Actively Recruiting
Metronomic Therapy for Pediatric Patients With Solid Tumors at High Risk of Recurrence
Led by Miller Children's & Women's Hospital Long Beach · Updated on 2015-05-18
20
Participants Needed
2
Research Sites
782 weeks
Total Duration
On this page
Sponsors
M
Miller Children's & Women's Hospital Long Beach
Lead Sponsor
C
Children's Hospital of Orange County
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Metronomic Therapy for Pediatric Patients With Solid Tumors at High Risk of Recurrence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with rhabdomyosarcoma, osteosarcoma, Ewing sarcoma, or other soft tissue sarcomas
- Other solid tumors with available historical data to assess time to tumor progression
- Expected time to progression less than 2 years based on historical data
- Completed front-line therapy
- Currently in remission from primary diagnosis
- Able to start metronomic therapy within 6 weeks of completing front-line treatment
- Recovered from previous treatment toxicities
- Signed informed consent by patient or legal guardian
- Meet all institutional eligibility requirements
- Age between 12 months and less than 31 years at study entry
- Histologic confirmation of malignancy at original diagnosis
- Lansky or Karnofsky performance status score of 50 or higher
- Adequate renal function with normal serum creatinine
- Normal liver function tests including ALT, AST, total bilirubin, triglycerides, and cholesterol
- Recovered from surgical procedures for at least 7 days (minor) or 28 days (major)
- Adequate cardiac function with shortening fraction ≥ 27% or ejection fraction ≥ 50%
- Platelet count at least 100,000K/uL (transfusion independent) and hemoglobin at least 8.0 g/dL
- Adequate bone marrow function with absolute neutrophil count (ANC) ≥ 1,000K/uL
- Signed informed consent and/or assent documents
You will not qualify if you...
- Female patients who are pregnant
- Lactating females unless they agree to stop breastfeeding
- Female patients of childbearing potential without a negative pregnancy test
- Sexually active patients of reproductive potential who do not agree to use effective contraception during the study
- Any primary central nervous system tumor
- Patients with relapsed or refractory disease or a second malignancy
- Patients not currently in remission
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Miller Children's and Women's Hospital Long Beach
Long Beach, California, United States, 90806
Actively Recruiting
2
Children's Hospital Orange County
Orange, California, United States, 92868
Actively Recruiting
Research Team
T
Ted Zwerdling, MD
CONTACT
D
Devin Murphy, MSW
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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