NCT00277082

Aerosolized Liposomal Camptothecin in Patients With Metastatic or Recurrent Cancer of the Endometrium or the Lung

Pharmacology Study of Aerosolized Liposomal 9-Nitro-20 (S)- Camptothecin (L9NC) in Patients With Metastatic or Recurrent Cancer of the Endometrium or the Lung (NSCLC)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 24 (actual)
• Sponsor: University of New Mexico · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine the concentration of 9-nitrocamptothecin (9NC) in the alveolar fluid over time. 1.2. To determine the arterial concentration of 9NC administered by inhalation in comparison to venous and urine concentrations. 1.3. To determine the tumor concentration of 9NC administered by inhalation

Detailed description

TREATMENT PLAN (25-28) Patients will be admitted to the GCRC for 25 hours. Admission will be prior to the daily DLPC-9NC administration Upon admission, patients will be asked to empty their bladder. Urine will be collected for 24 hours, and refrigerated. Upon completion of the collection, urine will be mixed, and a 20 ml aliquot frozen and preserved for further analysis. A catheter will be placed in a peripheral vein, and in a peripheral artery, and appropriately heparinized. Venous and arterial blood samples (7 ml per samples) will be drawn in heparinized green tops prior to DLPC-9NC administration, and at the following time points: 2, 5, 8, 12, and 24 hours. An additional 2 samples may be drawn at the PI discretion. (Total blood drawn: 84 ml + 14 ml) During the GCRG hospitalization, a bronchoalveolar lavage (BAL) will be done according to standard practice once per patients. Patients will be divided in cohort of 6 (3 females and 3 males). Each cohort will undergo the BAL at a specific time point: within 30 minutes of the end of DLPC-9NC treatment, at 3 hours, 8 hours, and 24 hours. In responding patients that may become surgical candidate for a curative resection, one DLPC-9NC treatment will be administered prior to surgery (within 5 hours). Surgery will proceed as per standard of care and patients will sign a regular surgical consent for surgical procedure. Along with the tumor removal, one sample of venous blood and of arterial blood will be drawn for comparison (total volume: 14 ml). Once the tumor specimen is removed, a piece will be kept in liquid nitrogen, along with a piece of normal lung tissue, for further analysis. Patients will need to sign the attached consent form to authorize the collection of specimens.

Conditions

• Corpus Uteri
• Lung Cancer

Interventions

Type	Name	Description
DRUG	9-NC in aerosol reservoir	Samples will be minced or centrifuged and L9NC extracted by chromatography. L9NC will be measured by HPLC or mass spectrometry

Timeline

• Start date: 2003-08-01
• Completion: 2005-06-01
• First posted: 2006-01-13
• Last updated: 2010-01-07

Locations

1 site across 1 country: United States