Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Uterine Neoplasms

Endometrial Neoplasms

Neoplasms, Glandular and Epithelial

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Neoplasms by Histologic Type

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Tubulin Modulators

Antimitotic Agents

Carboplatin AUC

Abraxane

Franco Muggia, MD

The purpose of this study is to evaluate the safety of treatment with carboplatin and Abraxane in this patient population and determine the nature and degree of toxicities following treatment. The single stage open label Phase II feasibility study is designed to estimate the proportion of patients who can tolerate the proposed regimen for 6 cycles with no more than two dose level reductions.

A Phase 2 Feasibility Study of Abraxane and Carboplatin in Epithelial Neoplasms of the Uterus

Tolerability for an individual patient will be defined as remaining on the study for 6 cycles with two or fewer dose reductions.

PFS is defined as the time from first dosing to the first observation of disease progression or death due to any cause. PFS was estimated beyond the collected data using Kaplan Meier methods.

ORR is the number of patients whose best tumor response outcome by Month 24 is a Complete Response (CR) or Partial Response (PR), divided by the total number of evaluable patients.

Per the Response Evaluation Criteria in Solid Tumors (RECIST v1.1.):

CR = Disappearance of all target lesions; PR = At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD

NYU Langone Health

Carboplatin AUC and Abraxane 100mg/m2

Approximately 23 patients will be enrolled in this study at the Laura \& Isaac Perlmutter Cancer Center at NYU Langone.There is a total of 17 study visits, including the screening visit to determine if you are eligible to participate. This study will be an out-patient study.

Age, Continuous

Female

Sex/Gender, Customized

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

1-MD Decision

1. Drug toxicity
2. progressive disease

Tolerability Measured Completion of Dose Regimen

Progression-Free Survival (PFS) at Month 24

Objective Response Rate (ORR) as Measured by RECIST 1.1 at Month 24

Overall Study

Symptoms and General Pathology

Recurrence

Camptothecin

Rubitecan

Dose: 0.4 mg/ml of 9-NC in aerosol reservoir for 60 minutes (= daily dose of 0.52 mg/m2/day) per day X5 every week, X8 weeks, then observe for 2 weeks. One course = 10 weeks (45-47).

9-NC in aerosol reservoir

Claire Verschraegen, MD

The purposes of this study are:

1.1 To determine the efficacy of liposomal 9-Nitro-20 (S)-Camptothecin (L9NC) administered by aerosolization to patients with metastatic endometrial cancer.

1.2 To determine toxicity profile of L9NC administered by aerosolization for 5 consecutive days per week X 8 weeks, every 10 weeks.

1.3 To perform a pharmacology study of L9NC in the plasma and the lungs after aerosolization. A specific protocol will be written for this part.

RATIONALE: Camptothecin (CPT) is a plant alkaloid isolated from Camptotheca acuminata in 1966. As a topoisomerase I inhibitor, it has powerful anticancer properties and has been used clinically in the treatment of a variety of cancers. It possesses significant toxicity, especially involving the bone marrow and gastrointestinal tract that has limited its use. Derivatives of 20-(S)-camptothecin have been made to increase the aqueous solubility of these compounds and/or modify the A-ring to increase membrane association. The 9-nitrocamptothecin (9-NC) derivative to be used in this study is insoluble in water, but has demonstrated potent antitumor effects in mice and antitumor effect in humans. However, the therapeutic index is low. In order to increase the therapeutic index, a liposomal formulation has been developed, which can be administered as an aerosol. In humans, dose of 0.52 mg/m2/day 5 days per weeks for eight 8 weeks of a 10 week course were well tolerated in the Phase I study. Partial responses were noted in patients with endometrial cancers. The recommended starting dose of L9NC in the Phase II study is 0.52 mg/m2/day to be administered once a day by aerosol (mouth-only breathing) for five consecutive days per week x 8 weeks followed by a 2 week rest. Courses are 10 weeks. This dose corresponds to approximately 1/6 of the MTD of oral 9-NC administered to untreated cancer patients.

Phase II Study of Aerosolized Liposomal 9-Nitro-20 (S)- Camptothecin (L9NC)

Phase II Study of Aerosolized Liposomal 9-Nitro-20 (S)- Camptothecin (L9NC) in Patients With Metastatic or Recurrent Cancer of the Endometrium

Baylor College of Medicine

University of New Mexico

Claire Verschraegen, MD; Principal Investigator

Harriet Smith, MD

The purpose of this study is to provide a repository for long-term storage of endometrial cancer tumor and normal tissue, ascites and serum. This material will be used in studies to better understand the molecular biology of endometrial cancer.

