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

NCT01277744 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 2009-0528NCI-2011-00245
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

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; Cisplatin; Platinol-AQ; Platinol; CDDP; Diffuse peritoneal tumor; Retroperitoneal tumor; Ovarian germ cell; Wilms' tumor

Outcome Measures

Primary Outcomes (1)

• 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

  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 up to 81 months

Study Arms (1)

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.

Procedure: Hyperthermic Peritoneal Perfusion (HIPEC); Drug: Cisplatin

Interventions

Hyperthermic Peritoneal Perfusion (HIPEC) PROCEDURE

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.

HIPEC + Cisplatin

Cisplatin DRUG

100 mg/M2 per perfusion catheter. The perfusion is continued for 90 minutes after adding the cisplatin.

Also known as: Platinol-AQ, Platinol, CDDP

HIPEC + Cisplatin

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Sarcoma; Desmoplastic Small Round Cell Tumor; Wilms Tumor

Interventions

Hyperthermic Intraperitoneal Chemotherapy; Cisplatin

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Complex and Mixed; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplastic Syndromes, Hereditary; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Chemotherapy, Adjuvant; Combined Modality Therapy; Therapeutics; Drug Therapy; Hyperthermia, Induced; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Results Point of Contact

• Title: Andrea Hayes-Jordan M.D. / Surgical Oncology
• Organization: UT MD Anderson Cancer Center

AHJORDAN@MDANDERSON.ORG

713-794-4616

Study Officials

• Andrea Hayes-Jordan, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2011
• First Posted: January 17, 2011
• Study Start: May 9, 2011
• Primary Completion: February 16, 2018
• Study Completion: February 16, 2018
• Last Updated: January 13, 2020
• Results First Posted: October 1, 2019

Record last verified: 2020-01

Locations

US (1)