Sirolimus in Combination With Metronomic Chemotherapy in Children With High-Risk Solid Tumors

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT04469530
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
1 Year - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • Sirolimus — DRUG
    Sirolimus is given at a dose of 2 mg/m2 once daily. The amber oral dose syringe should be used to withdraw the prescribed amount of sirolimus oral solution from the bottle. The solution can be drunk or administered at once to assure delivery of all of the medication. It is safe for administration through a nasogastric or G-tube. For tablets, the tablet should not be crushed, split, or otherwise altered. As with the liquid dosing form, the tablets should be given within two hours each day and should be at consistent intervals with regard to meals.
  • Cyclophosphamide — DRUG
    A synthetic antineoplastic drug chemically related to the nitrogen mustards. The drug is administered orally daily, in the formulation appropriate for age. The solution should be diluted in 20-30 ml of appropriate liquid before administration through nasogastric (NG) tube or gastrostomy (G) tube, with adequate flushing after administration to prevent obstruction of the feeding tube.
  • Etoposide — DRUG
    A semisynthetic derivative of podophyllotoxin which functions as mitotic inhibitor but does not interfere with microtubular assembly. The drug is administered orally daily, in the formulation appropriate for age.
  • Celecoxib — DRUG
    The drug is administered orally daily, in the formulation appropriate for age.The solution is safe for administration through a nasogastric or G-tube.

Study Details

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.

Key Dates

Start date
Sep 16, 2020
Status verified
Feb 2026
Primary completion
Feb 28, 2029
Completion
Feb 28, 2029

Study Design

Enrollment
55 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Maintenance Chemotherapy Regimen
    Participants with metastatic osteosarcoma, metastatic Ewing sarcoma, high-risk rhabdomyosarcoma, metastatic non-rhabdomyosarcoma soft tissue sarcoma (NRSTS), desmoplastic small round cell tumor (DSRCT), and malignant rhabdoid tumor (MRT) in first complete remission (cohort 1) or participants with recurrent solid tumors (any histology) in second complete remission (cohort 2), receiving a maintenance chemotherapy regimen administered as a 12-month course of continuous sirolimus with celecoxib and low-dose oral etoposide alternating every 21 days with low-dose oral cyclophosphamide following the completion of "standard" therapy.
  • No Intervention: Historical Control Cohort Receiving Standard Therapy
    This study arm is a historical control cohort of patients matched with cohort 1 on diagnosis, age, metastatic site, and date of diagnosis. The matched historical controls will be obtained from the same treating institution as the corresponding case to account for institutional differences in treatment and supportive care. Patients in the historical control cohort received standard therapy.

Primary Outcome Measure

Two-year progression-free survival in patients with high-risk solid tumors [ Time Frame: up to 2 years ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Aflac Cancer & Blood Disorders CentersAtlantaGeorgia30329
Kathryn Sutton, MD
[email protected]
4047851651
Children's Healthcare of AtlantaAtlantaGeorgia30329
Kathryn Sutton, MD
[email protected]
404-785-1651
Washington University School of MedicineSt LouisMissouri63110
Amy Armstrong, MD
[email protected]
(314) 454-6018
Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center (UPMC)PittsburghPennsylvania15224
Andrew Bukowinski, MD, MS
[email protected]
(412) 692-8864
Texas Children's Cancer CenterHoustonTexas77030
Sarah Kappa, MD
[email protected]
(832) 824-4724

Find similar trials in Atlanta, GA

By research site
Aflac Cancer & Blood Disorders Centers· Atlanta, GAChildren's Healthcare of Atlanta· Atlanta, GAWashington University School of Medicine· St Louis, MOChildren's Hospital of Pittsburgh of University of Pittsburgh Medical Center (UPMC)· Pittsburgh, PATexas Children's Cancer Center· Houston, TX

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