratory studies for organ functions to determine eligibility must be performed within 7 days prior to first dose of study drug unless otherwise indicated below.
* Subjects must have adequate organ functions at the time of registration:
* Hematological: Total absolute neutrophil count ANC ≥750/μL
* Liver: Subjects must have adequate liver function as defined by AST and ALT \<5x upper limit of normal (Normal=45), Bilirubin \<1.5x upper limit normal (Normal=1.0). Normal PT, PTT, fibrinogen.
* Renal: Adequate renal function defined as (perform one of the following): Creatinine clearance or radioisotope GFR 70 mL/min/1.73 m2 or greater or a serum creatinine based on age/gender
* 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 guidelines must be obtained from all subjects (or patients' legal representative).

* BSA of \<0.25 m2.
* Subjects that received DFMO at a dose higher than 1000mg/m2 BID prior to this study are not eligible.
* Subjects that received a dose of DFMO in combination with etoposide are not eligible.
* 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.

Contacts and Locations

Study Contact

BCC Enroll

CONTACT

7175310003

BCCEnroll@pennstatehealth.psu.edu

Principal Investigator

Giselle Sholler, MD

STUDY_CHAIR

Beat Childhood Cancer

Study Locations (Sites)

University of Alabama, Children's Alabama

Birmingham, Alabama, 35201

United States

Arkansas Children's Hospital

Little Rock, Arkansas, 72202

United States

UCSF Benioff Children's Hospital Oakland-

Oakland, California, 94609

United States

Rady Children's Hospital

San Diego, California, 92123

United States

Connecticut Children's Hospital

Hartford, Connecticut, 06106

United States

Arnold Palmer Hospital for Children

Orlando, Florida, 32806

United States

St. Joseph's Children's Hospital

Tampa, Florida, 33614

United States

Augusta University Health

Augusta, Georgia, 30912

United States

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96813

United States

University of Louisville

Louisville, Kentucky, 40201

United States

Helen DeVos Children's Hospital

Grand Rapids, Michigan, 49503

United States

Children's Hospital and Clinics of Minnesota

Minneapolis, Minnesota, 55404

United States

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 64108

United States

Cardinal Glennon Children's Hospital

Saint Louis, Missouri, 63104

United States

Hackensack University Medical Center

Hackensack, New Jersey, 07601

United States

Levine Children's Hospital

Charlotte, North Carolina, 28204

United States

Cleveland Clinic Children's

Cleveland, Ohio, 44195

United States

Penn State Milton S. Hershey Medical Center and Children's Hospital

Hershey, Pennsylvania, 17033

United States

Hasbro Children's Hospital

Providence, Rhode Island, 02901

United States

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

Dell Children's Blood and Cancer Center

Austin, Texas, 78723

United States

Children's Medical Center Dallas

Dallas, Texas, 75235

United States

Children's Hospital of The King's Daughters

Norfolk, Virginia, 23507

United States

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: Giselle Sholler

Giselle Sholler, MD, STUDY_CHAIR, Beat Childhood Cancer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-09-25

Study Completion Date2033-10-01

Study Record Updates

Study Start Date2020-09-25

Study Completion Date2033-10-01

Terms related to this study

Additional Relevant MeSH Terms

Neuroblastoma