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Study of Doxorubicin and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) and Intraoperative Brachytherapy for Unresectable or Refractory Pelvic and Abdominal Rhabdomyosarcoma and Undifferentiated Sarcomas in Children

NCT03111069 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2018-07-20

No results posted yet for this study

Summary

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.

Conditions

  • Malignant Neoplasms of Mesothelial and Soft Tissue
  • Rhabdomyosarcoma, Pelvic
  • Rhabdomyosarcoma, Abdominal

Interventions

PROCEDURE

Abdominal Surgery

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.

DRUG

Doxorubicin

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.

RADIATION

Intra-Operative Radiation

Standard dose brachytherapy delivered to the residual pelvic tumor sites.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Andrea Hayes-Jordan, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-31
Primary Completion
2021-08-31
Completion
2021-08-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03111069 on ClinicalTrials.gov