Study of Cytoreductive Surgery and Hyperthermic Intrathoracic Pleural Chemotherapy (HITC) With Es… (NCT01998529) | Clinical Trial Compass
CompletedPhase 1
Study of Cytoreductive Surgery and Hyperthermic Intrathoracic Pleural Chemotherapy (HITC) With Escalating Doses for Children and Adolescents With Unilateral Pleural Malignancy
United States7 participantsStarted 2014-08-20
Plain-language 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.
Who can participate
Age range3 Years – 21 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
✕. Patients will be ineligible if they have any concomitant cardiopulmonary disease which would place them at unacceptable risk for a major surgical procedure
What they're measuring
1
Maximum Tolerated Dose (MTD) of Hyperthermic Intrathoracic Pleural Chemotherapy (HITC)
Timeframe: Change in dose levels at 30 and 60 minutes after the infusion has started, and again 24 hours after receiving the heated cisplatin