NCT02446431RecruitingEarly phase 1
Metronomic Therapy for Pediatric Patients With Solid Tumors at High Risk of Recurrence
Metronomic Therapy for Pediatric Patients With Solid Tumors at High Risk of Recurrence: A Multi-Institutional Study
Source: ClinicalTrials.gov · Last updated 18 May 2015 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 28 Apr 2015
- Start date
- Jul 2014
- Primary completion date
- Jul 2024
- Lead sponsor
- Miller Children's & Women's Hospital Long Beach
- Diseases
- Childhood cancers
- NCT number
- NCT02446431
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 20
- From Jul 2014 to the primary completion date, Jul 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any patient who has experienced relapsed or refractory disease or a second malignancy.
Other
- Female patients who are pregnant
- Lactating females are not eligible unless they have agreed to discontinue breastfeeding
- Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
- 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
- Any primary central nervous system tumor
- Any patient not in remission
Who the study is looking for
- The following solid tumors will be studied: rhabdomyosarcoma, osteosarcoma, Ewing sarcoma, other soft tissue sarcomas
- Other solid tumors fulfilling the remainder of eligibility criteria and available historical data to determine time to tumor progression
- Expected time to progression of \< 2 years, based on historical data
- All patients will have completed front-line therapy
- All patients will be in remission from their primary diagnosis
- All patients will start metronomic therapy within 6 weeks of completion of front-line treatment
- All patient will have recovered from previous toxicities
- All patients or their parents/legal guardian will have signed an informed consent document
- All institutional eligibility criteria will be meet
- Age: Patients must be ≥ 12 months and \<31 years of age at the time of study entry
- Patients must have had histologic verification of malignancy at original diagnosis
- Patients must have a Lansky or Karnofsky performance status score of ≥ 50, corresponding to ECOG categories 0, 1 or 2.
- Adequate renal function defined as: Normal serum creatinine
- Normal liver tests (ALT/AST/total bilirubin/triglycerides/cholesterol)
- Recovered from all surgical procedures for at least 7 days (minor procedures) or 28 days (major procedures)
- Adequate cardiac function defined as: Shortening fraction of ≥ 27% by echocardiogram, or ejection fraction of ≥ 50% by radionuclide angiogram
- Platelet count 100,000K/uL (transfusion independent), hemoglobin 8.0 g/dL
- Adequate bone marrow function: Peripheral absolute neutrophil count (ANC) 1,000K/uL
- Signed Informed Consent document and/or Assent document
Age in the registry: 12 months to 31 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Miller Children's and Women's Hospital Long Beach Coordinator of this site? Confirm its status | Long Beach | United States | Recruiting |
| Children's Hospital Orange County Coordinator of this site? Confirm its status | Orange | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.