Status:
UNKNOWN
131-I-TM-601 Study in Adults With Recurrent High-Grade Glioma
Lead Sponsor:
TransMolecular
Conditions:
Malignant Glioma
Glioblastoma Multiforme
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2009
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00114309
Start Date
November 1 2004
End Date
August 1 2009
Last Update
April 3 2009
Active Locations (19)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-3410
2
City of Hope
Duarte, California, United States, 91010
3
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
4
Florida Hospital Cancer Institute
Orlando, Florida, United States, 32804