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

This study has been completed.
Sponsor:
Information provided by:
TransMolecular
ClinicalTrials.gov Identifier:
NCT00379132
First received: September 18, 2006
Last updated: March 30, 2009
Last verified: March 2009
  Purpose

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
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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by TransMolecular:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • To determine the distribution and dosimetry of intravenously administered 131-I-TM-601 [ Time Frame: between 1 - 72 hours post study dose ] [ Designated as safety issue: Yes ]
  • To determine the safety and tolerability of IV administered 131-I-TM-601. [ Time Frame: within 28 days of last study drug administration ] [ Designated as safety issue: Yes ]

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)
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00379132

Locations
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
TransMolecular
Investigators
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
  More Information

Publications:
Responsible Party: Susan Stewart, Vice President, Regulatory Affairs, TransMolecular, Inc.
ClinicalTrials.gov Identifier: NCT00379132     History of Changes
Other Study ID Numbers: TM601-003
Study First Received: September 18, 2006
Last Updated: March 30, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by TransMolecular:
Glioma
prostatic
breast
non-small cell lung
melanoma
colorectal
pancreatic

Additional relevant MeSH terms:
Adenocarcinoma
Breast Neoplasms
Prostatic Neoplasms
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Glioma
Lung Neoplasms
Melanoma
Pancreatic Neoplasms
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Breast Diseases
Skin Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases

ClinicalTrials.gov processed this record on September 14, 2014