- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01331135
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30322
- Children's Healthcare of Atlanta
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: sirolimus treatment
Dose escalation of sirolimus with starting dose at 1 mg/m2 and increasing to a possible 3 mg/m2.
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daily administration of sirolimus in oral form starting at a dose of 1 mg/m2 and increasing to a possible 3 mg/m2.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum tolerated dose (MTD)
Time Frame: 2 years after treatment starts
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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.
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2 years after treatment starts
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
define and describe toxicities of sirolimus
Time Frame: 2 years post treatment
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To define and describe the toxicities of sirolimus administered in combination with metronomic chemotherapy administered according to this schedule.
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2 years post treatment
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anti-tumor activity of sirolimus
Time Frame: 2 years post treatment
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To assess the antitumor activity of sirolimus administered in combination with metronomic chemotherapy to children with recurrent and refractory solid tumors within the confines of a Phase I study.
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2 years post treatment
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evaluate correlation of p70S6 kinase activity
Time Frame: 2 years post treatment
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To evaluate the correlation of p70S6 kinase activity inhibition with tumor response.
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2 years post treatment
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evaluate risk of infection
Time Frame: 2 years post treatment
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To evaluate the effect of this combination therapy on lymphocyte subsets and memory T-cells, and to correlate that with risk of infection.
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2 years post treatment
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Muna Qayed, MD, Children's Healthcare of Atlanta
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Neoplasms, Glandular and Epithelial
- Eye Diseases
- Retinal Diseases
- Genetic Diseases, Inborn
- Glioma
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Kidney Neoplasms
- Eye Diseases, Hereditary
- Neoplastic Syndromes, Hereditary
- Neoplasms, Complex and Mixed
- Neoplasms, Bone Tissue
- Neoplasms, Connective Tissue
- Neuroectodermal Tumors, Primitive
- Neoplasms, Muscle Tissue
- Neuroectodermal Tumors, Primitive, Peripheral
- Eye Neoplasms
- Retinal Neoplasms
- Myosarcoma
- Neoplasms
- Sarcoma
- Sarcoma, Ewing
- Ependymoma
- Medulloblastoma
- Rhabdoid Tumor
- Osteosarcoma
- Astrocytoma
- Neuroblastoma
- Retinoblastoma
- Rhabdomyosarcoma
- Wilms Tumor
- Hepatoblastoma
- Sarcoma, Clear Cell
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antifungal Agents
- Sirolimus
Other Study ID Numbers
- IRB00047016
- Aflac ST0901 CHOANOME (Other Identifier: Other)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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