BACKGROUND AND RATIONALE

This protocol will create a central repository for banking tumor and other tissues as well as serum from patients with uterine corpus tumors. In addition, this protocol will also serve as a central repository for serum and tissue to healthy post-menopausal and peri-menopausal controls.

There will be an "internal" bank. The internal bank will have samples available to UNM investigators.

Tumor and normal tissues, ascites, and/or serum, and/or urine from women with malignant or premalignant gynecological conditions for which they are undergoing medically-indicated surgery, and normal tissues from women without malignancy who volunteer to donate serum and/or tissue at the time of medically indicated surgery

Pre-Clinical Models in Gynecological Tumors A Tissue Repository

Pre-Clinical Models in Gynecological Tumors: A Tissue Repository

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Disease Attributes

Topoisomerase I Inhibitors

Enzyme Inhibitors

Samples will be minced or centrifuged and L9NC extracted by chromatography. L9NC will be measured by HPLC or mass spectrometry

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

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.

Aerosolized Liposomal Camptothecin in Patients With Metastatic or Recurrent Cancer of the Endometrium or the Lung

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)

Claire Verschraegen, MD; Prinicpal Investigator

Carcinogenesis

Neoplastic Processes

Healthy postmenopausal and perimenopausal women with no history of endometrial carcinoma.

Women undergoing hysterectomy for benign conditions.

The purposes of this study are the following:

1. To further characterize and quantify both CSF-1 and colony-stimulating factor-1 receptor (CSF-1R) expression from additional tumor specimens, specifically, tumors of high grade and from metastatic sites.
2. To assay using Enzyme-Linked ImmunoSorbent Assay (ELISA) sandwich monoclonal antibody methodology, CSF-1 expression in the peritoneal fluid and blood from patients with endometrial adenocarcinomas.
3. Using immunohistochemistry, to evaluate the presence of staining for CSF-1 and CSF-1R from additional patients with endometrial adenocarcinomas, especially of high grades and from metastatic sites.
4. To determine the extent of cytokine, specifically CSF-1, but also interleukin-1 (IL-1), IL-6, and granulocyte-macrophage colony-stimulating factor (GM-CSF), production, in endometrial carcinoma cells in primary cell culture.
5. To determine the responsiveness of epithelial cells on estrogen and antiestrogen binding, to determine if CSF-1 production is mediated, in these cells, by estrogen receptor binding, or alternative pathways of intracellular/cell-cell signal transduction.
6. The ultimate objective of these experiments is to characterize CSF-1 expression from benign and tumor cells in order to identify steps in the CSF-1 activated signalling pathways that may represent potential targets for therapy.

These experiments, taken together, should critically determine if there is a role for the CSF-1/ c-fms autocrine, endocrine, or paracrine loop in the progression of endometrial adenocarcinoma. If so, alterations in this loop may provide novel medical therapies for this disease. Additionally, these experiments will determine which are the predominant cytokines expressed in these tumors, and will help the investigators to determine the role, if any, these cytokines play in cancer cell growth and proliferation in relationship with each other and within and outside of the estrogen-mediated pathways.

We have collected serum and ascites from approximately 200 patients with endometrial carcinoma and 200 controls. We have long term follow-up serum from approximately 60 of these patients. Approximately 10% of endometrial carcinoma patients recur. Our goal will be to eventually have follow-up serum from up to 60 patients with recurrent endometrial carcinoma in our tissue bank, so that we can determine the role of these assays in predicting recurrence.

Colony-Stimulating Factor-1 (CSF-1) and Other Cytokines in Human Endometrial Carcinogenesis

CSF-1 and Other Cytokines in Human Endometrial Carcinogenesis

Gland and Hormone Related Diseases

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Endocrine System Diseases

Gonadal Disorders

Ovarian Cancer

Ovarian Epithelial Cancer

Reproductive Control Agents

Hormones

Estrogens

Contraceptive Agents

Phytoestrogens

Contraceptives, Oral

Cases will be women with newly diagnosed endometrial or ovarian cancer who are residents of six counties in New Jersey.

Controls will be selected from the general population in those counties by use of random digit dialing for those under 65 years of age, from Centers for Medicare and Medicaid Services (CMS) lists for those aged 65 years and over, and from neighborhood sampling.

