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Sponsored by: |
University of New Mexico |
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Information provided by: | University of New Mexico |
ClinicalTrials.gov Identifier: | NCT00277082 |
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 | Intervention |
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Corpus Uteri Lung Cancer |
Drug: 9-NC in aerosol reservoir |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
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) |
Blood, lung tissue, lung cancer tissue.
Enrollment: | 24 |
Study Start Date: | August 2003 |
Study Completion Date: | June 2005 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
All patients, 18 years of age or older, with metastatic and/or recurrent endometrial cancer or with mixed mesenchymal malignant tumors whose epithelial component is recurring, who have failed standard chemotherapy or hormonal regimens for their disease or who refuse recommended standard chemotherapy.
For Endometrial:
Inclusion Criteria:
Exclusion Criteria:
For Lung:
Inclusion Criteria:
Exclusion Criteria:
United States, New Mexico | |
University of New Mexico | |
Albuquerque, New Mexico, United States, 87131 |
Principal Investigator: | Claire Verschraegen, MD | University of New Mexico |
Responsible Party: | University of New Mexico - CRTC ( Claire Verschraegen, MD; Prinicpal Investigator ) |
Study ID Numbers: | 1302C |
Study First Received: | January 12, 2006 |
Last Updated: | May 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00277082 History of Changes |
Health Authority: | United States: Institutional Review Board |
Metastatic or Recurrent Cancer of the Endometrium or the Lung (NSCLC) Aerosolized Liposomal 9-Nitro 20 Camptothecin (L9NC) |
Thoracic Neoplasms Genital Neoplasms, Female Uterine Diseases Urogenital Neoplasms Endometrial Cancer 9-nitrocamptothecin Camptothecin Recurrence |
Genital Diseases, Female Endometrial Neoplasms Respiratory Tract Diseases Lung Neoplasms Lung Diseases Uterine Neoplasms Non-small Cell Lung Cancer Antineoplastic Agents, Phytogenic |
Thoracic Neoplasms Respiratory Tract Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Genital Neoplasms, Female Uterine Diseases Enzyme Inhibitors Urogenital Neoplasms 9-nitrocamptothecin Pharmacologic Actions Camptothecin |
Genital Diseases, Female Endometrial Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Uterine Neoplasms Antineoplastic Agents, Phytogenic |