Glioblastoma Multiforme Clinical Trial
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
Verified date | April 2009 |
Source | TransMolecular |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 66 |
Est. completion date | August 2009 |
Est. primary completion date | March 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Emory University | Atlanta | Georgia |
United States | Johns Hopkins Medical Center | Baltimore | Maryland |
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | Tufts-New England Medical Center | Boston | Massachusetts |
United States | Carolina Neurosurgery and Spine | Charlotte | North Carolina |
United States | Northwestern University | Chicago | Illinois |
United States | University of Chicago | Chicago | Illinois |
United States | Mary Crowley Medical Research Center | Dallas | Texas |
United States | Henry Ford Hospital | Detroit | Michigan |
United States | City of Hope | Duarte | California |
United States | Lacks Cancer Center at St. Mary's Health Care | Grand Rapids | Michigan |
United States | Cedars-Sinai Medical Center | Los Angeles | California |
United States | Columbia University Medical Center | New York | New York |
United States | Florida Hospital Cancer Institute | Orlando | Florida |
United States | Huntsman Cancer Institute | Salt Lake City | Utah |
United States | University of Washington | Seattle | Washington |
United States | St. Louis Hospital | St. Louis | Missouri |
United States | Washington University Medical Center | St. Louis | Missouri |
United States | Moffitt Cancer Center | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
TransMolecular |
United States,
Hockaday 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. — View Citation
Lyons 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. — View Citation
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. Review. — View Citation
Mamelak 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-60 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determine Maximum Tolerated Dose (MTD) of 131-I-TM-601 administered intracavitary to patients with recurrent high-grade glioma | 28 days post last dose | Yes | |
Primary | 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 | Yes | |
Primary | 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 | No | |
Primary | 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 | No | |
Secondary | 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 | No |
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