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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
Sponsor:
Information provided by:
University of New Mexico

Brief 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


Condition or disease Intervention/treatment
Corpus Uteri Lung Cancer Drug: 9-NC in aerosol reservoir

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.


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Study Type : Observational
Actual Enrollment : 24 participants
Observational Model: Cohort
Time Perspective: 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)
Study Start Date : August 2003
Actual Study Completion Date : June 2005

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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
    Other Name: Liposomal-Nitro-20 (S)-Camptothecin


Biospecimen Retention:   Samples Without DNA
Blood, lung tissue, lung cancer tissue.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.
Criteria

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.

Information from the National Library of Medicine

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


Locations
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United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
University of New Mexico
Investigators
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Principal Investigator: Claire Verschraegen, MD University of New Mexico

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Responsible Party: Claire Verschraegen, MD; Prinicpal Investigator, University of New Mexico - CRTC
ClinicalTrials.gov Identifier: NCT00277082     History of Changes
Other Study ID Numbers: 1302C
First Posted: January 13, 2006    Key Record Dates
Last Update Posted: January 7, 2010
Last Verified: April 2008

Keywords provided by University of New Mexico:
Metastatic or Recurrent Cancer of the Endometrium or the Lung (NSCLC)
Aerosolized Liposomal 9-Nitro 20
Camptothecin (L9NC)

Additional relevant MeSH terms:
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Recurrence
Endometrial Neoplasms
Disease Attributes
Pathologic Processes
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Camptothecin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action