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NCT01946529 · ClinicalTrials.gov registry record · Phase 2
Therapeutic Trial for Patients With Ewing Sarcoma Family of Tumor and Desmoplastic Small Round Cell Tumors
A Phase 2 study of Desmoplastic Small Round Cell Tumor and Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, sponsored by St. Jude Children's Research Hospital.
- Active
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT01946529: Active Phase 2 study of Desmoplastic Small Round Cell Tumor and Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, sponsored by St. Jude Children's Research Hospital.
NCT01946529 is a Phase 2 study of Desmoplastic Small Round Cell Tumor and Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor that is active but no longer recruiting, run by St. Jude Children's Research Hospital. The registered enrollment target is 24 participants, below the 71-participant average among 7 other Desmoplastic Small Round Cell Tumor trials with a reported enrollment target (66% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01946529, a Phase 2 study of Desmoplastic Small Round Cell Tumor and Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, is active but no longer recruiting, sponsored by St. Jude Children's Research Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
This protocol will study treatment for Ewing sarcoma family of tumors (ESFT) and desmoplastic small round cell tumor (DSRCT). Participants with ESFT will be divided into two treatment groups, A or B, based on tumor characteristics. Group A (standard risk) participants have tumor that is not in the pelvis, has not spread to other parts of the body, and are less than 14 years of age. Because previous clinical trials have shown that standard treatment is very effective for children whose tumors have these characteristics, these participants will receive standard treatment. Group B (high risk) participants are 14 years of age or older or have tumor in the pelvis, or the tumor has spread to other parts of the body. Participants with DSRCT in the abdomen and/or pelvis or with tumor that cannot be removed by surgery alone or has spread to other parts of the body will be included in Group B. Participants in this group are considered high risk because there is a greater chance of tumor recurring following standard treatments currently in use. All participants will be followed and evaluated for 10 years following completion of therapy.
Primary Outcome
Response rate will be defined as the proportion of patients who achieved complete response or partial response (CR+PR) using the World Health Organization (WHO) criteria evaluated after two initial courses of temsirolimus, temozolomide and irinotecan in previously untreated patients with high risk Ewing Sarcoma Family of Tumor (ESFT). Participants who are treated in Group B with Desmoplastic Small Round Cell Tumor (DSRCT) or those who do not receive window therapy will not be included in this an
Conditions Studied
Interventions
- DRUG cyclophosphamide
- DRUG doxorubicin
- DRUG etoposide
- DRUG ifosfamide
- DRUG vincristine
Study Locations (1)
Tennessee
- St. Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2013-12-27 |
| Est. Completion | 2026-07 |
| Phase | Phase 2 |
What the registry record for NCT01946529 still lists
NCT01946529 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 71-participant average among 7 other Desmoplastic Small Round Cell Tumor trials with a reported enrollment target (66% lower).
The record links to 4 conditions, with Desmoplastic Small Round Cell Tumor appearing as the primary indexed condition, and to 5 interventions - of which cyclophosphamide is the first listed.
NCT01946529 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT01946529 about?
NCT01946529 is a clinical study titled "Therapeutic Trial for Patients With Ewing Sarcoma Family of Tumor and Desmoplastic Small Round Cell Tumors". This protocol will study treatment for Ewing sarcoma family of tumors (ESFT) and desmoplastic small round cell tumor (DSRCT). Participants with ESFT will be divided into two treatment groups, A or B, based on tumor characteristics. Group A (standard risk) participants have tumor that is not in the ...
What is the current status of trial NCT01946529?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2013-12-27. Estimated completion is 2026-07.
What conditions does trial NCT01946529 study?
This clinical trial studies the following conditions: Desmoplastic Small Round Cell Tumor, Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Localized Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Ewing Sarcoma of Bone or Soft Tissue.
What interventions are being tested in trial NCT01946529?
The interventions under investigation include: cyclophosphamide (DRUG), doxorubicin (DRUG), etoposide (DRUG), ifosfamide (DRUG), vincristine (DRUG).
Who is sponsoring clinical trial NCT01946529?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01946529 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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