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


N/A
18 Years
N/A
Not Enrolling
Both
Advanced Adult Primary Liver Cancer, Carcinoma of the Appendix, Fallopian Tube Cancer, Gastrointestinal Stromal Tumor, Localized Extrahepatic Bile Duct Cancer, Localized Gallbladder Cancer, Localized Gastrointestinal Carcinoid Tumor, Localized Resectable Adult Primary Liver Cancer, Localized Unresectable Adult Primary Liver Cancer, Metastatic Gastrointestinal Carcinoid Tumor, Ovarian Sarcoma, Ovarian Stromal Cancer, Primary Peritoneal Cavity Cancer, Recurrent Adult Primary Liver Cancer, Recurrent Adult Soft Tissue Sarcoma, Recurrent Colon Cancer, Recurrent Extrahepatic Bile Duct Cancer, Recurrent Gallbladder Cancer, Recurrent Gastric Cancer, Recurrent Gastrointestinal Carcinoid Tumor, Recurrent Non-small Cell Lung Cancer, Recurrent Ovarian Epithelial Cancer, Recurrent Ovarian Germ Cell Tumor, Recurrent Pancreatic Cancer, Recurrent Rectal Cancer, Recurrent Small Intestine Cancer, Recurrent Uterine Sarcoma, Regional Gastrointestinal Carcinoid Tumor, Small Intestine Adenocarcinoma, Small Intestine Leiomyosarcoma, Small Intestine Lymphoma, Stage 0 Non-small Cell Lung Cancer, Stage I Adult Soft Tissue Sarcoma, Stage I Colon Cancer, Stage I Gastric Cancer, Stage I Non-small Cell Lung Cancer, Stage I Ovarian Epithelial Cancer, Stage I Ovarian Germ Cell Tumor, Stage I Pancreatic Cancer, Stage I Rectal Cancer, Stage I Uterine Sarcoma, Stage II Adult Soft Tissue Sarcoma, Stage II Colon Cancer, Stage II Gastric Cancer, Stage II Non-small Cell Lung Cancer, Stage II Ovarian Epithelial Cancer, Stage II Ovarian Germ Cell Tumor, Stage II Pancreatic Cancer, Stage II Rectal Cancer, Stage II Uterine Sarcoma, Stage III Adult Soft Tissue Sarcoma, Stage III Colon Cancer, Stage III Gastric Cancer, Stage III Ovarian Epithelial Cancer, Stage III Ovarian Germ Cell Tumor, Stage III Pancreatic Cancer, Stage III Rectal Cancer, Stage III Uterine Sarcoma, Stage IIIA Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Adult Soft Tissue Sarcoma, Stage IV Colon Cancer, Stage IV Gastric Cancer, Stage IV Non-small Cell Lung Cancer, Stage IV Ovarian Epithelial Cancer, Stage IV Ovarian Germ Cell Tumor, Stage IV Pancreatic Cancer, Stage IV Rectal Cancer, Stage IV Uterine Sarcoma, Unresectable Extrahepatic Bile Duct Cancer, Unresectable Gallbladder Cancer

Thank you

Trial Information

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


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.


Inclusion Criteria:



- Histologically confirmed or suspected diagnosis of 1 of the following:

- Intra-abdominal malignancy of 1 of the following types:

- Sarcoma

- Ovarian cancer

- Gastrointestinal malignancies, including, but not limited to, appendiceal
cancer, colon cancer, or gastric cancer

- Non-small cell lung cancer

- Planning to undergo surgical resection of disease

- Disease has the propensity to spread to the peritoneal cavity (intra-abdominal
malignancy patients)

- Performance status - ECOG 0-2

- WBC ≥ 2,000/mm^3

- Platelet count ≥ 100,000/mm^3

- Bilirubin < 1.5 mg/dL

- Creatinine normal

- Creatinine clearance ≥ 60 mL/min

- Body weight ≤ 130 kg

- No G6PD deficiency

- No porphyria

- No history of peripheral neuropathy ≥ grade 3

- Able to tolerate anesthesia and major surgery

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 1 month after study
participation

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Motexafin lutetium uptake in tumors and normal tissues

Outcome Description:

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.

