Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Blood and Lymph Conditions

Immune System Diseases

Substance Related Disorders

Skin and Connective Tissue Diseases

Rare Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Adenocarcinoma

Stomach Neoplasms

Pancreatic Neoplasms

Recurrence

Carcinoma, Ovarian Epithelial

Cholangiocarcinoma

Lymphoma

Hypoxia

Gastrointestinal Stromal Tumors

Liver Neoplasms

Sarcoma

Carcinoid Tumor

Leiomyosarcoma

Rectal Neoplasms

Colonic Neoplasms

Neoplasms, Germ Cell and Embryonal

Fallopian Tube Neoplasms

Gallbladder Neoplasms

Germinoma

Ovarian Neoplasms

Bile Duct Neoplasms

Syndrome

Malignant Carcinoid Syndrome

Serotonin Syndrome

Gastrointestinal Neoplasms

Digestive System Neoplasms

Intestinal Neoplasms

Disease Attributes

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Neoplasms, Connective and Soft Tissue

Stomach Diseases

Colorectal Neoplasms

Intestinal Diseases

Rectal Diseases

Colonic Diseases

Liver Diseases

Genital Neoplasms, Female

Urogenital Neoplasms

Fallopian Tube Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Ovarian Diseases

Gonadal Disorders

Neoplasms, Connective Tissue

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Nerve Tissue

Biliary Tract Neoplasms

Biliary Tract Diseases

Gallbladder Diseases

Bile Duct Diseases

Stomach Cancer

Pancreatic Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Bile Duct Cancer

Lymphosarcoma

Primary Liver Cancer

Gallbladder Cancer

Soft Tissue Sarcoma

Germ Cells Tumors

Fallopian Tube Cancer

Small Intestinal Adenocarcinoma

Ovarian Germ Cell Tumor

Uterine Sarcoma

Small Intestine Cancer

Central Nervous System Germinoma

Carcinoid Syndrome

Neuroendocrine Tumor

Neuroepithelioma

Dermatologic Agents

All Drugs and Chemicals

Antineoplastic Agents

Photosensitizing Agents

Etanidazole

Motexafin lutetium

Patients receive EF5 IV over 1-2.5 hours on day 1 and motexafin lutetium IV over 10-15 minutes on day 2. Patients undergo definitive surgical resection approximately 3 hours after motexafin lutetium administration. Hypoxia and motexafin lutetium levels in the resected tumors are evaluated. Tumor to normal tissue ratios are also determined.

motexafin lutetium

pharmacological study

Stephen Michael Hahn

This clinical trial is studying the amount of EF5 and motexafin lutetium present in tumor cells and/or normal tissues of patients with abdominal (such as ovarian, colon, or stomach cancer) or non-small cell lung cancer. EF5 may be effective in measuring oxygen in tumor tissue. Photosensitizing drugs such as motexafin lutetium are absorbed by tumor cells and, when exposed to light, become active and kill the tumor cells. Knowing the level of oxygen in tumor tissue and the level of motexafin lutetium absorbed by tumors and normal tissue may help predict the effectiveness of anticancer therapy

OBJECTIVES:

I. Determine the uptake of motexafin lutetium in tumors and normal tissue of patients with intra-abdominal malignancies or non-small cell lung cancer.

II. Determine the ratio of tumor to normal tissue by measuring the level of motexafin lutetium uptake in tumor and normal tissue removed from these patients.

III. Determine the pattern, presence, and level of EF5 binding (as a surrogate marker for hypoxia) in tumors of these patients.

IV. Determine the feasibility of measuring optical properties, tissue oxygenation, motexafin lutetium concentration, fluorescence, and blood flow by non-invasive means in these patients.

OUTLINE: This is a multicenter, diagnostic study. Patients are stratified according to diagnosis (intra-abdominal malignancy vs non-small cell lung cancer).

Patients receive EF5 IV over 1-2.5 hours on day 1 and motexafin lutetium IV over 10-15 minutes on day 2. Patients undergo definitive surgical resection approximately 3 hours after motexafin lutetium administration. Hypoxia and motexafin lutetium levels in the resected tumors are evaluated. Tumor to normal tissue ratios are also determined.

After completion of study treatment, patients are followed at approximately 1-8 weeks.

PROJECTED ACCRUAL: A total of 30 patients (20 with intra-abdominal malignancies and 10 with non-small cell lung cancer) will be accrued for this study within 10-15 months.

EF5 and Motexafin Lutetium in Detecting Tumor Cells in Patients With Abdominal or Non-Small Cell Lung Cancer

Distribution Of The Photosensitizer Motexafin Lutetium And Hypoxia In Patients With Malignancies

Data will be described using graphical techniques (e.g., box plots) and summary statistics (e.g., means, medians, standard deviations, and interquartile ranges). For each patient, the mean concentration of motexafin lutetium across tumor and normal samples will be summarized.

