NCT03111069|WithdrawnPhase 1FDA Drug
Study Stopped
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A Phase I Study of Doxorubicin and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) and Intraoperative Brachytherapy for Unresectable or Refractory Pelvic and Abdominal Rhabdomyosarcoma and Undifferentiated Sarcomas in Children
Sponsor study identifier
Secondary identifiers
REGISTRY · NCI CTRP
interventional
0
0 countries
N/A
Study Start
August 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
August 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The goal of this clinical research study is to find the highest tolerable dose of heated doxorubicin that can be given to patients during surgery with abdominal tumors. The safety of this drug will also be studied.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 6, 2017
Actual (reported)April 12, 2017
Actual (reported)August 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Maximum Tolerated Dose (MTD) of Doxorubicin and Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
MTD defined as the highest dose in which 1 or fewer patients in 6 treated experience a dose limiting toxicity (DLT). Hematologic DLT defined as Grade IV neutropenia, anemia, or thrombocytopenia per Common Toxicity Criteria. Non-hematologic DLT is any Grade III or IV non-hematologic toxicity excluding Grade III nausea or vomiting, Grade III hepatic toxicity which returns to Grade I within two weeks of the HIPEC, or before hospital discharge, or Grade III fever occurring after the HIPEC per Common Toxicity Criteria.
1 day
Progression of Disease
6 months
Participants receive complete surgical tumor resection with no gross residual disease, followed by hyperthermic intra-peritoneal chemotherapy (HIPEC) using Doxorubicin.
Participants receive debulking surgery followed by intra-operative radiation (IORT) in the form of brachytherapy to the gross residual pelvic tumor sites. Participants have the option of returning for HIPEC 4 weeks (or more) after IORT, if active disease remains.
Resectable Intra-Abdominal/Pelvic Tumors Group: Participants receive peritonectomy, omentectomy, cytoreduction, (complete surgical tumor resection, no gross residual disease). Unresectable Intra-Abdominal/Pelvic Tumors Group: Participants receive debulking surgery (90% resection) , with no more than 5mm thick residual implants, totaling no more than 2.5cm2 of residual tumor.
Andrea Hayes-Jordan, MD
M.D. Anderson Cancer Center
0 participants (actual enrollment reported by the registry).
First Submitted
April 6, 2017
First Posted
April 12, 2017
Study Start
August 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Dose Escalation: Heated Doxorubicin delivered by Hyperthermic Intraperitoneal Chemotherapy (HIPEC). After abdominal surgery two large bore catheters are placed in the peritoneal cavity through the incision. Starting dose of Doxorubicin is 15 mg/L of HIPEC perfusate. Dose Expansion Starting Dose: MTD from Dose Escalation.
Standard dose brachytherapy delivered to the residual pelvic tumor sites.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
August 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 20, 2018
Record last verified: 2018-07
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Source: ClinicalTrials.gov.
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