Heated Chemotherapy for Cancers That Have Spread to the Chest Cavity

St. Luke's-Roosevelt Hospital Center

Status and phase: Completed; Phase 2

Conditions: Breast Cancer; Uterine Cancer; Colon Cancer; Pleural Metastases; Thymic Cancer; Renal Cell Cancer; Ovarian Cancer

Treatments: Procedure: Surgical debulking and Intrathoracic Hyperthermic Chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01163552

SLR IRB#09-207

Details and patient eligibility

About

Cancers that have spread to the inner lining of the chest are classified as Stage IV and bear a poor prognosis. Surgery is rarely an option, with palliative chemotherapy and/or radiation therapy the only treatment options. This study intends to evaluate whether surgical removal of all visible tumor on the chest wall followed by bathing the chest cavity in heated chemotherapy solution will improve outcomes for these advanced cancers.

Enrollment: 5 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adults aged 18-75 years
2. Radiographic evidence of pleural dissemination with histologically or cytologically confirmed diagnosis.
3. Primary source control (breast, ovarian, uterine, colon, renal cell, thymic cancer)
4. Adequate liver and renal function defined as a bilirubin of < 2.0 mg/dl, albumin > 3.0g/dl, and a creatinine of < 1.5 mg/dl, respectively.
5. Absolute neutrophil count (ANC) of ≥1,500/mm3 and a platelet count ≥100,000/mm3.
6. A Karnofsky Performance Status score of ≥60

Exclusion criteria

1. Patients without satisfactory oncological control of their primary cancer.

2. Radiographic evidence of abdominal, pelvic, or intracranial metastatic disease.

3. Chemotherapy and/or radiotherapy must have been completed at least one month prior to entry in the study. Patients may not receive concurrent chemotherapy, immunotherapy, radiotherapy, or any investigational drugs while participating in this study.

4. Significant active medical disease including, but not limited to:

   • Cardiac disease, including: congestive heart failure or angina pectoris; recent (within 1 year) history of a myocardial infarction; uncontrolled hypertension; arrhythmias.
   • Active infections
   • Uncontrolled diabetes mellitus
   • Chronic renal insufficiency
   • HIV/AIDS - routine HIV testing will not be performed, but patients known to be HIV positive will be excluded.

5. Pregnant or lactating women.

6. Allergy to intravenous contrast

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

5 participants in 1 patient group

Surgical Debulking and Intrathoracic Hyperthermic Chemotherapy

Experimental group

Description:

Patients in this trial will undergo surgical debulking followed by intrathoracic hyperthermic chemotherapy perfusion.

Treatment:

Procedure: Surgical debulking and Intrathoracic Hyperthermic Chemotherapy