131-I-TM-601 Study in Adults With Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00379132
Recruitment Status : Completed
First Posted : September 21, 2006
Last Update Posted : March 31, 2009
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Brief Summary:
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 or disease Intervention/treatment Phase
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 1

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : August 2006
Actual Primary Completion Date : July 2008
Actual Study Completion Date : August 2008

Intervention Details:
  • Drug: 131-I-TM-601 (chlorotoxin)

    Patients will be administered 1 - 3 (Test Doses A, B, and Dose C) escalating doses of 131I-TM601 by intravenous (IV) administration. Each dose will be administered as a single administration, scheduled at one-week intervals.

    Test Dose A - 10 mCi (+/- 20%)/0.2 mg TM601 (131I-TM601) Test Dose B - 20 mCi (+/- 20%)/0.4 mg TM601 (131I-TM601) Dose C - 30 mCi (+/- 10%)/0.6 mg TM601 (131I-TM601)

Primary Outcome Measures :
  1. To evaluate whether intravenous (IV) 131-I-TM-601 provides tumor-specific localization in patients with recurrent or refractory metastatic (including brain metastases) solid tumors [ Time Frame: between 1 - 72 hours post study dose ]
  2. To determine the distribution and dosimetry of intravenously administered 131-I-TM-601 [ Time Frame: between 1 - 72 hours post study dose ]
  3. To determine the safety and tolerability of IV administered 131-I-TM-601. [ Time Frame: within 28 days of last study drug administration ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically confirmed recurrent or refractory primary solid tumor malignancy. Primary tumor cell type is one of the following: breast, non-small cell lung, melanoma, colorectal, prostatic adenocarcinoma (hormone refractory) or glioma. Note: Patients with a primary solid tumor cell type not listed above, meeting all other selection criteria may be considered eligible, on a case by case basis
  • Demonstration of distant metastatic involvement as seen with standard clinical non-invasive imaging techniques (CT/MRI) or on biopsy. Note: on a case-by-case basis, patients with a locally recurrent, unresectable (inoperable) tumor may be considered for inclusion
  • Refractory to standard curative treatment
  • At least 18 years of age
  • Baseline Karnofsky Performance Status (KPS) of 60-100%
  • Life expectancy, based on investigator judgement, of greater than 3 months
  • Adequate organ and marrow function (as defined in protocol)
  • Women of child-bearing potential must have a negative pregnancy test, refrain from nursing, and must agree to use appropriate contraception for the duration of the trial

Exclusion Criteria:

  • Prior cytotoxic chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
  • Patients who have not sufficiently recovered from adverse events due to previously administered agents
  • Concurrent treatment with investigational or commercial agents or therapies administered with the intent to treat the patient's malignancy, including chemotherapy, immunotherapy, biological response modifiers, or palliative radiotherapy. Possible exceptions (at the discretion of the investigator) are for hormonal therapy for breast and prostate cancer, hematologic, analgesic, biphosphonate, and any other form of supportive therapy.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to 131-I-labeled chlorotoxin (e.g. iodine or iodine-containing drugs)
  • Patients with uncontrolled intercurrent illness.

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 identifier (NCT number): NCT00379132

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
Sponsors and Collaborators
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: Susan Stewart, Vice President, Regulatory Affairs, TransMolecular, Inc. Identifier: NCT00379132     History of Changes
Other Study ID Numbers: TM601-003
First Posted: September 21, 2006    Key Record Dates
Last Update Posted: March 31, 2009
Last Verified: March 2009

Keywords provided by TransMolecular:
non-small cell lung

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Pancreatic Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases