Clinical trial · Interventional
Aflac ST0901 CHOANOME - Sirolimus in Solid Tumors
Sirolimus in Combination With Metronomic Therapy in Children With Recurrent and Refractory Solid Tumors: A Phase I Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The best treatment for recurrent cancers or those that do not respond to therapies is not known. Typically, patients with these cancers receive a combination of cancer drugs (chemotherapy), surgery, or radiation therapy. These treatments can prolong their life but may not offer a long-term cure. This study proposes using a drug called Sirolimus in combination with common chemotherapy drugs to treat patients with recurrent and refractory solid tumors. Sirolimus has been found to inhibit cell growth and to have anti-tumor activity in pediatric solid tumors in previous studies and, therefore, has the potential to increase the effectiveness of the chemotherapy drugs when given together. This study wil investigate the highest dose of Sirolimus that can be given orally with other oral chemotherapy drugs. Cohorts of 2 subjects will be started at the minimum dose. The dose will be increased in the next 2 subjects as long as there were no major reactions in the previous groups. This study will also seek to learn more about the side effects of sirolimus when used in this combination and what effects the drug has on the white cells and the immune system. Successful use of this drug will impact the cancer population greatly by providing an increased chance of survival to those with resistant or recurrent cancers.
Conditions
Conditions (16)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Astrocytoma | Astrocytoma | CURATED_BROADER | 0.80 |
| Atypical Teratoid/Rhabdoid Tumor | Atypical Teratoid/Rhabdoid Tumor | ONTOLOGY_EXACT | 0.90 |
| Clear Cell Sarcoma | Clear Cell Sarcoma of Soft Tissue | ALIAS | 0.90 |
| Ependymoma | Ependymoma | ONTOLOGY_EXACT | 0.90 |
| Ewing's Sarcoma | Ewing Sarcoma | ALIAS | 0.90 |
| Germ Cell Tumor | Germ Cell Tumor | ONTOLOGY_EXACT | 0.90 |
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
| Hepatoblastoma | Hepatoblastoma | ONTOLOGY_EXACT |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| sirolimus | Drug | Sirolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- sirolimus treatment
- description
- Dose escalation of sirolimus with starting dose at 1 mg/m2 and increasing to a possible 3 mg/m2.
- interventionNames
- Drug: sirolimus
Primary outcomes (1)
- measure
- Maximum tolerated dose (MTD)
- timeFrame
- 2 years after treatment starts
- description
- estimate the maximum tolerated dose (MTD) and recommended Phase II dose of sirolimus administered orally once daily for 42 days in combination with metronomic chemotherapy in children with recurrent or refractory solid tumors.
Secondary outcomes (4)
- measure
- define and describe toxicities of sirolimus
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: * must be \<=30 years of age at time of study enrollment * histologic verification of malignancy at original diagnosis or relapsis except in patients with intrinsic brain stem tumors, optic pathway gliomas or patients wtih pineal tumors and evaluations of serum or CSF alpha-fetoprotein or beta-HCG * measurable or evaluable disease * disease state must be one for which there is no known curative therapy * Performance level \>=50% * Patients must have fully recovered from acute toxic effects of all prior chemotherapy, immunotherapy or radiotherapy * no evidence of acute graft vs. host disease and \>=3 months since transplant * organ function as defined in eligibility section of protocol Exclusion Criteria: * patients cannot be pregnant or breast-feeding * patients must agree to use of an effective contraceptive method * no growth factors that support platelet or white cell number or function for at least 7 days prior to enrollment * patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for the prior 7 days are not eligible * patients receiving any other investigational drugs * patients receiving any other anti-cancer drugs * patients who have an uncontrolled infection
References
Publications (1)
- RESULTQayed M, Cash T, Tighiouart M, MacDonald TJ, Goldsmith KC, Tanos R, Kean L, Watkins B, Suessmuth Y, Wetmore C, Katzenstein HM. A phase I study of sirolimus in combination with metronomic therapy (CHOAnome) in children with recurrent or refractory solid and brain tumors. Pediatr Blood Cancer. 2020 Apr;67(4):e28134. doi: 10.1002/pbc.28134. Epub 2019 Dec 25. PMID 31876107