Malignant Neoplasms of Mesothelial and Soft TissuePhase 1NCT03111069
Study of Doxorubicin and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) and Intraoperative Brachytherapy for Unresectable or Refractory Pelvic and Abdominal Rhabdomyosarcoma and Undifferentiated Sarcomas in Children
A Phase 1 study testing Abdominal Surgery, Doxorubicin and Intra-Operative Radiation in people with Malignant Neoplasms of Mesothelial and Soft Tissue and Rhabdomyosarcoma, Pelvic, run by M.D. Anderson Cancer Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Malignant Neoplasms of Mesothelial and Soft Tissue, Rhabdomyosarcoma, Pelvic, Rhabdomyosarcoma, Abdominal
- What is being tested?
- Abdominal Surgery, Doxorubicin and Intra-Operative Radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2018to Aug 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 1-6 years inclusive
- 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)
- 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.
- 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.
- 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.
- 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.
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- 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
- 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
- Patients will be eligible if serum total bilirubin and liver enzymes are ≤ 2 times the upper limit of normal
- 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
Who cannot join
- Patients will be ineligible if they have any concomitant cardiopulmonary disease which would place them at unacceptable risk for a major surgical procedure
- Patients will be ineligible if they have disease outside of the abdominal cavity which is uncontrolled or PET avid.
- Patients will be ineligible if they have a baseline neurologic toxicity of Grade 3 or greater.
About this study
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
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.
Read the detailed description
Surgery and Study Drug Administration:
If participant is found to be eligible to take part in this study, surgery will be performed to try to remove as many tumors from participant's abdomen as possible. The surgery is not being performed specifically for this research study and would be performed as part of participant's standard of care treatment even if participant didn't take part in this study. Participant will be given a separate consent form to sign that explains the details and risks of the abdominal surgery in more detail.
During the surgery, if it is decided that all of the tumors can be removed, the abdomen will be closed with a plastic tube left in place. Then, the abdominal wash will begin. During the wash, a pump that is connected to the plastic tube pushes the heated doxorubicin into the abdomen and then pulls it out to recirculate the doxorubicin. The heated doxorubicin will be recirculated in and out of the abdomen over 90 minutes while the surgeon gently presses on the abdomen to help the doxorubicin reach all areas in the abdomen. The plastic tube that the heated doxorubicin will be pumped through will stay in place after the surgery to drain the extra fluid. These are the same plastic tubes that would be present even if participant did not agree to take part in this study.
There is a chance that the surgeon may decide during the surgery that the abdominal wash will not be performed, for example if the disease has spread to or attached to certain organs. If this occurs, as many of the tumors will be removed as possible, followed by brachytherapy and the implantation of radioactive seeds. To perform brachytherapy, straws loaded with radioactive seeds will be inserted into the abdominal area. The radiation will then take place in the operating room over about 20 minutes. The straws will be removed before ending the surgery. Participant may be able to return for the abdominal wash procedure 4 weeks after the seeds have been implanted.
Pharmacokinetic Testing:
During participant's surgery, extra blood (about ½ teaspoon each time) and fluid from the abdominal area will be collected for pharmacokinetic (PK) testing when participant begins to receive the first infusion of the heated doxorubicin then 30, 60 and 90 minutes after the infusion has started, and again 24 hours after receiving the heated doxorubicin. The blood and fluid from the abdominal area will be collected through already placed catheters, so no additional needle sticks will be required. PK testing measures the amount of study drug in the body at different time points.
Length of Study:
Participant will remain on study for up to 6 months. Participant will be taken off study if the disease gets worse.
If the study doctor learns that the disease has come back or gotten worse at the 6 month follow-up visit, participant may be eligible to have the operation with heated doxorubicin wash repeated. If participant is eligible to have the surgery repeated, participant's active participation on this study will end and then participant will be given a new consent form to sign in order to be re-enrolled back onto this study.
Study Visits:
On Days 1-5, 11, and 14, (Day 1 being the day after surgery):
- Blood (about 1 teaspoon) will be drawn for routine tests.
- Participant will have a physical exam.
