Advanced CancersPhase 2NCT01277744
Pilot Study of Hyperthermic Peritoneal Perfusion (HIPEC) for Adolescent and Young Adults With Desmoplastic Small Round Cell Tumor
A Phase 2 study testing Hyperthermic Peritoneal Perfusion (HIPEC) and Cisplatin in people with Advanced Cancers and Sarcoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if heated intra-abdominal cisplatin can help to control abdominal tumors in patients having surgery to remove the tumors. The safety of this drug will also be studied. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Advanced Cancers, Sarcoma
- What is being tested?
- Hyperthermic Peritoneal Perfusion (HIPEC) and Cisplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2011to 16 Feb 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age greater than or equal to 1 years
- Histologically or genetically proven diffuse peritoneal or retroperitoneal tumor from desmoplastic round cell tumor, ovarian germ cell, sarcoma, Wilms' tumor, or other non-carcinoma tumors.
- Radiologic workup must demonstrate that the disease is confined to the abdominal cavity
- Radiologic workup or prior abdominal exploration must be consistent with disease which can be debulked to a residual size of less than or equal to 1 cm thickness per tumor deposit
- 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, pregnant or lactating females.
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- 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 will be completed using physical and mental exam by the referring doctor or oncologist.
- Patients must have adequate renal function (serum creatinine </= 1.5 mg/dl without history dialysis or renal failure or creatinine clearance less than 50 mL/min/1.73M^2 if less than 5 years of age)
- Patients will be eligible if the white blood cell count (WBC) is >/=2000/microliter or absolute neutrophil count (ANC) is >/=1,500 and platelets are >/= 100,000/mm^3
- 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
- Patients will be ineligible if they have a baseline neurologic toxicity of Grade 3 or greater (because of the potential neurotoxicity associated with platinum)
- Patients who have failed previous intraperitoneal platinum therapy will be ineligible
- Patients with Retroperitoneal Liposarcoma will be ineligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase II Study of Hyperthermic Peritoneal Perfusion (HIPEC) for Adolescent and Young Adults With Desmoplastic Small Round Cell Tumor and Other Non-Carcinomas
The goal of this clinical research study is to learn if heated intra-abdominal cisplatin can help to control abdominal tumors in patients having surgery to remove the tumors. The safety of this drug will also be studied.
Read the detailed description
The Study Drugs:
Cisplatin has a platinum atom at its center. The platinum is supposed to poison the cancer cells, which may cause them to die.
Surgery and Study Drug Administration:
If you are found to be eligible, the abdominal surgery will be performed to try to remove as many tumors as possible. The abdominal surgery is not being performed specifically for this research study and would be performed even if you didn't take part in this study. You will be given a separate consent form to sign that explains the details and risks of abdominal surgery in more detail.
During the surgery you will receive sodium thiosulfate by vein. The abdomen will then be temporarily closed. Then the abdominal wash will begin. During the "abdominal wash," heated cisplatin will be delivered through plastic tubing that is connected to a pump into the abdomen. The pump pushes the heated cisplatin into the abdomen and then pulls it out and recirculates the cisplatin. The skin of the abdomen is temporarily closed during the abdominal wash. The surgeon will also "wash" over the closed area of the surgical site. A pump will be used to pump heated cisplatin in and out of the abdomen over 90 minutes while the surgeon gently presses on the abdominal wall so the cisplatin reaches all areas in the abdomen. After 90 minutes, the cisplatin is removed and the abdomen will be "washed" with saline and all fluid will be removed before the surgeon permanently closes the abdomen with 3 layers of stitches.
Two (2) pea-sized tumor samples will be sent to the laboratory of Dr. Dina Lev for tissue evaluation and extraction of RNA (genetic material). One (1) tumor sample will be removed before the procedure and the other sample will be removed at the end of the procedure. The samples will be examined under a microscope and DNA (the genetic material in cells) will be removed to look for any changes to the DNA. The results of these tests will not be shared with you, nor will they be used for any decisions regarding your treatment. The samples will be destroyed after these tests are complete.
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, your doctor will discuss other treatment options with you.
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.
- You will have a physical exam, including measurement of your weight and vital signs.
Follow-Up Visits:
About 1, 3, and 6 months after the surgery is complete, you will have follow-up visits and the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your weight and vital signs.
- Blood (about 1 teaspoon) will be drawn at the 1 month visit only for routine tests.
- You will have a hearing test at the 1 month visit only.
- Blood (about 3 teaspoons) will be drawn for routine tests at the 3 and 6 month visits only.
- At the 3 and 6 month visits only, you will have a CT scan, positron emission tomography (PET)-CT scan, or MRI scan to check the status of the disease.
