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

Primary Purpose

Breast Cancer, Non-Small Cell Lung Cancer, Melanoma

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

131-I-TM-601 (chlorotoxin)

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Glioma, prostatic, breast, non-small cell lung, melanoma, colorectal, pancreatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Alabama at Birmingham
Northwestern University, The Robert H. Lurie Comprehensive Cancer Center
University of Chicago
Tufts - New England Medical Center
Lacks Cancer Center at St. Mary's Health Care
Mary Crowley Medical Research Center

Outcomes

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

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00379132

First Posted

September 18, 2006

Last Updated

March 30, 2009

Sponsor

TransMolecular

1. Study Identification

Unique Protocol Identification Number

NCT00379132

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

March 2009

Overall Recruitment Status

Completed

Study Start Date

August 2006 (undefined)

Primary Completion Date

July 2008 (Actual)

Study Completion Date

August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

TransMolecular

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

131-I-TM-601 (chlorotoxin)

Intervention Description

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 Measure Information:

Title

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

Title

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

Time Frame

between 1 - 72 hours post study dose

Title

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

Time Frame

within 28 days of last study drug administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials: