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Completed Phase 1Phase 2 Interventional

Study of ZIO-201 in Advanced Sarcoma

NCT00439686
Conditions
Advanced Sarcoma
Interventions
ZIO-201
Drug
Lead sponsor
Alaunos Therapeutics
Industry
Eligibility
18 Years and older
Enrollment
53 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2013
U.S. locations
2
States / cities
Santa Monica, California • Ann Arbor, Michigan
Conditions
Malignancy, Cancer, Non Small Cell Lung Cancer, Small Cell Lung Cancer, Testicular Cancer, Thymoma, Ovarian Cancer, Osteosarcoma
Interventions
palifosfamide-tris
Drug
Lead sponsor
Alaunos Therapeutics
Industry
Eligibility
18 Years and older
Enrollment
12 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2012
U.S. locations
4
States / cities
Indianapolis, Indiana • Lafayette, Indiana • Muncie, Indiana + 1 more
Conditions
Extensive-Stage Small Cell Lung Cancer
Interventions
Carboplatin, Palifosfamide-tris, Etoposide
Drug
Lead sponsor
Alaunos Therapeutics
Industry
Eligibility
18 Years and older
Enrollment
548 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2015
U.S. locations
40
States / cities
Birmingham, Alabama • Los Angeles, California • Santa Rosa, California + 36 more
Conditions
Central Nervous System Nongerminomatous Germ Cell Tumor, Choriocarcinoma, Embryonal Carcinoma, Immature Teratoma, Malignant Teratoma, Mixed Germ Cell Tumor, Pineal Region Germ Cell Tumor, Pineal Region Immature Teratoma, Pineal Region Yolk Sac Tumor, Suprasellar Germ Cell Tumor
Interventions
Biospecimen Collection, Carboplatin, Etoposide, Filgrastim, Ifosfamide, Magnetic Resonance Imaging, Mesna, Pegfilgrastim, Peripheral Blood Stem Cell Transplantation, Questionnaire Administration, Radiation Therapy, Second-Look Surgery, Thiotepa
Procedure · Drug · Biological + 2 more
Lead sponsor
Children's Oncology Group
Network
Eligibility
3 Years to 29 Years
Enrollment
160 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2029
U.S. locations
152
States / cities
Birmingham, Alabama • Anchorage, Alaska • Mesa, Arizona + 120 more
Conditions
Adult Central Nervous System Germ Cell Tumor, Adult Teratoma, Malignant Extragonadal Germ Cell Tumor, Malignant Extragonadal Non-Seminomatous Germ Cell Tumor, Extragonadal Seminoma, Recurrent Malignant Testicular Germ Cell Tumor, Recurrent Ovarian Germ Cell Tumor, Stage IV Extragonadal Non-Seminomatous Germ Cell Tumor, Stage IV Extragonadal Seminoma, Stage IV Ovarian Germ Cell Tumor
Interventions
palifosfamide
Drug
Lead sponsor
Indiana University
Other
Eligibility
18 Years and older
Enrollment
5 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2014
U.S. locations
3
States / cities
Indianapolis, Indiana • Philadelphia, Pennsylvania • Seattle, Washington
Conditions
Soft Tissue Sarcoma
Interventions
Palifosfamide Tris and Doxorubicin, Doxorubicin
Drug
Lead sponsor
Alaunos Therapeutics
Industry
Eligibility
18 Years and older
Enrollment
67 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2014
U.S. locations
18
States / cities
Santa Monica, California • Washington D.C., District of Columbia • Tampa, Florida + 15 more
Conditions
Advanced Solid Tumors
Interventions
palifosfamide-tris, Normal Saline
Drug
Lead sponsor
Alaunos Therapeutics
Industry
Eligibility
18 Years and older
Enrollment
24 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2013
U.S. locations
3
States / cities
Dallas, Texas • Houston, Texas • San Antonio, Texas
Conditions
Breast Cancer Nos Metastatic Recurrent
Interventions
Ad-RTS-hIL-12 and Veledimex, Palifosfamide
Genetic · Drug
Lead sponsor
Alaunos Therapeutics
Industry
Eligibility
18 Years and older
Enrollment
12 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2014
U.S. locations
8
States / cities
Jacksonville, Florida • Detroit, Michigan • Billings, Montana + 5 more
Conditions
Soft Tissue Sarcoma
Interventions
doxorubicin in combination with palifosfamide-tris, doxorubicin in combination with placebo
Drug
Lead sponsor
Alaunos Therapeutics
Industry
Eligibility
18 Years and older
Enrollment
447 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2013
U.S. locations
73
States / cities
Birmingham, Alabama • Phoenix, Arizona • Scottsdale, Arizona + 65 more
Conditions
Advanced Cancer
Interventions
ZIO-201
Drug
Lead sponsor
Alaunos Therapeutics
Industry
Eligibility
18 Years and older
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2007
U.S. locations
2
States / cities
Santa Monica, California • Detroit, Michigan