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Sponsored by: |
TransMolecular |
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Information provided by: | TransMolecular |
ClinicalTrials.gov Identifier: | NCT00379132 |
This study is designed to evaluate the ability of intravenously (IV)administered 131-I-labeled TM-601 (chlorotoxin) to provide tumor-specific localization(via radiographic imaging) in patients with recurrent or refractory primary solid tumors with evidence of metastatic involvement.
(Refractory tumors are non-responsive to standard treatment.) The safety and tolerability of IV administered 131-I-TM-601 in this patient population will be evaluated as part of this study.
Condition | Intervention | Phase |
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Breast Cancer Non-Small Cell Lung Cancer Melanoma Colorectal Cancer Pancreatic Cancer Prostate Adenocarcinoma Glioma Primary Solid Tumors |
Drug: 131-I-TM-601 (chlorotoxin) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase I Imaging and Safety Study of Intravenous 131-I-TM-601 Labeled Chlorotoxin in Patients With Recurrent or Refractory Somatic and/or Cerebral Metastatic Solid Tumors |
Estimated Enrollment: | 60 |
Study Start Date: | August 2006 |
Study Completion Date: | August 2008 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
This is a multi-center, open label, non-randomized, sequential, within-patient dose-escalation study in patients with recurrent or refractory primary solid tumors with metastatic involvement (including brain metastases). Patients will be administered 1 to 3 (Test Doses A, B and Dose C) escalating doses of 131-I-TM-601 by intravenous (IV) administration, with dosimetry (imaging-based evaluation of the dose reaching the target sites) conducted prior to and following administration of each dose. Whole body dosimetry on critical structures including, but not limited to, bone marrow, bladder, brain, liver, and thyroid will be determined. The preliminary results from Test Dose Levels (A and/or B) for each patient will be analyzed prior to treating patients with Dose C.
Patients will be followed until 28 days following the final dose, with a complete clinical assessment and imaging evaluations at the final follow-up visit.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
University of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294 | |
United States, Illinois | |
Northwestern University, The Robert H. Lurie Comprehensive Cancer Center | |
Chicago, Illinois, United States, 60611 | |
University of Chicago | |
Chicago, Illinois, United States, 60637 | |
United States, Massachusetts | |
Tufts - New England Medical Center | |
Boston, Massachusetts, United States, 02111 | |
United States, Michigan | |
Lacks Cancer Center at St. Mary's Health Care | |
Grand Rapids, Michigan, United States, 49503 | |
United States, Texas | |
Mary Crowley Medical Research Center | |
Dallas, Texas, United States, 75201 |
Principal Investigator: | John Fiveash, MD | University of Alabama at Birmingham |
Principal Investigator: | Jeffrey Raizer, M.D. | Northwestern University |
Principal Investigator: | Neil Senzer, MD | Mary Crowley Medical Research Center |
Principal Investigator: | Thomas Gribbins, MD | Lacks Cancer Center at St. Mary's Health Care |
Principal Investigator: | Jay-Jiguang Zhu, MD | Tufts Medical Center |
Principal Investigator: | Steven Chmura, MD | University of Chicago |
Responsible Party: | TransMolecular, Inc. ( Susan Stewart, Vice President, Regulatory Affairs ) |
Study ID Numbers: | TM601-003 |
Study First Received: | September 18, 2006 |
Last Updated: | March 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00379132 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Glioma prostatic breast non-small cell lung |
melanoma colorectal pancreatic |
Thoracic Neoplasms Genital Neoplasms, Male Prostatic Diseases Gastrointestinal Diseases Pancreatic Neoplasms Colonic Diseases Urogenital Neoplasms Rectal Diseases Melanoma Respiratory Tract Diseases Lung Neoplasms Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma Glioma |
Breast Diseases Endocrine Gland Neoplasms Digestive System Neoplasms Skin Diseases Endocrine System Diseases Breast Neoplasms Intestinal Diseases Genital Diseases, Male Recurrence Intestinal Neoplasms Neuroendocrine Tumors Carcinoma Neuroectodermal Tumors Digestive System Diseases Lung Diseases |
Thoracic Neoplasms Genital Neoplasms, Male Prostatic Diseases Gastrointestinal Diseases Pancreatic Neoplasms Neoplasms, Nerve Tissue Colonic Diseases Urogenital Neoplasms Rectal Diseases Melanoma Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Neoplasms, Germ Cell and Embryonal Nevi and Melanomas |
Glioma Breast Diseases Endocrine Gland Neoplasms Respiratory Tract Neoplasms Digestive System Neoplasms Neoplasms by Histologic Type Skin Diseases Endocrine System Diseases Breast Neoplasms Intestinal Diseases Genital Diseases, Male Intestinal Neoplasms Neuroendocrine Tumors Carcinoma Neuroectodermal Tumors |