Pilot Study of Hyperthermic Peritoneal Perfusion (HIPEC) for Adolescent and Young Adults With Desmoplastic Small Round Cell Tumor
This study is currently recruiting participants.
Verified March 2013 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01277744
First received: January 12, 2011
Last updated: March 29, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Cancers Sarcoma |
Procedure: Hyperthermic Peritoneal Perfusion (HIPEC) Drug: Cisplatin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Time to Relapse [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
About 1, 3, and 6 months after surgery is complete, follow-up visits and the following tests and procedures will be performed:
A CT scan, PET-CT scan, or MRI scan to check the status of the disease.
Efficacy assessed with primary endpoint of time to relapse.
| Estimated Enrollment: | 20 |
| Study Start Date: | May 2011 |
| Estimated Primary Completion Date: | March 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: HIPEC + Cisplatin
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.
|
Procedure: 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.
Drug: Cisplatin
100 mg/M2 per perfusion catheter. The perfusion is continued for 90 minutes after adding the cisplatin.
Other Names:
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Show Detailed Description
Eligibility| Ages Eligible for Study: | 1 Year and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
- 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 WBC is >/=2000/microliter or ANC is >/=1,500, or 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
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01277744
Contacts
| Contact: Andrea Hayes-Jordan, MD | 713-794-4616 |
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Principal Investigator: | Andrea Hayes-Jordan, MD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01277744 History of Changes |
| Other Study ID Numbers: | 2009-0528 |
| Study First Received: | January 12, 2011 |
| Last Updated: | March 29, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
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 |
Additional relevant MeSH terms:
|
Fever Desmoplastic Small Round Cell Tumor Neoplasms Sarcoma Body Temperature Changes Signs and Symptoms Neoplasms, Connective and Soft Tissue |
Neoplasms by Histologic Type Antineoplastic Agents Cisplatin Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 21, 2013