Length of Study:
You will remain on study for up to 6 months. You 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, you may be eligible for a re-perfusion, which is a repeat of the operation and study drug administration. If you are eligible for a re-perfusion, your participation on this study will end and then you will be given a new consent form to sign in order to be re-enrolled back onto this study.
This is an investigational study. Cisplatin is FDA-approved and commercially available for the treatment of advanced bladder cancer, metastatic testicular cancer, metastatic ovarian cancer, hepatoblastoma, neuroblastoma, metastatic appendiceal cancer, and abdominal mesothelioma. The use of cisplatin in patients with abdominal sarcoma-type tumors is investigational.
Up to 22 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Advanced Cancers, Sarcoma
- Being tested
- Hyperthermic Peritoneal Perfusion (HIPEC), Cisplatin
- Keywords
- Desmoplastic small round cell tumor, DSRCT, Hyperthermic peritoneal perfusion, HIPEC, Complete abdominal tumor excision, Extensive abdominal disease, Non-carcinoma tumors, Abdominal cavity, Cisplatin, Platinol-AQ, Platinol, CDDP, Diffuse peritoneal tumor, Retroperitoneal tumor, Ovarian germ cell, Wilms' tumor
- Medical subject headings
- Sarcoma, Desmoplastic Small Round Cell Tumor, Wilms Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperthermic Peritoneal Perfusion (HIPEC)Procedure or surgery
HIPEC, technique for combining hyperthermia and chemotherapeutic agents delivered intraoperatively to the peritoneal and retroperitoneal surface via a recirculating perfusion circuit, performed after cytoreductive surgery and lysis of adhesions.
CisplatinDrug
Also called Platinol-AQ, Platinol, CDDP
100 mg/M2 per perfusion catheter. The perfusion is continued for 90 minutes after adding the cisplatin.
| Study group | Role | What they receive |
|---|---|---|
| HIPEC + Cisplatin | Experimental | HIPEC, technique for combining hyperthermia and chemotherapeutic agents delivered intraoperatively to the peritoneal and retroperitoneal surface via a recirculating perfusion circuit, performed after cytoreductive surgery and lysis of adhesions. Cisplatin 100 mg/M2 per perfusion catheter. The perfusion is continued for 90 minutes after adding the Cisplatin. Receives: Procedure: Hyperthermic Peritoneal Perfusion (HIPEC); Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence Free Survival
Date of surgery to date of death or date of recurrence, whichever occurred first for patients who experienced an event, and to date of last follow-up for patients alive without recurrence
Measured: 36 months after the last participant enrolled
Secondary outcomes (1)
Overall Survival
From the date of diagnosis to the date of death or last follow up date for patient alive.
Measured: From the date of diagnosis to the date of death or last follow up date for patient alive up to 81 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2011 (estimated)
- Study start9 May 2011
- Primary completion16 Feb 2018
- Study completion16 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced CancersStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 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
- NCT01277744
- Sponsor's protocol ID
- 2009-0528
- Other IDs
- NCI-2011-00245
- Status last verified
- Jan 2020
- First submitted
- 12 Jan 2011
- Last updated
- 13 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- 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 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Hyperthermic Peritoneal Perfusion (HIPEC) for Adolescent and Young Adults With Desmoplastic Small Round Cell Tumor and Other Non-Carcinomas
- ClinicalTrials.gov ID
- NCT01277744
- Acronym / sponsor ID
- 2009-0528
- Conditions
- Advanced Cancers, Sarcoma
- Keywords
- Desmoplastic small round cell tumor, DSRCT, Hyperthermic peritoneal perfusion, HIPEC, Complete abdominal tumor excision, Extensive abdominal disease, Non-carcinoma tumors, Abdominal cavity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 9 May 2011 (actual)
- Primary completion
- 16 Feb 2018 (actual)
- Study completion
- 16 Feb 2018 (actual)
- First posted
- 17 Jan 2011 (estimated)
- Results
- Posted 1 Oct 2019
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 learn if heated intra-abdominal cisplatin can help to control abdominal tumors in patients having surgery to remove the tumors. The safety of this drug will also be studied.
Detailed description
The Study Drugs:
Cisplatin has a platinum atom at its center. The platinum is supposed to poison the cancer cells, which may cause them to die.
Surgery and Study Drug Administration:
If you are found to be eligible, the abdominal surgery will be performed to try to remove as many tumors as possible. The abdominal surgery is not being performed specifically for this research study and would be performed even if you didn't take part in this study. You will be given a separate consent form to sign that explains the details and risks of abdominal surgery in more detail.
