Overview

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

Status:
Active, not recruiting

Trial end date:
2020-09-30

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

M.D. Anderson Cancer Center

Treatments:

Amifostine
Cisplatin

Criteria

Inclusion Criteria:

1. Age >/= 3 years to
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) 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. No pregnant or lactating females.

4. Patients will be ineligible if they have a lymphoma diagnosis.