Follow-Up Visits:
About 1, 3, and 6 months after the surgery is complete, participant will have a follow-up visit and the following tests and procedures will be performed:
- Participant will have a physical exam.
- Blood (about 1-3 teaspoons) will be drawn for routine tests.
- Participant will have an ECHO to check your heart function.
It is recommended that participant has follow-up visits at MD Anderson at 3 and 6 months after surgery. In addition to blood draws (about 1-3 teaspoons each time), participant will have an MRI, CT, or PET-CT scan to check the status of the disease. These 3 and 6 month visits after surgery may be performed at participant's local doctor's office and/or laboratory.
This is an investigational study. Doxorubicin is FDA-approved and commercially available. The use of a heated doxorubicin wash during abdominal surgery in patients with tumors is investigational. The study doctor can explain how the study drug is designed to work.
Up to 28 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Malignant Neoplasms of Mesothelial and Soft Tissue, Rhabdomyosarcoma, Pelvic, Rhabdomyosarcoma, Abdominal
- Being tested
- Abdominal Surgery, Doxorubicin, Intra-Operative Radiation
- Keywords
- 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
- Medical subject headings
- Rhabdomyosarcoma, Abdominal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal SurgeryProcedure or 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.
DoxorubicinDrug
Also called Doxorubicin Hydrochloride, Adriamycin PFS, Adriamycin RDF, Adriamycin
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.
Intra-Operative RadiationRadiation
Also called IORT
Standard dose brachytherapy delivered to the residual pelvic tumor sites.
| Study group | Role | What they receive |
|---|---|---|
| Resectable Intra-Abdominal/Pelvic Tumors | Experimental | Participants receive complete surgical tumor resection with no gross residual disease, followed by hyperthermic intra-peritoneal chemotherapy (HIPEC) using Doxorubicin. Receives: Procedure: Abdominal Surgery; Drug: Doxorubicin |
| Unresectable Intra-Abdominal/Pelvic Tumors | Experimental | 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. Receives: Procedure: Abdominal Surgery; Radiation: Intra-Operative Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (1)
Progression of Disease
Disease progression defined by radio graphically visible nodules greater than 1.5 cm.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study startAug 2018 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionAug 2021 (estimated)
Why it stopped: PI withdrew study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Neoplasms of Mesothelial and Soft TissueStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Hayes-Jordan, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03111069
- Sponsor's protocol ID
- 2016-0756
- Other IDs
- NCI-2018-01216
- Status last verified
- Jul 2018
- First submitted
- 6 Apr 2017
- Last updated
- 20 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03111069
- Acronym / sponsor ID
- 2016-0756
- Conditions
- Malignant Neoplasms of Mesothelial and Soft Tissue, Rhabdomyosarcoma, Pelvic, Rhabdomyosarcoma, Abdominal
- Keywords
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI withdrew study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Aug 2018 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 12 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Surgery and Study Drug Administration:
If participant is found to be eligible to take part in this study, surgery will be performed to try to remove as many tumors from participant's abdomen as possible. The surgery is not being performed specifically for this research study and would be performed as part of participant's standard of care treatment even if participant didn't take part in this study. Participant will be given a separate consent form to sign that explains the details and risks of the abdominal surgery in more detail.
During the surgery, if it is decided that all of the tumors can be removed, the abdomen will be closed with a plastic tube left in place. Then, the abdominal wash will begin. During the wash, a pump that is connected to the plastic tube pushes the heated doxorubicin into the abdomen and then pulls it out to recirculate the doxorubicin. The heated doxorubicin will be recirculated in and out of the abdomen over 90 minutes while the surgeon gently presses on the abdomen to help the doxorubicin reach all areas in the abdomen. The plastic tube that the heated doxorubicin will be pumped through will stay in place after the surgery to drain the extra fluid. These are the same plastic tubes that would be present even if participant did not agree to take part in this study.
There is a chance that the surgeon may decide during the surgery that the abdominal wash will not be performed, for example if the disease has spread to or attached to certain organs. If this occurs, as many of the tumors will be removed as possible, followed by brachytherapy and the implantation of radioactive seeds. To perform brachytherapy, straws loaded with radioactive seeds will be inserted into the abdominal area. The radiation will then take place in the operating room over about 20 minutes. The straws will be removed before ending the surgery. Participant may be able to return for the abdominal wash procedure 4 weeks after the seeds have been implanted.