During the surgery you will receive sodium thiosulfate by vein. The abdomen will then be temporarily closed. Then the abdominal wash will begin. During the "abdominal wash," heated cisplatin will be delivered through plastic tubing that is connected to a pump into the abdomen. The pump pushes the heated cisplatin into the abdomen and then pulls it out and recirculates the cisplatin. The skin of the abdomen is temporarily closed during the abdominal wash. The surgeon will also "wash" over the closed area of the surgical site. A pump will be used to pump heated cisplatin in and out of the abdomen over 90 minutes while the surgeon gently presses on the abdominal wall so the cisplatin reaches all areas in the abdomen. After 90 minutes, the cisplatin is removed and the abdomen will be "washed" with saline and all fluid will be removed before the surgeon permanently closes the abdomen with 3 layers of stitches.
Two (2) pea-sized tumor samples will be sent to the laboratory of Dr. Dina Lev for tissue evaluation and extraction of RNA (genetic material). One (1) tumor sample will be removed before the procedure and the other sample will be removed at the end of the procedure. The samples will be examined under a microscope and DNA (the genetic material in cells) will be removed to look for any changes to the DNA. The results of these tests will not be shared with you, nor will they be used for any decisions regarding your treatment. The samples will be destroyed after these tests are complete.
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, your doctor will discuss other treatment options with you.
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.
- You will have a physical exam, including measurement of your weight and vital signs.
Follow-Up Visits:
About 1, 3, and 6 months after the surgery is complete, you will have follow-up visits and the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your weight and vital signs.
- Blood (about 1 teaspoon) will be drawn at the 1 month visit only for routine tests.
- You will have a hearing test at the 1 month visit only.
- Blood (about 3 teaspoons) will be drawn for routine tests at the 3 and 6 month visits only.
- At the 3 and 6 month visits only, you will have a CT scan, positron emission tomography (PET)-CT scan, or MRI scan to check the status of the disease.
Length of Study:
You will remain on study for up to 6 months. You 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, you may be eligible for a re-perfusion, which is a repeat of the operation and study drug administration. If you are eligible for a re-perfusion, your participation on this study will end and then you will be given a new consent form to sign in order to be re-enrolled back onto this study.
This is an investigational study. Cisplatin is FDA-approved and commercially available for the treatment of advanced bladder cancer, metastatic testicular cancer, metastatic ovarian cancer, hepatoblastoma, neuroblastoma, metastatic appendiceal cancer, and abdominal mesothelioma. The use of cisplatin in patients with abdominal sarcoma-type tumors is investigational.
Up to 22 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIPEC + Cisplatin | Experimental | Procedure: Hyperthermic Peritoneal Perfusion (HIPEC), Drug: CisplatinHIPEC, technique for combining hyperthermia and chemotherapeutic agents delivered intraoperatively to the peritoneal and retroperitoneal surface via a recirculating perfusion circuit, performed after cytoreductive surgery and lysis of adhesions. Cisplatin 100 mg/M2 per perfusion catheter. The perfusion is continued for 90 minutes after adding the Cisplatin. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Age greater than or equal to 1 years
- Histologically or genetically proven diffuse peritoneal or retroperitoneal tumor from desmoplastic round cell tumor, ovarian germ cell, sarcoma, Wilms' tumor, or other non-carcinoma tumors.
- Radiologic workup must demonstrate that the disease is confined to the abdominal cavity
- Radiologic workup or prior abdominal exploration must be consistent with disease which can be debulked to a residual size of less than or equal to 1 cm thickness per tumor deposit
- 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.
Key exclusion criteria (5 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
- Patients will be ineligible if they have a baseline neurologic toxicity of Grade 3 or greater (because of the potential neurotoxicity associated with platinum)
- Patients who have failed previous intraperitoneal platinum therapy will be ineligible
- Patients with Retroperitoneal Liposarcoma will be ineligible.
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 |
|---|---|---|
| Hyperthermic Peritoneal Perfusion (HIPEC)HIPEC, technique for combining hyperthermia and chemotherapeutic agents delivered intraoperatively to the peritoneal and retroperitoneal surface via a recirculating perfusion circuit, performed after cytoreductive surgery and lysis of adhesions. | Procedure or surgery | HIPEC + Cisplatin |
| CisplatinAlso: Platinol-AQ, Platinol, CDDP100 mg/M2 per perfusion catheter. The perfusion is continued for 90 minutes after adding the cisplatin. | Drug | HIPEC + Cisplatin |
Primary outcome
Recurrence Free Survival
Time frame: 36 months after the last participant enrolled
Date of surgery to date of death or date of recurrence, whichever occurred first for patients who experienced an event, and to date of last follow-up for patients alive without recurrence
1 secondary outcome
Overall Survival
Time frame: From the date of diagnosis to the date of death or last follow up date for patient alive up to 81 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hyperthermic Peritoneal Perfusion (HIPEC) and Cisplatin in people with Advanced Cancers and Sarcoma, run by M.D. Anderson Cancer Center at 1 site in United States.
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 11 inclusion and 5 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: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Recurrence Free Survival (time frame: 36 months after the last participant enrolled). 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 13 Jan 2020.