Outcome Time Frame:

At the time of surgery

Safety Issue:

No

Principal Investigator

Stephen Michael Hahn

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02607

NCT ID:

NCT00087191

Start Date:

May 2004

Completion Date:

Related Keywords:

  • Advanced Adult Primary Liver Cancer
  • Carcinoma of the Appendix
  • Fallopian Tube Cancer
  • Gastrointestinal Stromal Tumor
  • Localized Extrahepatic Bile Duct Cancer
  • Localized Gallbladder Cancer
  • Localized Gastrointestinal Carcinoid Tumor
  • Localized Resectable Adult Primary Liver Cancer
  • Localized Unresectable Adult Primary Liver Cancer
  • Metastatic Gastrointestinal Carcinoid Tumor
  • Ovarian Sarcoma
  • Ovarian Stromal Cancer
  • Primary Peritoneal Cavity Cancer
  • Recurrent Adult Primary Liver Cancer
  • Recurrent Adult Soft Tissue Sarcoma
  • Recurrent Colon Cancer
  • Recurrent Extrahepatic Bile Duct Cancer
  • Recurrent Gallbladder Cancer
  • Recurrent Gastric Cancer
  • Recurrent Gastrointestinal Carcinoid Tumor
  • Recurrent Non-Small Cell Lung Cancer
  • Recurrent Ovarian Epithelial Cancer
  • Recurrent Ovarian Germ Cell Tumor
  • Recurrent Pancreatic Cancer
  • Recurrent Rectal Cancer
  • Recurrent Small Intestine Cancer
  • Recurrent Uterine Sarcoma
  • Regional Gastrointestinal Carcinoid Tumor
  • Small Intestine Adenocarcinoma
  • Small Intestine Leiomyosarcoma
  • Small Intestine Lymphoma
  • Stage 0 Non-small Cell Lung Cancer
  • Stage I Adult Soft Tissue Sarcoma
  • Stage I Colon Cancer
  • Stage I Gastric Cancer
  • Stage I Non-small Cell Lung Cancer
  • Stage I Ovarian Epithelial Cancer
  • Stage I Ovarian Germ Cell Tumor
  • Stage I Pancreatic Cancer
  • Stage I Rectal Cancer
  • Stage I Uterine Sarcoma
  • Stage II Adult Soft Tissue Sarcoma
  • Stage II Colon Cancer
  • Stage II Gastric Cancer
  • Stage II Non-Small Cell Lung Cancer
  • Stage II Ovarian Epithelial Cancer
  • Stage II Ovarian Germ Cell Tumor
  • Stage II Pancreatic Cancer
  • Stage II Rectal Cancer
  • Stage II Uterine Sarcoma
  • Stage III Adult Soft Tissue Sarcoma
  • Stage III Colon Cancer
  • Stage III Gastric Cancer
  • Stage III Ovarian Epithelial Cancer
  • Stage III Ovarian Germ Cell Tumor
  • Stage III Pancreatic Cancer
  • Stage III Rectal Cancer
  • Stage III Uterine Sarcoma
  • Stage IIIA Non-Small Cell Lung Cancer
  • Stage IIIB Non-Small Cell Lung Cancer
  • Stage IV Adult Soft Tissue Sarcoma
  • Stage IV Colon Cancer
  • Stage IV Gastric Cancer
  • Stage IV Non-Small Cell Lung Cancer
  • Stage IV Ovarian Epithelial Cancer
  • Stage IV Ovarian Germ Cell Tumor
  • Stage IV Pancreatic Cancer
  • Stage IV Rectal Cancer
  • Stage IV Uterine Sarcoma
  • Unresectable Extrahepatic Bile Duct Cancer
  • Unresectable Gallbladder Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoid Tumor
  • Carcinoma
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Leiomyosarcoma
  • Liver Neoplasms
  • Lung Neoplasms
  • Lymphoma
  • Stomach Neoplasms
  • Pancreatic Neoplasms
  • Duodenal Neoplasms
  • Ileal Neoplasms
  • Jejunal Neoplasms
  • Gallbladder Neoplasms
  • Bile Duct Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Germ Cell and Embryonal
  • Sarcoma
  • Malignant Carcinoid Syndrome
  • Gastrointestinal Neoplasms
  • Gastrointestinal Stromal Tumors
  • Germinoma
  • Ovarian Neoplasms
  • Intestinal Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location
Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283