Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:16 PM
Ignite Modification Date:
2025-12-24 @ 10:16 PM
NCT ID:
NCT00128635
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed glioblastoma multiforme
* Focal disease
* Progressive or recurrent disease after prior treatment with radiotherapy and/or chemotherapy
* Low-grade astrocytoma that progressed to glioblastoma multiforme after prior radiotherapy and/or chemotherapy allowed
* Gross tumor volume 5-60 mL
* No intraventricular tumor, infratentorial tumor, or tumor that communicates with the ventricles
* No bilateral non-contiguous gadolinium-enhancing tumor
* No diffuse disease, defined as any satellite lesion \> 1.5 cm from the anticipated location of a catheter tip OR \> 2 satellite lesions
* No ventricular invasion outside the anticipated radiotherapy volume
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Karnofsky 60-100%
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 9.0 g/dL
Hepatic
* Bilirubin ≤ 1.5 mg/dL
* AST and ALT ≤ 2.5 times upper limit of normal (ULN)
* Hepatitis B negative
* No evidence of active hepatitis
Renal
* Creatinine ≤ 1.7 mg/dL
* BUN ≤ 2 times ULN
Cardiovascular
* No uncontrolled hypertension
* No unstable angina pectoris
* No uncontrolled cardiac dysrhythmia
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Able to undergo MRI
* Mini Mental State Exam score ≥ 15
* No serious infection
* No other medical illness that would preclude study participation
* No other malignancy within the past 5 years except curatively treated carcinoma in situ or basal cell skin cancer
* No psychological or sociological condition, addictive disorder, or other condition that would preclude study compliance
* No known or suspected allergy to study drug or iodine
* No known HIV positivity
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior monoclonal antibodies
* No prior local immunotherapy or treatment with the following biologic agents:
* Immunotoxins
* Immunoconjugates
* Antiangiogenesis compounds
* Antisense agents
* Peptide receptor antagonist
* Interferons
* Interleukins
* Tumor infiltrating lymphocytes
* Lymphokine-activated killer cells
* Gene therapy
Chemotherapy
* See Disease Characteristics
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
* At least 3 months since prior polifeprosan 20 with carmustine implant (Gliadel wafer\^® )
Endocrine therapy
* Must be maintained on a stable corticosteroid dose (approximately 4 mg) for ≥ 2 weeks before study entry
Radiotherapy
* See Disease Characteristics
* At least 3 months since prior radiotherapy
* No prior brachytherapy or radiosurgery
Surgery
* At least 4 weeks since prior surgery
Other
* Recovered from all prior therapy
* At least 1 month since prior investigational agents
* No more than 2 prior treatment regimens
* No other prior local therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00128635
Study Brief:
Protocol Section:
NCT00128635