RECRUITING

Metronomic Therapy for Pediatric Patients With Solid Tumors at High Risk of Recurrence

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Solid TumorMetronomic Drug Therapy

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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

Most pediatric patients with solid tumors respond to initial high-dose, intensive therapy and complete treatment in remission. High-risk patients however, frequently have recurrent disease which is then treated with ad hoc regimens or early phase therapies with little benefit to the patient. Metronomic therapy (MC), defined as lower dose continuous drug exposure, has been successfully tested in pediatric leukemias with excellent results in terms of improved outcome, toxicity profiles, and cost. MC has been applied to solid tumors with little success, but has been implemented usually in the relapsed setting at a time of high tumor burden and disease resistance.

Official Title

Metronomic Therapy for Pediatric Patients With Solid Tumors at High Risk of Recurrence: A Multi-Institutional Study

Quick Facts

Study Start:2014-07
Study Completion:2029-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02446431

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:12 Months to 31 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. The following solid tumors will be studied: rhabdomyosarcoma, osteosarcoma, Ewing sarcoma, other soft tissue sarcomas
  2. 2. Other solid tumors fulfilling the remainder of eligibility criteria and available historical data to determine time to tumor progression
  3. 3. Expected time to progression of \< 2 years, based on historical data
  4. 4. All patients will have completed front-line therapy
  5. 5. All patients will be in remission from their primary diagnosis
  6. 6. All patients will start metronomic therapy within 6 weeks of completion of front-line treatment
  7. 7. All patient will have recovered from previous toxicities
  8. 8. All patients or their parents/legal guardian will have signed an informed consent document
  9. 9. All institutional eligibility criteria will be meet
  10. 10. Age: Patients must be ≥ 12 months and \<31 years of age at the time of study entry
  11. 11. Patients must have had histologic verification of malignancy at original diagnosis
  12. 12. Patients must have a Lansky or Karnofsky performance status score of ≥ 50, corresponding to ECOG categories 0, 1 or 2.
  13. 13. Adequate renal function defined as: Normal serum creatinine
  14. 14. Normal liver tests (ALT/AST/total bilirubin/triglycerides/cholesterol)
  15. 15. Recovered from all surgical procedures for at least 7 days (minor procedures) or 28 days (major procedures)
  16. 16. Adequate cardiac function defined as: Shortening fraction of ≥ 27% by echocardiogram, or ejection fraction of ≥ 50% by radionuclide angiogram
  17. 17. Platelet count 100,000K/uL (transfusion independent), hemoglobin 8.0 g/dL
  18. 18. Adequate bone marrow function: Peripheral absolute neutrophil count (ANC) 1,000K/uL
  19. 19. Signed Informed Consent document and/or Assent document
  1. 1. Female patients who are pregnant
  2. 2. Lactating females are not eligible unless they have agreed to discontinue breastfeeding
  3. 3. Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
  4. 4. Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of study participation
  5. 5. Any primary central nervous system tumor
  6. 6. Any patient who has experienced relapsed or refractory disease or a second malignancy.
  7. 7. Any patient not in remission

Contacts and Locations

Study Contact

Ted Zwerdling, MD
CONTACT
562-933-8600
tzwerdling@memorialcare.org
Devin Murphy, MSW
CONTACT
562-933-8601
dmurphy@memorialcare.org

Principal Investigator

Ted Zwerdling, MD
PRINCIPAL_INVESTIGATOR
Miller Children's and Women's Hospital Long Beach

Study Locations (Sites)

Miller Children's and Women's Hospital Long Beach
Long Beach, California, 90806
United States
Children's Hospital Orange County
Orange, California, 92868
United States

Collaborators and Investigators

Sponsor: Miller Children's & Women's Hospital Long Beach

  • Ted Zwerdling, MD, PRINCIPAL_INVESTIGATOR, Miller Children's and Women's Hospital Long Beach

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 Date2014-07
Study Completion Date2029-07

Study Record Updates

Study Start Date2014-07
Study Completion Date2029-07

Terms related to this study

Keywords Provided by Researchers

  • Metronomic Drug Therapy

Additional Relevant MeSH Terms

  • Solid Tumor