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)
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
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.
Observational Model: Cohort, Time Perspective: Prospective
Claire Verschraegen, MD
University of New Mexico
United States: Institutional Review Board
|University of New Mexico||Albuquerque, New Mexico 87131|