The main questionnaire will cover established risk and protective factors for endometrial and ovarian cancer, as well as other possible risk factors. This includes: menstrual history; pregnancy history; use of hormones for menopausal symptoms or other reasons; smoking history; height and weight; use of oral contraceptives and other methods of birth control; family history of cancer; medical history; demographic characteristics. We will also collect dietary data using the Gladys Block questionnaire, to which we have added a supplement to measure consumption of phytoestrogens. We will also obtain a buccal sample from each respondent as the source of DNA for genetic analysis.

Questionnaire

The main questionnaire will cover established risk and protective factors for endometrial and ovarian cancer, as well as other possible risk factors. This includes: menstrual history; pregnancy history; use of hormones for menopausal symptoms or other reasons; smoking history; height and weight; use of oral contraceptives and other methods of birth control; family history of cancer; medical history; demographic characteristics. We will also collect dietary data using the Gladys Block questionnaire, to which we have added a supplement to measure consumption of phytoestrogens. We will also obtain a buccal sample from each respondent as the source of DNA for genetic analysis.

We will conduct interviews mainly by telephone but also in person (at home or another convenient place)if the participant prefers.

Mengmeng Du, ScD

The purpose of this study is to see how people's diets, other aspects of their lifestyles, and their individual genetic makeup affect their chances of getting endometrial cancer (cancer of the uterus).

This survey will enroll several hundred women who have or have had endometrial cancer and several hundred who do not. We will compare these two groups of women to see what factors may lead to endometrial cancer.

We will conduct a population-based case-control study in six counties of New Jersey. Cases will be women with newly-diagnosed endometrial or ovarian cancer. Controls will be matched by 5-year age groups and selected by random digit dialing (for those under 65), from Centers for Medicare and Medicaid Services (CMS) files (for those 65 and over), or from neighborhood sampling. Controls will not have had a hysterectomy.

There will be 400 cases with endometrioid tumors, 60 with serous tumors or clear cell tumors, 300 with ovarian cancer, and 400 controls. In addition, there will be a small group of black women included from MSKCC.

We will interview participants about known and potential risk factors for endometrial and ovarian cancer and obtain information on diet. We will obtain DNA for genetic analysis from buccal specimens collected using a mouthwash rinse method. We will use logistic regression to determine odds ratios for disease with various exposures. For endometrial cancer, we will examine the association of risk with genotypes in strata defined by body mass index and dietary fat consumption.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase 2 Feasibility Study of Abraxane and Carboplatin in Epithelial Neoplasms of the Uterus	NCT02744898	Endometrial Can...	Carboplatin AUC Abraxane	18 Years -	NYU Langone Health
Phase II Study of Aerosolized Liposomal 9-Nitro-20 (S)- Camptothecin (L9NC)	NCT00249990	Corpus Uteri Endometrial Can...	9-NC in aerosol...	18 Years -	University of New Mexico
Pre-Clinical Models in Gynecological Tumors A Tissue Repository	NCT00250783	Endometrial Neo... Uterine Neoplas...		18 Years -	University of New Mexico
Aerosolized Liposomal Camptothecin in Patients With Metastatic or Recurrent Cancer of the Endometrium or the Lung	NCT00277082	Corpus Uteri Lung Cancer	9-NC in aerosol...	18 Years -	University of New Mexico
Phase II Study of Aerosolized Liposomal 9-Nitro-20 (S)- Camptothecin (L9NC)	NCT00249990	Corpus Uteri Endometrial Can...	9-NC in aerosol...	18 Years -	University of New Mexico
Colony-Stimulating Factor-1 (CSF-1) and Other Cytokines in Human Endometrial Carcinogenesis	NCT00250770	Uterine Neoplas... Endometrial Neo...		-	University of New Mexico
Colony-Stimulating Factor-1 (CSF-1) and Other Cytokines in Human Endometrial Carcinogenesis	NCT00250770	Uterine Neoplas... Endometrial Neo...		-	University of New Mexico
Estrogen, Diet, Genetics and Endometrial Cancer	NCT00587886	Cancer Endometrial Can... Ovarian Cancer Corpus Uteri Endometrium	Questionnaire Questionnaire	21 Years -	Memorial Sloan Kettering Cancer Center
A Phase 2 Feasibility Study of Abraxane and Carboplatin in Epithelial Neoplasms of the Uterus	NCT02744898	Endometrial Can...	Carboplatin AUC Abraxane	18 Years -	NYU Langone Health

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