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

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.

Conditions

Solid Tumor

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Solid Tumor
Intervention / Treatment

-

Contacts and Locations

Long Beach

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

Orange

Children's Hospital Orange County, Orange, California, United States, 92868

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. The following solid tumors will be studied: rhabdomyosarcoma, osteosarcoma, Ewing sarcoma, other soft tissue sarcomas
  • 2. Other solid tumors fulfilling the remainder of eligibility criteria and available historical data to determine time to tumor progression
  • 3. Expected time to progression of \< 2 years, based on historical data
  • 4. All patients will have completed front-line therapy
  • 5. All patients will be in remission from their primary diagnosis
  • 6. All patients will start metronomic therapy within 6 weeks of completion of front-line treatment
  • 7. All patient will have recovered from previous toxicities
  • 8. All patients or their parents/legal guardian will have signed an informed consent document
  • 9. All institutional eligibility criteria will be meet
  • 10. Age: Patients must be ≥ 12 months and \<31 years of age at the time of study entry
  • 11. Patients must have had histologic verification of malignancy at original diagnosis
  • 12. Patients must have a Lansky or Karnofsky performance status score of ≥ 50, corresponding to ECOG categories 0, 1 or 2.
  • 13. Adequate renal function defined as: Normal serum creatinine
  • 14. Normal liver tests (ALT/AST/total bilirubin/triglycerides/cholesterol)
  • 15. Recovered from all surgical procedures for at least 7 days (minor procedures) or 28 days (major procedures)
  • 16. Adequate cardiac function defined as: Shortening fraction of ≥ 27% by echocardiogram, or ejection fraction of ≥ 50% by radionuclide angiogram
  • 17. Platelet count 100,000K/uL (transfusion independent), hemoglobin 8.0 g/dL
  • 18. Adequate bone marrow function: Peripheral absolute neutrophil count (ANC) 1,000K/uL
  • 19. Signed Informed Consent document and/or Assent document
  • 1. Female patients who are pregnant
  • 2. Lactating females are not eligible unless they have agreed to discontinue breastfeeding
  • 3. Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
  • 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. Any primary central nervous system tumor
  • 6. Any patient who has experienced relapsed or refractory disease or a second malignancy.
  • 7. Any patient not in remission

Ages Eligible for Study

12 Months to 31 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

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

2029-07