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Study of Cytoreductive Surgery and Hyperthermic Intrathoracic Pleural Chemotherapy (HITC) With Escalating Doses for Children and Adolescents With Unilateral Pleural Malignancy

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ClinicalTrials.gov Identifier: NCT01998529
Recruitment Status : Recruiting
First Posted : November 29, 2013
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to find the highest tolerated dose of heated cisplatin that can be given to patients with lung tumors. The safety of this drug will also be studied.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: Cisplatin Drug: Amifostine Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Cytoreductive Surgery and Hyperthermic Intrathoracic Pleural Chemotherapy (HITC) With Escalating Doses for Children and Adolescents With Unilateral Pleural Malignancy
Actual Study Start Date : August 20, 2014
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Arm Intervention/treatment
Experimental: Cisplatin
After cytoreductive surgery, possible pneumonectomy, and possible diaphragm resection, the chest cavity will be closed in layers, leaving inflow and outflow chest tubes in place. Catheters connected to an extracorporeal perfusion circuit. Starting dose of hyperthermic cisplatin 120 mg/m2. Perfusion continued for 60 minutes after adding the cisplatin at a target temperature of 41 C (+0.5 C). In order to limit the systemic toxicity of cisplatin, amifostine administered intravenously over 15 minutes beginning 30 minutes after cisplatin perfusion. Patient response to amifostine continuously monitored by anesthesiologist. Infusion may be stopped and/or restarted based on blood pressure.
Drug: Cisplatin
Starting dose of hyperthermic cisplatin 120 mg/m2. Perfusion continued for 60 minutes after adding the cisplatin at a target temperature of 41 C (+0.5 C).
Other Names:
  • Platinol-AQ
  • Platinol
  • CDDP

Drug: Amifostine
Amifostine administered intravenously over 15 minutes beginning 30 minutes (+ 15 minutes) after the cisplatin perfusion.
Other Names:
  • Ethyol
  • Ethiofos
  • Gammaphos




Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) of Hyperthermic Intrathoracic Pleural Chemotherapy (HITC) [ Time Frame: Change in dose levels at 30 and 60 minutes after the infusion has started, and again 24 hours after receiving the heated cisplatin ]

    If 2 dose limiting toxicities (DLTs) are observed at a given dose level, MTD has been exceeded. Dose level below expanded to a total of 6 patients and if </= 1 out of 6 patients experience a DLT at this dose level, this will be defined as the MTD.

    Dose limiting toxicity may occur at any time during the initial hospitalization before discharge following the HITC. The dose limiting toxicity is defined two ways. Hematologic DLT is defined as Grade IV neutropenia, anemia, or thrombocytopenia. Non-hematologic DLT is any Grade III or IV non-hematologic toxicity excluding Grade III nausea or vomiting, Grade III hepatic toxicity which returns to Grade I within four weeks of the HITC, or before hospital discharge, or Grade III fever occurring after the HITC.



Secondary Outcome Measures :
  1. Time to Relapse [ Time Frame: 3 months ]
    Evaluation of measurable disease performed 3 months and 6 months postoperatively (+2 weeks) using CT and physical exam. Disease progression defined by radiographically visible nodules greater than 1.5 cm.



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Ages Eligible for Study:   3 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age >/= 3 years to </= 21 years.
  2. Histologically or genetically proven unilateral primary or metastatic active pleural malignancy.
  3. Radiologic workup must demonstrate that the thoracic disease is confined to only one hemi-thoracic cavity and must be deemed potentially resectable by the surgical team.
  4. The extrathoracic disease must be controlled.
  5. Patients must have a minimum expected duration of survival of 8 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.
  7. Patients must have Adequate Renal Function Defined as: Creatinine clearance or radioisotope GFR >/=70ml/min/1.73 m^2 or a serum creatinine based on age/gender less than listed value in the table below: 1 to < 2 years 0.6 mg/dL for both males and females, 2 to < 6 years 0.8 mg/dL for both males and females, 6 to < 10 years 1 mg/dL for both males and females, 10 to < 13 years 1.2 mg/dL for both males and females, 13 to < 16 years 1.5 mg/dL for males and 1.4 mg/dL for females, >/= 16 years 1.7 for males and 1.4 for females
  8. Patients will be eligible if the WBC is >/=1500/µl or ANC is >/=1,000 and platelets are >/= 50,000/mm^3
  9. Adequate Liver Function Defined as: -Bilirubin (sum of conjugated + unconjugated) </= 1.5 x upper limit of normal (ULN) for age -SGPT (ALT) </=110 U/L. For the purpose of this study, the ULN for SGPT is 45 U/L. -Serum albumin >/= 2 g/dL.
  10. 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 who have failed previous hemi-thoracic platinum therapy will be ineligible ("Failed" is having disease recurrence </= 3 months).
  3. No pregnant or lactating females.
  4. Patients will be ineligible if they have a lymphoma diagnosis.

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): NCT01998529


Contacts
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Contact: Andrea Hayes-Jordan, MD 713-794-4616

Locations
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United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Andrea Hayes-Jordan, MD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01998529     History of Changes
Other Study ID Numbers: 2012-0657
NCI-2014-00510 ( Registry Identifier: NCI CTRP )
First Posted: November 29, 2013    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018

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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:
Lung Cancer
Unilateral Pleural Malignancy
Metastatic active pleural malignancy
Lung tumors
Sarcomas
Cytoreductive Surgery
Hyperthermic Intrathoracic Pleural Chemotherapy
HITC
Cisplatin
Platinol-AQ
Platinol
CDDP
Amifostine
Ethyol
Ethiofos
Gammaphos

Additional relevant MeSH terms:
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Neoplasms
Fever
Body Temperature Changes
Signs and Symptoms
Cisplatin
Amifostine
Antineoplastic Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs