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New treatment option for Solid Tumor
Official title Metronomic Therapy for Pediatric Patients With Solid Tumors at High Risk of Recurrence
ClinicalTrials.gov ID: NCT02446431
What this study is testing
What is Bevacizumab?
Bevacizumab is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for solid tumor.
Also referred to as Avastin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 10 years
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 31
You may be able to join if
- 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
You likely can't join if
- 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...
- Any primary central nervous system tumor
- Any patient who has experienced relapsed or refractory disease or a second malignancy.
See the full eligibility criteria
- 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
- 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 who has experienced relapsed or refractory disease or a second malignancy.
- Any patient not in remission
The study team makes the final eligibility decision.
Where it's taking place
- Long Beach, California, United States
- Orange, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 10 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 12 months to 31 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Long Beach, California, United States; Orange, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.