Solid TumorPhase 2AflacST1903NCT04469530
Sirolimus in Combination With Metronomic Chemotherapy in Children With High-Risk Solid Tumors
A Phase 2 study testing Sirolimus, Cyclophosphamide and Etoposide in people with Solid Tumor, run by Emory University at 5 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 1 year to 30 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Sirolimus, Cyclophosphamide and Etoposide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 5 sitesUnited States
- Study dates
- 16 Sep 2020to Feb 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subjects must be ≥ 12 months and ≤ 30 years of age at the time of study enrollment.
- Subjects 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 administered with curative intent (cohort 1) or after completion of initial relapse regimen.
- 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 rhabdoid tumor.
- 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.
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- Prospective Cohort 2: Recurrent extracranial solid tumor (any histology) in second complete remission following completion of initial relapse regimen.
- Subjects must have had histologic verification of malignancy at original diagnosis or relapse.
- Subjects 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 completion of initial relapse regimen (cohort 2).
- Karnofsky ≥ 50% for subjects > 16 years of age and Lansky ≥ 50% for subjects ≤ 16 years of age.
- Subjects 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 (ie peripheral neuropathy) must be improved to at least grade 2 and be stable or improving on current management.
- 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 enrollment).
- 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 GFR utilizing child length and stature data published by the Centers for Disease Control and Prevention (CDC).
- 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 subjects who do not have respiratory symptoms (no dyspnea at rest, O2 sat ≥ 93% on room air), PFTs are not required.
Who cannot join
- 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 reproductive potential may not participate unless they have agreed to use an effective contraceptive method during treatment and for 3 months after stopping treatment.
- Concomitant Medication
- Subjects receiving corticosteroids must be on a stable or decreasing dose of corticosteroid for the prior 7 days.
- Subjects who are currently receiving enzyme inducing anticonvulsants are not eligible.
- Subjects must not be receiving potent CYP3A4 inducers or inhibitors.
- Subjects who are currently receiving another investigational drug are not eligible.
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- Subjects who are currently receiving any other anti-cancer agents are not eligible.
- Subjects who have an uncontrolled infection are not eligible.
- Subjects enrolled on a clinical trial for upfront therapy or relapse therapy for those patients in second complete remission.
- Subjects who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Aflac Cancer & Blood Disorders Centers
Atlanta, Georgia, 30329
Kathryn Sutton, MD, 4047851651, Kathryn.Sutton@choa.org
- Recruiting
Children's Healthcare of Atlanta
Atlanta, Georgia, 30329
Kathryn Sutton, MD, 404-785-1651, Kathryn.Sutton@choa.org
- Recruiting
Texas Children's Cancer Center
Houston, Texas, 77030
Sarah Kappa, MD, (832) 824-4724, sskappa@texaschildrens.org
- Recruiting
Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, 15224
Andrew Bukowinski, MD, MS, (412) 692-8864, Andrew.bukowinski2@chp.edu
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Amy Armstrong, MD, (314) 454-6018, armstrongae@wustl.edu
About this study
Official title: A Maintenance Protocol of Sirolimus in Combination With Metronomic Chemotherapy in Children With High-Risk Solid Tumors
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.
Read the detailed description
Sirolimus, also known as rapamycin, is a potent immunosuppressive drug. Due to its profound immunosuppressive actions, sirolimus was initially developed and received regulatory approval for the indication of prevention of allograft rejection following solid organ transplant. Sirolimus also possesses anti-tumor activity through its anti-proliferative effect, by the inhibition of translation of key messenger ribonucleic acids (mRNAs) into proteins required for cell cycle progression from the G1 to the S phase.
Palliative care with the use of antiangiogenic metronomic chemotherapy in the form of low-dose daily oral administration of etoposide and cyclophosphamide in combination with antiangiogenic agents such as celecoxib, is feasible and well-tolerated in children with refractory solid tumors
Sirolimus is used orally in adults and children for the prevention of allograft rejection following solid organ transplant. The Pediatric Preclinical Testing Program (PPTP) performed testing of sirolimus as a single agent against an in vitro panel of pediatric cell lines, as well as against in vivo pediatric tumor panels. Sirolimus exhibited variable inhibition of cell line growth, ranging from 19% to 85% (median 49%).
