Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01277744
Recruitment Status : Completed
First Posted : January 17, 2011
Results First Posted : October 1, 2019
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Advanced Cancers Sarcoma Procedure: Hyperthermic Peritoneal Perfusion (HIPEC) Drug: Cisplatin Phase 2

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : May 9, 2011
Actual Primary Completion Date : February 16, 2018
Actual Study Completion Date : February 16, 2018


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: From the date of diagnosis to the date of death or last follow up date for patient alive. ]
    From the date of diagnosis to the date of death or last follow up date for patient alive.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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 white blood cell count (WBC) is >/=2000/microliter or absolute neutrophil count (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.

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): NCT01277744


Locations
Layout table for location information
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Layout table for investigator information
Principal Investigator: Andrea Hayes-Jordan, MD M.D. Anderson Cancer Center
  Study Documents (Full-Text)

Documents provided by M.D. Anderson Cancer Center:

Additional Information:
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01277744     History of Changes
Other Study ID Numbers: 2009-0528
NCI-2011-00245 ( Registry Identifier: NCI CTRP )
First Posted: January 17, 2011    Key Record Dates
Results First Posted: October 1, 2019
Last Update Posted: October 1, 2019
Last Verified: September 2019

Layout table for additional information
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:
Hyperthermic peritoneal perfusion
Desmoplastic small round cell tumor
DSRCT
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:
Layout table for MeSH terms
Desmoplastic Small Round Cell Tumor
Fever
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Body Temperature Changes
Signs and Symptoms
Cisplatin
Antineoplastic Agents