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- Last updated refers to the date when our listing for each treatment was last updated.
- ID is our internal ID - starting with VT.
- Min Karnofsky is a general guide to how well you have to function to use this treatment
- For trials that also have a NCT number, you can click that number to pop up the listing from the clinicaltrials.gov website.
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Treatment Name: |
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A Phase I Imaging and Safety Study of Intravenous 131-I-TM-601 Labelled Chlorotoxin In Patients with Recurrent or Refractory Somatic and/or Cereberal Metastatic Solid Tumors |
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Keywords: |
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131-I-TM-601 |
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Phase: |
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Phase 1 |
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Treatment ID#s: |
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VT1740
NCT00379132
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Age Group: |
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Adults Only |
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Min Karnofsky Score: |
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60: Requires occasional assistance but is able to care for most of own needs |
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Conditions: |
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Newly Diagnosed: N
Recurrent: Y
Prior Surgery is Allowed
Prior Radiation is Allowed
Prior Chemotherapy is Allowed
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 adenocarincoma (hormone refractory) or glioma.
- Demonstration of distant metastatic involvement as seen with CT/MRI or on biopsy. Note: on a case-by-case basis, patients with a locally recurrent, unresectable (inoperable) primary tumor may be considered for inclusion in the absence of metastatic disease.
- Patient is 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
- Subjects who have not sufficienty 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 concurrent 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;
- Patients with a 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.
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Last Updated: |
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06/04/2007 |
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Tumor Types: |
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Glioblastoma Multiforme
Metastatic Brain Tumor
Mixed Glioma |
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Comments: |
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This is a multi-center open label, non-randomized, sequential "within subject" dose-escalation study in subjects with metastatic (including cerebral metastases) primary solid tumors. Subjects will be administered 1-3 escalating doses (Test Doses A, B and Dose C) of 131-I-TM-601 by intravenous (I.V.) administration, with dosimetry (image-based evaluation of dose reaching the target sites) conducted prior to administration of Test Dose B and Dose C. Whole body dosimetry on critical structures including, but not limited to, bone marrow, bladder, brain, liver and tyroid will be determined. The preliminary results from Test Dose Levels (A and/or B)for each subject will be analyzed prior to treating patients with Dose C. It is anticipated that approximately thirty subjects will be enrolled to acheive adequate imaging for twenty subjects at Dose C.
Patients will be followed until 28 days following the final dose. |
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Treatment Type: |
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Radiation
Less-Toxics
Immunological, Biological or Targeted Therapy. |
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Contact: |
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University of Alabama at Birmingham Comprehensive Cancer Center
John Fiveash, MD
Birmingham, AL 35294-3300
Phone:205-975-0224
Email not available
Northwestern University, The Robert H. Lurie Comprehensive Cancer Center
Jeffrey Raizer, MD
Director, Medical Neuro-oncology
Contact: Lilia Gallot, MD, CCRC
Chicago, IL 60611
Phone:312-695-1363
Click here to send an email
TransMolecular, Inc.
Judy Burns
Clinical Operations
840 Memorial Drive
Cambridge, MA 02129
Phone:617-995-3050 x 318
Click here to send an email
Website: transmolecular.com
Lacks Cancer Center
Thomas Gribbin, MD
Contact: Nancy White
Grand Rapids, MI 49503
Phone:616-752-5252
Click here to send an email
Mary Crowley Medical Research Center
Neil Senzer, MD
Contact: Paige Sovern, RN
Dallas, TX 75246
Phone:214-658-1941
Click here to send an email |
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