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NCT01331135 · ClinicalTrials.gov registry record · Phase 1

Aflac ST0901 CHOANOME - Sirolimus in Solid Tumors

A Phase 1 study of Glioma and Osteosarcoma, sponsored by Emory University.

Completed
Registry status
Phase 1
Development phase
18
Enrollment target
1
Study location

NCT01331135 is a Phase 1 study of Glioma and Osteosarcoma that has completed, run by Emory University. The registered enrollment target is 18 participants, below the 210-participant average among 87 other Glioma trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01331135, a Phase 1 study of Glioma and Osteosarcoma, has completed, sponsored by Emory University.

COMPLETED
Registry status
Phase 1
Development phase
18 participants
Enrollment target
1
Study location

Study 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.

Interventions

  • DRUG sirolimus

Study Locations (1)

Georgia

  • Children's Healthcare of Atlanta - Atlanta

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2011-04
Est. Completion 2017-08-09
Phase Phase 1

Sponsor

Emory University

1,208 total trials

What the Registry Record Tells You About NCT01331135

The ClinicalTrials.gov registry entry for NCT01331135 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 210-participant average among 87 other Glioma trials with a reported enrollment target (91% lower). The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with Glioma appearing as the primary indexed condition, and to 1 intervention - of which sirolimus is the first listed.

NCT01331135 reports 1 study location spanning 1 distinct geographic area - top geographies include Georgia.

Frequently Asked Questions

What is clinical trial NCT01331135 about?

NCT01331135 is a clinical study titled "Aflac ST0901 CHOANOME - Sirolimus in Solid Tumors". 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. Th...

What is the current status of trial NCT01331135?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2011-04. Estimated completion is 2017-08-09.

What conditions does trial NCT01331135 study?

This clinical trial studies the following conditions: Glioma, Osteosarcoma, Medulloblastoma, Ependymoma, Astrocytoma.

What interventions are being tested in trial NCT01331135?

The interventions under investigation include: sirolimus (DRUG).

Who is sponsoring clinical trial NCT01331135?

This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01331135 being conducted?

This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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