Pharmacokinetic Testing:
During participant's surgery, extra blood (about ½ teaspoon each time) and fluid from the abdominal area will be collected for pharmacokinetic (PK) testing when participant begins to receive the first infusion of the heated doxorubicin then 30, 60 and 90 minutes after the infusion has started, and again 24 hours after receiving the heated doxorubicin. The blood and fluid from the abdominal area will be collected through already placed catheters, so no additional needle sticks will be required. PK testing measures the amount of study drug in the body at different time points.
Length of Study:
Participant will remain on study for up to 6 months. Participant will be taken off study if the disease gets worse.
If the study doctor learns that the disease has come back or gotten worse at the 6 month follow-up visit, participant may be eligible to have the operation with heated doxorubicin wash repeated. If participant is eligible to have the surgery repeated, participant's active participation on this study will end and then participant will be given a new consent form to sign in order to be re-enrolled back onto this study.
Study Visits:
On Days 1-5, 11, and 14, (Day 1 being the day after surgery):
- Blood (about 1 teaspoon) will be drawn for routine tests.
- Participant will have a physical exam.
Follow-Up Visits:
About 1, 3, and 6 months after the surgery is complete, participant will have a follow-up visit and the following tests and procedures will be performed:
- Participant will have a physical exam.
- Blood (about 1-3 teaspoons) will be drawn for routine tests.
- Participant will have an ECHO to check your heart function.
It is recommended that participant has follow-up visits at MD Anderson at 3 and 6 months after surgery. In addition to blood draws (about 1-3 teaspoons each time), participant will have an MRI, CT, or PET-CT scan to check the status of the disease. These 3 and 6 month visits after surgery may be performed at participant's local doctor's office and/or laboratory.
This is an investigational study. Doxorubicin is FDA-approved and commercially available. The use of a heated doxorubicin wash during abdominal surgery in patients with tumors is investigational. The study doctor can explain how the study drug is designed to work.
Up to 28 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resectable Intra-Abdominal/Pelvic Tumors | Experimental | Procedure: Abdominal Surgery, Drug: DoxorubicinParticipants receive complete surgical tumor resection with no gross residual disease, followed by hyperthermic intra-peritoneal chemotherapy (HIPEC) using Doxorubicin. |
| Unresectable Intra-Abdominal/Pelvic Tumors | Experimental | Procedure: Abdominal Surgery, Radiation: Intra-Operative RadiationParticipants 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. |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Age 1-6 years inclusive
- 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)
- 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.
- 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.
- 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.
Key exclusion criteria (3 listed)
- Patients will be ineligible if they have any concomitant cardiopulmonary disease which would place them at unacceptable risk for a major surgical procedure
- Patients will be ineligible if they have disease outside of the abdominal cavity which is uncontrolled or PET avid.
- Patients will be ineligible if they have a baseline neurologic toxicity of Grade 3 or greater.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal SurgeryResectable 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. | Procedure or surgery | Resectable Intra-Abdominal/Pelvic Tumors, Unresectable Intra-Abdominal/Pelvic Tumors |
| DoxorubicinAlso: Doxorubicin Hydrochloride, Adriamycin PFS, Adriamycin RDF, AdriamycinDose 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. | Drug | Resectable Intra-Abdominal/Pelvic Tumors |
| Intra-Operative RadiationAlso: IORTStandard dose brachytherapy delivered to the residual pelvic tumor sites. | Radiation | Unresectable Intra-Abdominal/Pelvic Tumors |
Primary outcome
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.
1 secondary outcome
Progression of Disease
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2018.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Hayes-Jordan, MD principal investigator
M.D. Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Abdominal Surgery, Doxorubicin and Intra-Operative Radiation in people with Malignant Neoplasms of Mesothelial and Soft Tissue and Rhabdomyosarcoma, Pelvic, run by M.D. Anderson Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) of Doxorubicin and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2018.