Clinical trial · Interventional
Study of Cytoreductive Surgery and Hyperthermic Intrathoracic Pleural Chemotherapy (HITC) With Escalating Doses for Children and Adolescents With Unilateral Pleural Malignancy
A Phase I Study of Cytoreductive Surgery and Hyperthermic Intrathoracic Pleural Chemotherapy (HITC) With Escalating Doses for Children and Adolescents With Unilateral Pleural Malignancy
NCT01998529CI-TRIAL-00069618completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Amifostine | Drug | — | UNRESOLVED |
| Cisplatin | Drug | Cisplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cisplatin
- description
- 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.
- interventionNames
- Drug: Cisplatin
- Drug: Amifostine
Primary outcomes (1)
- measure
- 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
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 21 Years
Show eligibility criteria text
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.References
Publications (0)
Data not yet available
No reference posted for this study.