Summary data for each patient will be used to construct a TNTR. Wilcoxon signed rank test of whether the median ration exceeds will be carried out.

Will be graded, tabled for each stratum and for the entire study and summarized by frequencies and percentages.

National Cancer Institute (NCI)

Uterine Cervical Neoplasms

Carcinoma in Situ

Uterine Cervical Dysplasia

Uterine Cervical Diseases

Uterine Diseases

Precancerous Conditions

Cervical Intraepithelial Neoplasia

Patients receive lutetium texaphyrin IV over 5-20 minutes. Patients undergo in vivo tissue assessment by spectrometer at 0, 1, 3, 5, 12, and 24 hours and loop electrical excision procedure (LEEP) at 24 hours after lutetium texaphyrin infusion.

Patients receive lutetium texaphyrin IV over 5-20 minutes. A laser delivers 730 nm of light to the cervix for 4, 8, or 16 minutes. Patients undergo LEEP at 4, 8, or 12 hours after exposure of the cervix to the light source.

photodynamic therapy

loop electrosurgical excision procedure

laboratory biomarker analysis

John Comerci

Phase I trial to study the effectiveness of photodynamic therapy with lutetium texaphyrin in treating patients who have cervical intraepithelial neoplasia. Photodynamic therapy uses light and drugs such as lutetium texaphyrin that make abnormal cells more sensitive to light and may kill abnormal cells in the cervix and prevent the development of cervical cancer

OBJECTIVES:

I. Determine the optimal dosage with the least toxicity of lutetium texaphyrin as well as the length of time following its systemic injection that provides the maximum differential in drug uptake between the target dysplastic squamous cells and normal squamous epithelium when given to patients with cervical intraepithelial neoplasia (CIN).

II. Determine, by histomorphometry, the photodynamic light dose that demonstrates the greatest treatment selectivity between normal cervical epithelium and CIN with the least amount of cervical pain and necrosis.

OUTLINE: This is a dose-escalation study of lutetium texaphyrin (part 1) followed by a dose-escalation study of light fluence (part 2).

Part 1: Patients receive lutetium texaphyrin IV over 5-20 minutes. Patients undergo in vivo tissue assessment by spectrometer at 0, 1, 3, 5, 12, and 24 hours and loop electrical excision procedure (LEEP) at 24 hours after lutetium texaphyrin infusion.

Part 2: Patients receive lutetium texaphyrin IV over 5-20 minutes. A laser delivers 730 nm of light to the cervix for 4, 8, or 16 minutes. Patients undergo LEEP at 4, 8, or 12 hours after exposure of the cervix to the light source.

Cohorts of 9 patients receive escalating doses of lutetium texaphyrin (part 1) and then light fluence (part 2) until the maximum tolerated dose (MTD) of each is determined. The MTD is defined as the dose preceding that at which 2 of 9 patients experience dose-limiting toxicity.

Patients are followed at 48 hours, weekly for 1 month, and then at 4 months.

PROJECTED ACCRUAL: A maximum of 54 patients will be accrued for this study.

Photodynamic Therapy Using Lutetium Texaphyrin in Treating Patients With Cervical Intraepithelial Neoplasia

Phase I Study Photodynamic Therapy Using Lutrin (Lutetium Texaphyrin) in the Treatment of Patients With Cervical Intraepithelial Neoplasia

A simplified graphical analysis will be utilized to determine the drug dose and time after administration that provides the largest differential area between lutein texaphyrin tissue levels in neoplastic and normal cervical tissue

A simplified graphical analysis will be utilized to determine the fluence that provides the maximal differential area between neoplastic and normal cervical epithelium and stroma.

Prostatic Neoplasms

Genital Neoplasms, Male

Genital Diseases, Male

Prostatic Diseases

Male Urogenital Diseases

Patients receive lutetium texaphyrin IV over 10-15 minutes 3-24 hours before photodynamic therapy (PDT). Optical fibers attached to a laser are inserted through a catheter into the prostate. The laser delivers 730 nm light to the prostate until the specified fluence is delivered. Patients undergo biopsy of the prostate and bladder before and after PDT. Cohorts of 3-6 patients receive escalating doses of lutetium texaphyrin and light fluence until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.

This phase I trial is studying the side effects and best dose of photodynamic therapy with lutetium texaphyrin in treating patients with locally recurrent prostate cancer. Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. This may be effective treatment for locally recurrent prostate cancer. Photosensitizing drugs, such as lutetium texaphyrin, are absorbed by cancer cells and, when exposed to light, become active and kill the cancer cells

PRIMARY OBJECTIVES:

I. Determine the dose limiting toxicities and maximum tolerated dose of photodynamic therapy (PDT) using 730 nm light and lutetium texaphyrin in patients with locally recurrent prostate adenocarcinoma who have failed previous definitive radiotherapy.