This study has three cohorts: a prospective cohort of patients with high-risk extracranial solid tumor, a prospective cohort of patients with recurrent solid tumors (any histology) in second complete remission, and a historical control cohort of patients matched 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. The primary objective of the 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.
- Conditions
- Solid Tumor
- Being tested
- Sirolimus, Cyclophosphamide, Etoposide, Celecoxib
- Keywords
- Pediatrics, Chemotherapy, Remission, Survival
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SirolimusDrug
Also called Rapamune, rapamycin
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.
CyclophosphamideDrug
Also called Cytoxan
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.
EtoposideDrug
Also called VP-16, VePesid, Toposar, Etopophos
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.
CelecoxibDrug
Also called Celebrex
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 group | Role | What they receive |
|---|---|---|
| Maintenance Chemotherapy Regimen | Experimental | 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. Receives: Drug: Sirolimus; Drug: Cyclophosphamide; Drug: Etoposide; Drug: Celecoxib |
| Historical Control Cohort Receiving Standard Therapy | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Two-year progression-free survival in patients with high-risk solid tumors
Two-year progression-free survival in patients with high-risk solid tumors who complete a 12- month course of maintenance chemotherapy with daily sirolimus and twice daily celecoxib on a backbone of low-dose oral metronomic chemotherapy following completion of "standard" therapy as compared to a historical cohort of matched patients treated with observation only following completion of "standard" therapy.
Measured: up to 2 years
Secondary outcomes (6)
Median progression-free survival of children with high-risk solid tumors
Median progression-free survival in patients with high-risk solid tumors who complete a 12- month course of maintenance chemotherapy with daily sirolimus and twice daily celecoxib on a backbone of low-dose oral metronomic chemotherapy following completion of "standard" therapy as compared to a historical cohort of matched patients treated with observation only following completion of "standard" therapy.
Measured: up to 2 years
Two-year progression-free survival for all prospectively enrolled participants
Two-year progression-free survival for all prospectively enrolled participants (those in cohorts 1 and 2).
Measured: up to 2 years
Two-year overall survival for all prospectively enrolled participants
Two-year overall survival for all prospectively enrolled participants (those in cohorts 1 and 2).
Measured: up to 2 years
Number of cases of severe toxicities
The incidence of severe toxicities, defined as toxicities requiring dose modifications, of daily sirolimus and twice daily celecoxib administered on a backbone of low-dose metronomic chemotherapy for 12 months as maintenance therapy following completion of "standard" therapy.
Measured: up to 2 years
Number of patients who come off protocol therapy due to toxicity or non-compliance
Feasibility of completion of a 12-month course of maintenance chemotherapy following completion of "standard" therapy will be evaluated by number of patients who come off protocol therapy due to toxicity or non-compliance.
Measured: up to 2 years
Median progression-free survival of children with recurrent solid tumors in second complete remission
The median progression-free survival of children with recurrent solid tumors in second complete remission following completion of an initial relapse treatment regimen will be evaluated
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start16 Sep 2020
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- PeachBowl LegACy Fund
- Responsible party
- Principal investigator, Kathryn S. Sutton, Emory University
- Investigators
- Kathryn Sutton, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04469530
- Sponsor's protocol ID
- STUDY00000113
- Acronym
- AflacST1903
- Status last verified
- Feb 2026
- First submitted
- 6 Jul 2020
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available for sharing in the future after data analysis for this study is complete. Data will be available for sharing if requested or it is felt it would be of value to a particular research community.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Maintenance Protocol of Sirolimus in Combination With Metronomic Chemotherapy in Children With High-Risk Solid Tumors
- ClinicalTrials.gov ID
- NCT04469530
- Acronym / sponsor ID
- AflacST1903 / STUDY00000113
- Conditions
- Solid Tumor
- Keywords
- Pediatrics, Chemotherapy, Remission, Survival
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- PeachBowl LegACy Fund
- Study start
- 16 Sep 2020 (actual)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 14 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Sirolimus, also known as rapamycin, is a potent immunosuppressive drug. Due to its profound immunosuppressive actions, sirolimus was initially developed and received regulatory approval for the indication of prevention of allograft rejection following solid organ transplant. Sirolimus also possesses anti-tumor activity through its anti-proliferative effect, by the inhibition of translation of key messenger ribonucleic acids (mRNAs) into proteins required for cell cycle progression from the G1 to the S phase.
