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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)


N/A
18 Years
N/A
Not Enrolling
Both
Corpus Uteri, Lung Cancer

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Trial Information

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
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.


For Endometrial:

Inclusion Criteria:



- 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 are eligible.

- Patients must have a life expectancy of at least 12 weeks.

- Patients much have a Zubrod performance status of 0-2.

- Patients must sign an informed consent.

- Patients should have adequate bone marrow function defined by an absolute peripheral
granulocyte count of >= 1,500 or cells/mm³ and platelet count > 100,000/mm³ and
absence of a regular red blood cell transfusion requirement.

- Patients should have adequate hepatic function with a total bilirubin < 2 mg/dl and
SGOT or SGPT < two times the upper limit of normal, and adequate renal function as
defined by a serum creatinine <= 1.5 x upper limit of normal.

- Patients must not have a known symptomatic respiratory disease other than cancer, and
must have a pulmonary function test equal to >= 50% FEV1, >= 50% FEV1/FVC, >= 50%
TLC, and >= 50% DLCO of predicted values.

Exclusion Criteria:

- Patients with symptomatic brain metastases are excluded from this study.

- Pregnant women or nursing mothers are not eligible for this trial. Patients of child
bearing potential must use adequate contraception.

- Patients may receive no other concurrent chemotherapy or radiation therapy during
this trial.

- Patients with severe medical problems such as uncontrolled diabetes mellitus or
cardiovascular disease or active infections are not eligible for this trial.

- Any criteria that is borderline and may lead to ineligibility will be reviewed by the
PI, who may override the eligibility criteria, after receiving sponsor agreement, if
entry into the study is deemed to potentially benefit the patient.

For Lung:

Inclusion Criteria:



- All patients, 18 years of age or older, with stage 3b, 4, or recurrent,
nonresectable, non-small-cell lung carcinoma are eligible.

- Patients must have a life expectancy of at least 12 weeks.

- Patients must have a Zubrod performance status of 0-2.

- Patients must sign an informed consent.

- Patients should have adequate hepatic function with a total bilirubin < 2 mg/dl and
SGOT or SGPT < two times the upper limit of normal, and adequate renal function as
defined by a serum creatinine <= 1.5 x upper limit of normal.

- Patients must not have a known symptomatic respiratory disease other than cancer, and
must have a pulmonary function test equal to >= 50% FEV1, >= 50% FEV1/FVC, >= 50%
TLC, and >= 50% DLCO of predicted values.

Exclusion Criteria:

- Patients with symptomatic brain metastases are excluded from this study.

- Pregnant women or nursing mothers are not eligible for this trial. Patients of child
bearing potential must use adequate contraception.

- Patients may receive no other concurrent chemotherapy or radiation therapy during
this trial.

- Patients with severe medical problems such as uncontrolled diabetes mellitus or
cardiovascular disease or active infections are not eligible for this trial.

- Any criteria that is borderline and may lead to ineligibility will be reviewed by the
PI, who may override the eligibility criteria, after receiving sponsor agreement, if
entry into the study is deemed to potentially benefit the patient.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Principal Investigator

Claire Verschraegen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of New Mexico

Authority:

United States: Institutional Review Board

Study ID:

1302C

NCT ID:

NCT00277082

Start Date:

August 2003

Completion Date:

June 2005

Related Keywords:

  • Corpus Uteri
  • Lung Cancer
  • Metastatic or Recurrent Cancer of the Endometrium or the Lung (NSCLC)
  • Aerosolized Liposomal 9-Nitro 20
  • Camptothecin (L9NC)
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Lung Neoplasms
  • Recurrence

Name

Location

University of New MexicoAlbuquerque, New Mexico  87131