Aflac ST0901 CHOANOME - Sirolimus in Solid Tumors
Aflac ST0901
Sirolimus in Combination With Metronomic Therapy in Children With Recurrent and Refractory Solid Tumors: A Phase I Study
2 other identifiers
interventional
18
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Apr 2011
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 6, 2011
CompletedFirst Posted
Study publicly available on registry
April 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 9, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 9, 2017
CompletedMay 29, 2020
May 1, 2020
6.4 years
April 6, 2011
May 27, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum tolerated dose (MTD)
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.
2 years after treatment starts
Secondary Outcomes (4)
define and describe toxicities of sirolimus
2 years post treatment
anti-tumor activity of sirolimus
2 years post treatment
evaluate correlation of p70S6 kinase activity
2 years post treatment
evaluate risk of infection
2 years post treatment
Study Arms (1)
sirolimus treatment
EXPERIMENTALDose escalation of sirolimus with starting dose at 1 mg/m2 and increasing to a possible 3 mg/m2.
Interventions
daily administration of sirolimus in oral form starting at a dose of 1 mg/m2 and increasing to a possible 3 mg/m2.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
- Children's Healthcare of Atlantacollaborator
Study Sites (1)
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322, United States
Related Publications (1)
Qayed 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: 31876107RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Muna Qayed, MD
Children's Healthcare of Atlanta
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 6, 2011
First Posted
April 7, 2011
Study Start
April 1, 2011
Primary Completion
August 9, 2017
Study Completion
August 9, 2017
Last Updated
May 29, 2020
Record last verified: 2020-05