CompletedPhase 1NCT01998529
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedCisplatin and Amifostine

The study team can explain what participation involves.

Who it may be forLung Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 14, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?M.D. Anderson Cancer Center

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
M.D. Anderson Cancer Center
Interventions being studied
Drug: Cisplatin; Drug: Amifostine
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of Texas MD Anderson Cancer CenterHouston, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 14, 2023. Always confirm current availability with the study team.

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