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NCT01055314 · ClinicalTrials.gov registry record · Phase 2
Temozolomide, Cixutumumab, and Combination Chemotherapy in Treating Patients With Metastatic Rhabdomyosarcoma
A Phase 2 study of Stage IV Adult Soft Tissue Sarcoma and Adult Rhabdomyosarcoma, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 175
- Enrollment target
- 20
- Study locations
NCT01055314 is a Phase 2 study of Stage IV Adult Soft Tissue Sarcoma and Adult Rhabdomyosarcoma that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 175 participants, above the 56-participant average among 6 other Stage IV Adult Soft Tissue Sarcoma trials with a reported enrollment target (213% higher). The trial reports 20 study locations across 6 states.
The verdict
NCT01055314, a Phase 2 study of Stage IV Adult Soft Tissue Sarcoma and Adult Rhabdomyosarcoma, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 175 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized pilot clinical trial is studying the side effects and how well giving temozolomide and cixutumumab together with combination chemotherapy works in treating patients with metastatic rhabdomyosarcoma. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving temozolomide and cixutumumab together with combination chemotherapy may kill more tumor cells.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Doxorubicin Hydrochloride
- DRUG Etoposide
- BIOLOGICAL Dactinomycin
- BIOLOGICAL Cixutumumab
Study Locations (20)
California
- Southern California Permanente Medical Group - Downey
- Miller Children's and Women's Hospital Long Beach - Long Beach
- Children's Hospital Los Angeles - Los Angeles
- David Geffen School of Medicine at UCLA - Los Angeles
- Mattel Children's Hospital UCLA - Los Angeles
- Children's Hospital Central California - Madera
- Children's Hospital and Research Center at Oakland - Oakland
- Kaiser Permanente-Oakland - Oakland
- Childrens Hospital of Orange County - Orange
- Lucile Packard Children's Hospital Stanford University - Palo Alto
- Rady Children's Hospital - San Diego - San Diego
- UCSF Medical Center-Parnassus - San Francisco
Alabama
- Children's Hospital of Alabama - Birmingham
- University of Alabama at Birmingham Cancer Center - Birmingham
Colorado
- Children's Hospital Colorado - Aurora
- Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center - Denver
Connecticut
- Connecticut Children's Medical Center - Hartford
- Yale University - New Haven
Arizona
- Phoenix Childrens Hospital - Phoenix
Arkansas
- Arkansas Children's Hospital - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 175 participants |
| Start Date | 2010-01 |
| Est. Completion | 2016-06 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01055314
The ClinicalTrials.gov registry entry for NCT01055314 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 175 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 56-participant average among 6 other Stage IV Adult Soft Tissue Sarcoma trials with a reported enrollment target (213% higher). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Stage IV Adult Soft Tissue Sarcoma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT01055314 reports 20 study locations spanning 6 distinct geographic areas - top geographies include California, Alabama, Colorado.
Frequently Asked Questions
What is clinical trial NCT01055314 about?
NCT01055314 is a clinical study titled "Temozolomide, Cixutumumab, and Combination Chemotherapy in Treating Patients With Metastatic Rhabdomyosarcoma". This randomized pilot clinical trial is studying the side effects and how well giving temozolomide and cixutumumab together with combination chemotherapy works in treating patients with metastatic rhabdomyosarcoma. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the ...
What is the current status of trial NCT01055314?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 175 participants. The study started on 2010-01. Estimated completion is 2016-06.
What conditions does trial NCT01055314 study?
This clinical trial studies the following conditions: Stage IV Adult Soft Tissue Sarcoma, Adult Rhabdomyosarcoma, Childhood Alveolar Rhabdomyosarcoma, Childhood Embryonal Rhabdomyosarcoma, Metastatic Childhood Soft Tissue Sarcoma.
What interventions are being tested in trial NCT01055314?
The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin Hydrochloride (DRUG), Etoposide (DRUG), Dactinomycin (BIOLOGICAL), Cixutumumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01055314?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01055314 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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