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

NCT01998529 | Completed Phase 1 FDA Drug

• 2 other identifiers: 2012-0657NCI-2014-00510
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD) of Hyperthermic Intrathoracic Pleural Chemotherapy (HITC)

  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.

  Change in dose levels at 30 and 60 minutes after the infusion has started, and again 24 hours after receiving the heated cisplatin

Secondary Outcomes (1)

• Time to Relapse

  3 months

Study Arms (1)

Cisplatin

EXPERIMENTAL

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; Drug: Amifostine

Interventions

Cisplatin DRUG

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).

Also known as: Platinol-AQ, Platinol, CDDP

Cisplatin

Amifostine DRUG

Amifostine administered intravenously over 15 minutes beginning 30 minutes (+ 15 minutes) after the cisplatin perfusion.

Also known as: Ethyol, Ethiofos, Gammaphos

Cisplatin

Eligibility Criteria

• Age: 3 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age \>/= 3 years to \</= 21 years.
• Histologically or genetically proven unilateral primary or metastatic active pleural malignancy.
• 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.
• The extrathoracic disease must be controlled.
• Patients must have a minimum expected duration of survival of 8 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.
• 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
• Patients will be eligible if the WBC is \>/=1500/µl or ANC is \>/=1,000 and platelets are \>/= 50,000/mm\^3
• 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.
• 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 who have failed previous hemi-thoracic platinum therapy will be ineligible ("Failed" is having disease recurrence \</= 3 months).
• No pregnant or lactating females.
• Patients will be ineligible if they have a lymphoma diagnosis.

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

Lung Neoplasms; Sarcoma

Interventions

Cisplatin; Amifostine

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Organothiophosphates; Organophosphates; Organophosphorus Compounds; Organic Chemicals; Organothiophosphorus Compounds; Sulfur Compounds

Study Officials

• David Rice, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2013
• First Posted: November 29, 2013
• Study Start: August 20, 2014
• Primary Completion: August 25, 2020
• Study Completion: August 25, 2020
• Last Updated: September 14, 2023

Record last verified: 2023-09

Locations

US (1)