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New treatment option for Solid Tumor
Official title Sirolimus in Combination With Metronomic Chemotherapy in Children With High-Risk Solid Tumors
ClinicalTrials.gov ID: NCT04469530
What this study is testing
What is Sirolimus?
Sirolimus is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for solid tumor.
Also referred to as Rapamune, rapamycin.
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
- The primary objective of this study is to improve the 2-year progression-free survival in children with high-risk solid tumors who are administered a maintenance regimen with continuous sirolimus administered on a backbone of metronomic chemotherapy following the completion of "standard" therapy, as compared to high-risk solid tumor patients treated with observation alone following completion of "standard" therapy.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 30
You may be able to join if
- people must be ≥ 12 months and ≤ 30 years of age at the time of study enrollment.
- people must have one of the following high-risk malignant pediatric extracranial solid tumors and be in complete remission or have minimal...
- Prospective Cohort 1:
- Metastatic/unresectable osteosarcoma, metastatic Ewing or Ewing-like sarcoma, high-risk rhabdomyosarcoma, metastatic non-rhabdomyosarcoma soft tissue...
- Additional high-risk solid tumors at the request of the treating physician after approval by the study chair.
You likely can't join if
- Pregnant or breast-feeding women will not be entered on this study as there may be fetal risks or teratogenic toxicities. Pregnancy tests must be...
- Concomitant Medication
- people receiving corticosteroids must be on a stable or decreasing dose of corticosteroid for the prior 7 days.
- people who are currently receiving enzyme inducing anticonvulsants are not eligible.
- people must not be receiving potent CYP3A4 inducers or inhibitors.
- people who are currently receiving another investigational drug are not eligible.
See the full eligibility criteria
- people must be ≥ 12 months and ≤ 30 years of age at the time of study enrollment.
- people must have one of the following high-risk malignant pediatric extracranial solid tumors and be in complete remission or have minimal abnormalities on imaging studies after completion of upfront therapy...
- Prospective Cohort 1:
- Metastatic/unresectable osteosarcoma, metastatic Ewing or Ewing-like sarcoma, high-risk rhabdomyosarcoma, metastatic non-rhabdomyosarcoma soft tissue sarcoma, desmoplastic small round cell tumor (DSRCT), malignant...
- Additional high-risk solid tumors at the request of the treating physician after approval by the study chair.
- Primary central nervous system (CNS) tumors and lymphomas are not eligible.
- Prospective Cohort 2: Recurrent extracranial solid tumor (any histology) in second complete remission following completion of initial relapse regimen.
- people must have had histologic verification of malignancy at original diagnosis or relapse.
- people must be in complete remission or with minimal radiological abnormalities. Baseline imaging should be the end of therapy imaging obtained at the completion of "standard" upfront therapy (cohort 1) or at the...
- Karnofsky ≥ 50% for people \> 16 years of age and Lansky ≥ 50% for people ≤ 16 years of age.
- people must have fully recovered from the acute non-hematologic toxic effects of all prior anti-cancer therapy and meet hematologic count parameters. Chronic non-hematologic toxic effects of prior anti-cancer therapy...
- Adequate bone marrow function defined as absolute neutrophil count (ANC) ≥ 750/μL and platelet count ≥ 50,000/μL (transfusion independent, defined as not receiving platelet transfusions within 7 days prior to...
- Adequate renal function defined as creatinine clearance or radioisotope glomerular filtration rate (GFR) 70ml/min/1.73 m2 or serum creatinine based on age/gender values derived from the Schwartz formula for estimating...
- Adequate liver function defined as: total bilirubin ≤ 2x upper limit of normal (ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 225 U/L (5x the ULN).
- Serum triglyceride level ≤300 mg/dL and serum cholesterol ≤ 300 mg/dL.
- Random blood glucose ≤ 1.5x ULN for age.
- Adequate pulmonary function defined as normal pulmonary function tests (PFTs), if there is a clinical indication for determination (dyspnea at rest, known requirement for supplemental oxygen). For people who do not have...
- Pregnant or breast-feeding women will not be entered on this study as there may be fetal risks or teratogenic toxicities. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of...
- Concomitant Medication
- people receiving corticosteroids must be on a stable or decreasing dose of corticosteroid for the prior 7 days.
- people who are currently receiving enzyme inducing anticonvulsants are not eligible.
- people must not be receiving potent CYP3A4 inducers or inhibitors.
- people who are currently receiving another investigational drug are not eligible.
- people who are currently receiving any other anti-cancer agents are not eligible.
- people who have an uncontrolled infection are not eligible.
- people enrolled on a clinical trial for upfront therapy or relapse therapy for those patients in second complete remission.
- people who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible.
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
- St Louis, Missouri, United States
- Pittsburgh, Pennsylvania, United States
- Houston, Texas, 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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 30 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States; St Louis, Missouri, United States; Pittsburgh, Pennsylvania, United States; Houston, Texas, 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.