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131-I-TM-601 Study in Adults With Recurrent High-Grade Glioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00114309
Recruitment Status : Unknown
Verified April 2009 by TransMolecular.
Recruitment status was:  Active, not recruiting
First Posted : June 14, 2005
Last Update Posted : April 3, 2009
Information provided by:

Brief Summary:
This drug is being developed to treat a type of brain cancer, glioma. This study was developed to evaluate the safety, time to disease progression and survival rates after treatment.

Condition or disease Intervention/treatment Phase
Malignant Glioma Glioblastoma Multiforme GBM Anaplastic Astrocytoma Oligo-Astrocytoma Gliosarcoma Drug: 131-I-TM-601 Drug: 131I-TM601 Phase 2

Detailed Description:

This phase II trial was designed in two sequences. The first sequence, which is now complete to accrual was an open-label, dose escalation, multi-dose study and treated 12 evaluable patients with high-grade glioma.

The second sequence is currently open and accruing eligible subjects with high-grade glioma. The trial is an open-label, randomized study and will accrue a total of 54 evaluable patients. Eligible subjects will be randomized to receive either 3 or 6 injections of 131-I labeled TM-601 (131-I-TM-601), in weekly intervals at the dose determined in the first sequence of the trial. Patients will undergo debulking surgery and placement of a ventricular access device into the tumor cavity for administration of 131I-TM-601. Patients who participated in the first sequence are not eligible to participate in the second sequence of the study.

High-grade gliomas include; glioblastoma multiforme, anaplastic astrocytoma, oligoastrocytoma or gliosarcoma.

Patients will undergo follow-up clinical examinations and magnetic resonance imaging (MRI) assessments, at defined intervals, until 12 months after the first study dose.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Open-Label, Multiple-Dose Study of Intracavitary Administered 131-I-TM-601 in Adult Patients With Recurrent High-Grade Glioma
Study Start Date : November 2004
Actual Primary Completion Date : March 2009
Estimated Study Completion Date : August 2009

Arm Intervention/treatment
Experimental: 1
3 Dose Regimen
Drug: 131-I-TM-601
131I-TM601, in solution, delivered intracavitarily following surgical resection 3 weekly administrations, 0.8 mg TM601 and 40mCi 131Iodine, per dose.
Other Name: chlorotoxin

Experimental: 2
6 Dose Regimen
Drug: 131I-TM601
131I-TM601, in solution, delivered intracavitarily following surgical resection 6 weekly administrations, 0.8 mg TM601 and 40mCi 131Iodine, per dose.
Other Name: chlorotoxin

Primary Outcome Measures :
  1. Determine Maximum Tolerated Dose (MTD) of 131-I-TM-601 administered intracavitary to patients with recurrent high-grade glioma [ Time Frame: 28 days post last dose ]
  2. Determine the toxicity of a three (3) and six (6) dose cycle of 131-I-TM-601 administrations into the tumor resection site of patients with recurrent high-grade glioma [ Time Frame: 28 days post last dose and then at 3 month intervals from first dose, until disease progression ]
  3. Evaluate the 6 and 12-month rate of progression and survival of patients with recurrent high-grade glioma treated with a three (3) or six (6) dose cycle of 131-I-TM-601 [ Time Frame: at 3 month intervals from first dose administration, until disease progression ]
  4. Evaluate the overall time to progression and death of patients with recurrent high-grade glioma treated with either a three (3) or six (6) dose cycle of 131-I-TM-601 [ Time Frame: at 3 month intervals until disease progression ]

Secondary Outcome Measures :
  1. Evaluate if either a three (3) or six (6) dose cycle of 131-I-TM-601 affects Quality of Life [ Time Frame: 3 month intervals until disease progression ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient must have a histologically confirmed unilateral, supratentorial malignant glioma (grade 3 or 4, anaplastic astrocytoma, gliosarcoma, glioblastoma multiforme or malignant oligoastrocytoma)
  • Patient must have glioma progression or recurrence following radiotherapy that was no less than 50 Gy (+/- chemotherapy; +/- surgery)
  • Patient must be a candidate for resection of the recurrent tumor (surgical requirements are detailed in the study protocol)
  • Imaging must show recurrent, unilateral, supratentorial tumor(s)
  • There is no diffuse leptomeningeal disease
  • For patients with previous radiosurgery or enhanced radiotherapy, based on neurosurgeon's judgment, the area of enhancement can be removed during the surgery
  • Patient must have recovered from toxicity of prior therapy
  • Patient must be > 18 years of age.
  • Patient has a Karnofsky Performance Status greater than or equal to 60%
  • Patient must have a life expectancy of at least 3 months
  • Patient has no uncontrolled seizures or other neurological conditions which would interfere with evaluation
  • Patient is not currently receiving, or is not anticipated to receive, concomitant anticancer agent(s) during the course of this study
  • Patient must have given informed consent

Exclusion Criteria:

  • Patient with concurrent malignancy (except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of cervix and/or breast) or patients with prior malignancies that have not been disease-free for five years
  • Patient has presence of non-contiguous satellite lesions
  • Patient with known allergy to iodine, iodine containing drugs or contrast agent
  • Patient with the potential for pregnancy or impregnating their partner and who do not agree to follow an acceptable birth control method to avoid conception
  • Pregnant or breast feeding females
  • Patient is not maintained on a stable corticosteroid regimen
  • New onset of conditions not present prior to surgery (as detailed in Study Protocol) which would make patient an inappropriate study candidate, or as determined by Investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00114309

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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-3410
United States, California
City of Hope
Duarte, California, United States, 91010
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Florida
Florida Hospital Cancer Institute
Orlando, Florida, United States, 32804
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
University of Chicago
Chicago, Illinois, United States, 60637
United States, Maryland
Johns Hopkins Medical Center
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Tufts-New England Medical Center
Boston, Massachusetts, United States, 02111
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Lacks Cancer Center at St. Mary's Health Care
Grand Rapids, Michigan, United States, 49503
United States, Missouri
St. Louis Hospital
St. Louis, Missouri, United States, 63110
Washington University Medical Center
St. Louis, Missouri, United States, 63110
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, North Carolina
Carolina Neurosurgery and Spine
Charlotte, North Carolina, United States, 28204
United States, Texas
Mary Crowley Medical Research Center
Dallas, Texas, United States, 75246
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
United States, Washington
University of Washington
Seattle, Washington, United States, 98195-6470
Sponsors and Collaborators
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Principal Investigator: John Fiveash, MD University of Alabama at Birmingham

Publications of Results:
Other Publications:
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Responsible Party: Susan Stewart, Vice President, Regulatory Affairs, TransMolecular, Inc. Identifier: NCT00114309     History of Changes
Other Study ID Numbers: TM-601-002
First Posted: June 14, 2005    Key Record Dates
Last Update Posted: April 3, 2009
Last Verified: April 2009

Keywords provided by TransMolecular:
High grade recurrent glioma
Phase II
Open label
Multiple dose
Brain Cancer
Brain Tumor

Additional relevant MeSH terms:
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Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue