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 @ 7:43 PM
Ignite Modification Date:
2025-12-24 @ 7:43 PM
NCT ID:
NCT00390403
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed supratentorial grade IV astrocytoma (glioblastoma multiforme)
* Meets 1 of the following criteria:
* Completed surgery within the past 6 weeks (group I)
* Received radiotherapy and concomitant temozolomide at least 4 weeks but no more than 7 weeks prior to start of study treatment (group II)
* Must be on a stable corticosteroid regimen (no increase for 5 days)
PATIENT CHARACTERISTICS:
* Karnofsky performance status 60-100%
* Hemoglobin ≥ 10 g/dL
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Creatinine ≤1.5 mg/dL
* Bilirubin ≤ 1.5 mg/dL
* ALT and AST ≤ 2.5 times upper limit of normal
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 2 months after completion of study treatment
* Mini Mental State Exam score ≥ 15
* Must be able to swallow and retain oral medication
* No serious concurrent infection or medical illness that would preclude study participation
* No other malignancy within the past 5 years, except for curatively treated carcinoma in situ or basal cell carcinoma of the skin
* No sensory neuropathy ≥ grade 2
* No allergies to gossypol
* No symptomatic hypercalcemia or hypercalcemia \> grade 2
* No gastrointestinal disease including any of the following:
* Malabsorption syndrome
* Disease significantly affecting gastrointestinal function
* Ulcerative colitis
* Inflammatory bowel disease
* Partial or complete small bowel obstruction
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Recovered from the immediate postoperative period
* No prior radiotherapy, chemotherapy, immunotherapy, therapy with biologic agents (including immunotoxins, immunoconjugates, antisense agents, peptide-receptor antagonists, interferons, interleukins, tumor-infiltrating lymphocyte therapy, lymphokine-activated killer cells or gene therapy), or hormonal therapy for this brain tumor (group I)
* Prior glucocorticoid therapy allowed
* No prior polifeprosan 20 with carmustine implant (Gliadel wafers) (group I)
* No prior gossypol
* No prior radiosurgery or brachytherapy
* No prior resection of the stomach or small intestine
* No other concurrent anticancer therapy (i.e., chemotherapeutics or investigational agents)
* No concurrent cytochrome p450 enzyme-inducing anticonvulsant drugs
* No concurrent prophylactic filgrastim (G-CSF)
* No concurrent iron supplements
* Nutritional supplements containing iron allowed
* No concurrent intensity-modulated radiotherapy
* No concurrent electron, particle, implant, or stereotactic radiosurgery boost
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00390403
Study Brief:
Protocol Section:
NCT00390403