Pilot Study of Hyperthermic Peritoneal Perfusion (HIPEC) for Adolescent and Young Adults With Desmoplastic Small Round Cell Tumor

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01277744
First received: January 12, 2011
Last updated: January 23, 2014
Last verified: January 2014
  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: 22
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:
  • Platinol-AQ
  • Platinol
  • CDDP

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age greater than or equal to 1 years
  2. 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.
  3. Radiologic workup must demonstrate that the disease is confined to the abdominal cavity
  4. 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
  5. 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.
  6. 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.
  7. 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.
  8. 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)
  9. Patients will be eligible if the WBC is >/=2000/microliter or ANC is >/=1,500 and platelets are >/= 100,000/mm^3
  10. Patients will be eligible if serum total bilirubin and liver enzymes are </=2 times the upper limit of normal
  11. 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
  3. Patients will be ineligible if they have a baseline neurologic toxicity of Grade 3 or greater (because of the potential neurotoxicity associated with platinum)
  4. Patients who have failed previous intraperitoneal platinum therapy will be ineligible
  5. Patients with Retroperitoneal Liposarcoma will be ineligible.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01277744

Locations
United States, Texas
UT MD Anderson Cancer Center
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: January 23, 2014
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
Body Temperature Changes
Signs and Symptoms
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 18, 2014