Palliative care with the use of antiangiogenic metronomic chemotherapy in the form of low-dose daily oral administration of etoposide and cyclophosphamide in combination with antiangiogenic agents such as celecoxib, is feasible and well-tolerated in children with refractory solid tumors
Sirolimus is used orally in adults and children for the prevention of allograft rejection following solid organ transplant. The Pediatric Preclinical Testing Program (PPTP) performed testing of sirolimus as a single agent against an in vitro panel of pediatric cell lines, as well as against in vivo pediatric tumor panels. Sirolimus exhibited variable inhibition of cell line growth, ranging from 19% to 85% (median 49%).
This study has three cohorts: a prospective cohort of patients with high-risk extracranial solid tumor, a prospective cohort of patients with recurrent solid tumors (any histology) in second complete remission, and a historical control cohort of patients matched 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. The primary objective of the 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maintenance Chemotherapy Regimen | Experimental | Drug: Sirolimus, Drug: Cyclophosphamide, Drug: Etoposide, Drug: CelecoxibParticipants 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. |
| Historical Control Cohort Receiving Standard Therapy | No intervention | –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. |
Who may qualify
- Ages
- 1 year to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (17 listed)
- Subjects must be ≥ 12 months and ≤ 30 years of age at the time of study enrollment.
- Subjects 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 administered with curative intent (cohort 1) or after completion of initial relapse regimen.
- Subjects must have had histologic verification of malignancy at original diagnosis or relapse.
- Subjects 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 completion of initial relapse regimen (cohort 2).
- Karnofsky ≥ 50% for subjects > 16 years of age and Lansky ≥ 50% for subjects ≤ 16 years of age.
Key exclusion criteria (10 listed)
- 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 reproductive potential may not participate unless they have agreed to use an effective contraceptive method during treatment and for 3 months after stopping treatment.
- Concomitant Medication
- Subjects who have an uncontrolled infection are not eligible.
- Subjects enrolled on a clinical trial for upfront therapy or relapse therapy for those patients in second complete remission.
- Subjects who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SirolimusAlso: Rapamune, rapamycinSirolimus 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. | Drug | Maintenance Chemotherapy Regimen |
| CyclophosphamideAlso: CytoxanA 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. | Drug | Maintenance Chemotherapy Regimen |
| EtoposideAlso: VP-16, VePesid, Toposar, EtopophosA 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. | Drug | Maintenance Chemotherapy Regimen |
| CelecoxibAlso: CelebrexThe drug is administered orally daily, in the formulation appropriate for age.The solution is safe for administration through a nasogastric or G-tube. | Drug | Maintenance Chemotherapy Regimen |
Primary outcome
Two-year progression-free survival in patients with high-risk solid tumors
Time frame: up to 2 years
Two-year progression-free survival in patients with high-risk solid tumors who complete a 12- month course of maintenance chemotherapy with daily sirolimus and twice daily celecoxib on a backbone of low-dose oral metronomic chemotherapy following completion of "standard" therapy as compared to a historical cohort of matched patients treated with observation only following completion of "standard" therapy.
6 secondary outcomes
Median progression-free survival of children with high-risk solid tumors
Time frame: up to 2 years
Two-year progression-free survival for all prospectively enrolled participants
Time frame: up to 2 years
Two-year overall survival for all prospectively enrolled participants
Time frame: up to 2 years
Number of cases of severe toxicities
Time frame: up to 2 years
Number of patients who come off protocol therapy due to toxicity or non-compliance
Time frame: up to 2 years
Median progression-free survival of children with recurrent solid tumors in second complete remission
Time frame: up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Yes. Data will be available for sharing in the future after data analysis for this study is complete. Data will be available for sharing if requested or it is felt it would be of value to a particular research community.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kathryn Sutton, MD principal investigator
Emory University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sirolimus, Cyclophosphamide and Etoposide in people with Solid Tumor, run by Emory University at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kathryn Sutton, MD (404-785-1651, Kathryn.Sutton@choa.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Two-year progression-free survival in patients with high-risk solid tumors (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.