SECONDARY OBJECTIVES:

I. Measure lutetium texaphyrin levels in needle biopsies of the prostate before and after PDT using an HPLC and tissue fluorescence assay and calculate the percent change in lutetium texaphyrin after treatment.

II. Measure lutetium texaphyrin fluorescence in situ in the prostate before and after PDT using optical methods and correlate these results with the direct tissue measurements made in the biopsies of these patients.

III. Determine clinical outcome including clinical response, progression free survival, time to complete response, time to biochemical relapse, time to local progression, time to distant failure, overall survival, and disease specific survival in these patients treated with this regimen.

OUTLINE: This is a dose-escalation study of lutetium texaphyrin and light fluence.

Patients receive lutetium texaphyrin IV over 10-15 minutes 3-24 hours before photodynamic therapy (PDT). Optical fibers attached to a laser are inserted through a catheter into the prostate. The laser delivers 730 nm light to the prostate until the specified fluence is delivered. Patients undergo biopsy of the prostate and bladder before and after PDT. Cohorts of 3-6 patients receive escalating doses of lutetium texaphyrin and light fluence until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.

Patients are followed at 2 weeks, 1 month, 2 months, 3 months, then every 3 months until 2 years, then every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A minimum of 24 patients will be accrued for this study within 3 years.

Photodynamic Therapy With Lutetium Texaphyrin in Treating Patients With Locally Recurrent Prostate Cancer

A Phase I Trial of Photodynamic Therapy With Lutetium Texaphyrin in Patients With Locally Recurrent Prostate Carcinoma

Scattergrams and error bar plots of lutetium texaphyrin concentration by lutetium texaphyrin dose level and possibly by light fluence (for a fixed lutetium texaphyrin dose = 2) will be constructed to investigate possible dose-concentration relationships.

Descriptive statistics (mean, median, standard deviation, range and coefficient of variation) will be used to characterize the distribution of lutetium texaphyrin concentrations within each dose level.

The 95% confidence interval will be calculated for the rate of NED.

Estimated by the method of Kaplan and Meier.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
EF5 and Motexafin Lutetium in Detecting Tumor Cells in Patients With Abdominal or Non-Small Cell Lung Cancer	NCT00087191	Advanced Adult ... Carcinoma of th... Fallopian Tube ... Gastrointestina... Localized Extra... Localized Gallb... Localized Gastr... Localized Resec... Localized Unres... Metastatic Gast... Ovarian Sarcoma Ovarian Stromal... Primary Periton... Recurrent Adult... Recurrent Adult... Recurrent Colon... Recurrent Extra... Recurrent Gallb... Recurrent Gastr... Recurrent Gastr... Recurrent Non-s... Recurrent Ovari... Recurrent Ovari... Recurrent Pancr... Recurrent Recta... Recurrent Small... Recurrent Uteri... Regional Gastro... Small Intestine... Small Intestine... Small Intestine... Stage 0 Non-sma... Stage I Adult S... Stage I Colon C... Stage I Gastric... Stage I Non-sma... Stage I Ovarian... Stage I Ovarian... Stage I Pancrea... Stage I Rectal ... Stage I Uterine... Stage II Adult ... Stage II Colon ... Stage II Gastri... Stage II Non-sm... Stage II Ovaria... Stage II Ovaria... Stage II Pancre... Stage II Rectal... Stage II Uterin... Stage III Adult... Stage III Colon... Stage III Gastr... Stage III Ovari... Stage III Ovari... Stage III Pancr... Stage III Recta... Stage III Uteri... Stage IIIA Non-... Stage IIIB Non-... Stage IV Adult ... Stage IV Colon ... Stage IV Gastri... Stage IV Non-sm... Stage IV Ovaria... Stage IV Ovaria... Stage IV Pancre... Stage IV Rectal... Stage IV Uterin... Unresectable Ex... Unresectable Ga...	EF5 motexafin lutet... pharmacological...	18 Years -	National Cancer Institute (NCI)
Photodynamic Therapy Using Lutetium Texaphyrin in Treating Patients With Cervical Intraepithelial Neoplasia	NCT00005808	Cervical Cancer Cervical Intrae... Cervical Intrae...	motexafin lutet... photodynamic th... loop electrosur... laboratory biom...	18 Years - 65 Years	National Cancer Institute (NCI)
Photodynamic Therapy With Lutetium Texaphyrin in Treating Patients With Locally Recurrent Prostate Cancer	NCT00005067	Adenocarcinoma ... Recurrent Prost... Stage I Prostat... Stage IIA Prost... Stage IIB Prost...	motexafin lutet... photodynamic th...	18 Years -	National Cancer Institute (NCI)
Photodynamic Therapy Using Lutetium Texaphyrin in Treating Patients With Cervical Intraepithelial Neoplasia	NCT00005808	Cervical Cancer Cervical Intrae... Cervical Intrae...	motexafin lutet... photodynamic th... loop electrosur... laboratory biom...	18 Years - 65 Years	National Cancer Institute (NCI)

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