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

NCT00379132 | Completed Phase 1

• 1 other identifier: TM601-003
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 6

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.

Conditions

Breast Cancer; Non-Small Cell Lung Cancer; Melanoma; Colorectal Cancer; Pancreatic Cancer; Prostate Adenocarcinoma; Glioma; Primary Solid Tumors

Keywords

Glioma; prostatic; breast; non-small cell lung; melanoma; colorectal; pancreatic

Outcome Measures

Primary Outcomes (3)

• 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

  between 1 - 72 hours post study dose

• To determine the distribution and dosimetry of intravenously administered 131-I-TM-601

  between 1 - 72 hours post study dose

• To determine the safety and tolerability of IV administered 131-I-TM-601.

  within 28 days of last study drug administration

Interventions

131-I-TM-601 (chlorotoxin) DRUG

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• TransMolecular: lead

Study Sites (6)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Northwestern University, The Robert H. Lurie Comprehensive Cancer Center

Chicago, Illinois, 60611, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Tufts - New England Medical Center

Boston, Massachusetts, 02111, United States

Location

Lacks Cancer Center at St. Mary's Health Care

Grand Rapids, Michigan, 49503, United States

Location

Mary Crowley Medical Research Center

Dallas, Texas, 75201, United States

Location

Related Publications (4)

• Mamelak AN, Jacoby DB. Targeted delivery of antitumoral therapy to glioma and other malignancies with synthetic chlorotoxin (TM-601). Expert Opin Drug Deliv. 2007 Mar;4(2):175-86. doi: 10.1517/17425247.4.2.175.

  PMID: 17335414 BACKGROUND

• Mamelak AN, Rosenfeld S, Bucholz R, Raubitschek A, Nabors LB, Fiveash JB, Shen S, Khazaeli MB, Colcher D, Liu A, Osman M, Guthrie B, Schade-Bijur S, Hablitz DM, Alvarez VL, Gonda MA. Phase I single-dose study of intracavitary-administered iodine-131-TM-601 in adults with recurrent high-grade glioma. J Clin Oncol. 2006 Aug 1;24(22):3644-50. doi: 10.1200/JCO.2005.05.4569.

  PMID: 16877732 BACKGROUND

• Hockaday DC, Shen S, Fiveash J, Raubitschek A, Colcher D, Liu A, Alvarez V, Mamelak AN. Imaging glioma extent with 131I-TM-601. J Nucl Med. 2005 Apr;46(4):580-6.

  PMID: 15809479 BACKGROUND

• Lyons SA, O'Neal J, Sontheimer H. Chlorotoxin, a scorpion-derived peptide, specifically binds to gliomas and tumors of neuroectodermal origin. Glia. 2002 Aug;39(2):162-73. doi: 10.1002/glia.10083.

  PMID: 12112367 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Melanoma; Colorectal Neoplasms; Pancreatic Neoplasms; Glioma

Interventions

Chlorotoxin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Neoplasms, Neuroepithelial; Neoplasms, Glandular and Epithelial

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 18, 2006
• First Posted: September 21, 2006
• Study Start: August 1, 2006
• Primary Completion: July 1, 2008
• Study Completion: August 1, 2008
• Last Updated: March 31, 2009

Record last verified: 2009-03

Locations

US (6)