131-I-TM-601 Study in Adults With Solid Tumors
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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 |
- 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) |
-
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)
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 |
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| 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 |
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 Adenocarcinoma, Mucinous 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, Cystic, Mucinous, and Serous |
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 |
ClinicalTrials.gov processed this record on May 16, 2013