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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

Phase 1
18 Years
Not Enrolling
Breast Cancer, Non-Small Cell Lung Cancer, Melanoma, Colorectal Cancer, Pancreatic Cancer, Prostate Adenocarcinoma, Glioma, Primary Solid Tumors

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Trial Information

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

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.

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

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

between 1 - 72 hours post study dose

Safety Issue:


Principal Investigator

John Fiveash, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Alabama at Birmingham


United States: Food and Drug Administration

Study ID:




Start Date:

August 2006

Completion Date:

August 2008

Related Keywords:

  • Breast Cancer
  • Non-Small Cell Lung Cancer
  • Melanoma
  • Colorectal Cancer
  • Pancreatic Cancer
  • Prostate Adenocarcinoma
  • Glioma
  • Primary Solid Tumors
  • Glioma
  • prostatic
  • breast
  • non-small cell lung
  • melanoma
  • colorectal
  • pancreatic
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Breast Neoplasms
  • Prostatic Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Colorectal Neoplasms
  • Glioma
  • Lung Neoplasms
  • Melanoma
  • Pancreatic Neoplasms
  • Neoplasms



Tufts - New England Medical Center Boston, Massachusetts  02111
Mary Crowley Medical Research Center Dallas, Texas  75246
University of Alabama at Birmingham Birmingham, Alabama  35294-3300
University of Chicago Chicago, Illinois  60637
Lacks Cancer Center at St. Mary's Health Care Grand Rapids, Michigan  49503
Northwestern University, The Robert H. Lurie Comprehensive Cancer Center Chicago, Illinois  60611