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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

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ClinicalTrials.gov Identifier: NCT03111069
Recruitment Status : Withdrawn (PI withdrew study)
First Posted : April 12, 2017
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Malignant Neoplasms of Mesothelial and Soft Tissue Rhabdomyosarcoma, Pelvic Rhabdomyosarcoma, Abdominal Procedure: Abdominal Surgery Drug: Doxorubicin Radiation: Intra-Operative Radiation Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : August 2018
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021


Arm Intervention/treatment
Experimental: Resectable Intra-Abdominal/Pelvic Tumors
Participants receive complete surgical tumor resection with no gross residual disease, followed by hyperthermic intra-peritoneal chemotherapy (HIPEC) using Doxorubicin.
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.

Other Names:
  • Doxorubicin Hydrochloride
  • Adriamycin PFS
  • Adriamycin RDF
  • Adriamycin
  • Rubex

Experimental: Unresectable Intra-Abdominal/Pelvic Tumors

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.

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.


Radiation: Intra-Operative Radiation
Standard dose brachytherapy delivered to the residual pelvic tumor sites.
Other Name: IORT




Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) of Doxorubicin and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) [ Time Frame: 1 day ]

    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.



Secondary Outcome Measures :
  1. Progression of Disease [ Time Frame: 6 months ]
    Disease progression defined by radio graphically visible nodules greater than 1.5 cm.



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 1-6 years inclusive
  2. Histologically proven RMS (with fusion status) or undifferentiated sarcoma of the pelvis or abdomen, group 3 (as defined by the IRS, intergroup rhabdomyosarcoma study group staging system seen in addendum 1)
  3. Radiologic workup must demonstrate that the disease is confined to the abdominal cavity and/or is not metabolically active on PET (Positron Emission Tomography scan), outside of the abdominal cavity.
  4. Patients must have a minimum expected duration of survival of greater than 6 weeks as determined and documented by the attending surgeon or medical oncologist.
  5. Patients must not have any systemic illness which precludes them from being an operative candidate as determined by anesthesia preoperative evaluation. This includes but is not limited to, sepsis, liver failure, renal failure, cardiovascular failure, pulmonary failure.
  6. Patients must have fully intact mental status and normal neurologic abilities. Intact mental status is defined by 'the capacity to identify and recall one's identity and place in time and space. Assessment of mental status and documentation of fully intact mental status by pediatric criteria, will be completed using physical and mental exam by the referring doctor or oncologist.
  7. Patients must have adequate renal function defined as creatinine clearance or radioisotope GFR (glomerular filtration rate) >/=70mL/min/1.73m^2 or a serum creatinine based on age/gender less than the listed value in the table below: 1 to <2 years 0.6mg/dL for both males and females, 2 to <6 years 0.8mg/dL for both males and females, 6 to <10 years 1.0mg/dL for both males and females
  8. Patients will be eligible if the WBC (white blood cell count) is ≥2000/µl or ANC (absolute neutrophil count) is ≥1,500 and platelets are ≥ 100,000/mm3
  9. Patients will be eligible if serum total bilirubin and liver enzymes are ≤ 2 times the upper limit of normal
  10. Patients must be recovered from any toxicity from all prior chemotherapy, immunotherapy, or radiotherapy and be at least 14 days past the date of their last treatment

Exclusion Criteria:

  1. Patients will be ineligible if they have any concomitant cardiopulmonary disease which would place them at unacceptable risk for a major surgical procedure
  2. Patients will be ineligible if they have disease outside of the abdominal cavity which is uncontrolled or PET avid.
  3. Patients will be ineligible if they have a baseline neurologic toxicity of Grade 3 or greater.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03111069


Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Andrea Hayes-Jordan, MD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03111069     History of Changes
Other Study ID Numbers: 2016-0756
NCI-2018-01216 ( Registry Identifier: NCI CTRP )
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Malignant neoplasms of mesothelial and soft tissue
Pelvic and Abdominal Rhabdomyosarcoma
Undifferentiated Sarcomas
Unresectable or Refractory
Abdominal tumors
Hyperthermic intra-peritoneal chemotherapy
HIPEC
Abdominal surgery
Doxorubicin
Doxorubicin Hydrochloride
Adriamycin PFS
Adriamycin RDF
Adriamycin
Rubex
Intra-operative radiation
IORT
Brachytherapy
Additional relevant MeSH terms:
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Sarcoma
Rhabdomyosarcoma
Fever
Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Myosarcoma
Neoplasms, Muscle Tissue
Body Temperature Changes
Signs and Symptoms
Doxorubicin
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action