131-I-TM-601 Study in Adults With Recurrent High-Grade Glioma
A Phase II Open-Label, Multiple-Dose Study of Intracavitary Administered 131-I-TM-601 in Adult Patients With Recurrent High-Grade Glioma
1 other identifier
interventional
66
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2004
Longer than P75 for phase_2
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 13, 2005
CompletedFirst Posted
Study publicly available on registry
June 14, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedApril 3, 2009
April 1, 2009
4.3 years
June 13, 2005
April 1, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Determine Maximum Tolerated Dose (MTD) of 131-I-TM-601 administered intracavitary to patients with recurrent high-grade glioma
28 days post last dose
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
28 days post last dose and then at 3 month intervals from first dose, until disease progression
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
at 3 month intervals from first dose administration, until disease progression
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
at 3 month intervals until disease progression
Secondary Outcomes (1)
Evaluate if either a three (3) or six (6) dose cycle of 131-I-TM-601 affects Quality of Life
3 month intervals until disease progression
Study Arms (2)
1
EXPERIMENTAL3 Dose Regimen
2
EXPERIMENTAL6 Dose Regimen
Interventions
131I-TM601, in solution, delivered intracavitarily following surgical resection 6 weekly administrations, 0.8 mg TM601 and 40mCi 131Iodine, per dose.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- TransMolecularlead
Study Sites (19)
University of Alabama at Birmingham
Birmingham, Alabama, 35294-3410, United States
City of Hope
Duarte, California, 91010, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Florida Hospital Cancer Institute
Orlando, Florida, 32804, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Emory University
Atlanta, Georgia, 30322, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Chicago
Chicago, Illinois, 60637, United States
Johns Hopkins Medical Center
Baltimore, Maryland, 21287, United States
Tufts-New England Medical Center
Boston, Massachusetts, 02111, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Lacks Cancer Center at St. Mary's Health Care
Grand Rapids, Michigan, 49503, United States
St. Louis Hospital
St Louis, Missouri, 63110, United States
Washington University Medical Center
St Louis, Missouri, 63110, United States
Columbia University Medical Center
New York, New York, 10032, United States
Carolina Neurosurgery and Spine
Charlotte, North Carolina, 28204, United States
Mary Crowley Medical Research Center
Dallas, Texas, 75246, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
University of Washington
Seattle, Washington, 98195-6470, United States
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: 17335414BACKGROUNDLyons 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: 12112367BACKGROUNDMamelak 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: 16877732RESULTHockaday 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: 15809479RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John Fiveash, MD
University of Alabama at Birmingham
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 13, 2005
First Posted
June 14, 2005
Study Start
November 1, 2004
Primary Completion
March 1, 2009
Study Completion
August 1, 2009
Last Updated
April 3, 2009
Record last verified: 2009-04