Aerosolized Liposomal Camptothecin in Patients With Metastatic or Recurrent Cancer of the Endometrium or the Lung
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|ClinicalTrials.gov Identifier: NCT00277082|
Recruitment Status : Completed
First Posted : January 13, 2006
Last Update Posted : January 7, 2010
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
|Condition or disease||Intervention/treatment|
|Corpus Uteri Lung Cancer||Drug: 9-NC in aerosol reservoir|
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.
|Study Type :||Observational|
|Actual Enrollment :||24 participants|
|Official Title:||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)|
|Study Start Date :||August 2003|
|Actual Study Completion Date :||June 2005|
- 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 spectrometryOther Name: Liposomal-Nitro-20 (S)-Camptothecin
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00277082
|United States, New Mexico|
|University of New Mexico|
|Albuquerque, New Mexico, United States, 87131|
|Principal Investigator:||Claire Verschraegen, MD||University of New Mexico|