Immunotoxin Therapy Before and After Surgery in Treating Patients With Recurrent Malignant Glioma (NCT00036972) | Clinical Trial Compass
CompletedPhase 1
Immunotoxin Therapy Before and After Surgery in Treating Patients With Recurrent Malignant Glioma
United StatesStarted 2001-11
Plain-language summary
RATIONALE: Immunotoxins can locate tumor cells and kill them without harming normal cells. Immunotoxin therapy may be effective in treating malignant glioma.
PURPOSE: Phase I trial to study the effectiveness of immunotoxin therapy before and after surgery in treating patients who have recurrent malignant glioma.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically confirmed supratentorial malignant glioma (grade 3 or 4)
* Anaplastic astrocytoma
* Glioblastoma multiforme
* Mixed oligoastrocytoma
* Malignant astrocytoma, not otherwise specified
* Prior first resection of brain tumor
* Prior cranial radiotherapy with tumor dose of at least 48 Gy
* Radiographic evidence of recurrent or progressive supratentorial tumor
* In patients who have received external beam radiotherapy or localized radiotherapy (e.g., gamma-knife or brachytherapy) within the past 12 weeks, progression must be confirmed by metabolic imaging (magnetic resonance spectroscopy or positron-emission tomography)
* Must be a candidate for second resection
* No signs of impending herniation
* No midline shift greater than 1 cm
* No multifocal disease or subependymal tumor spread
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 70-100%
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 9 g/dL
Hepatic:
* PT and PTT no greater than upper limit of normal
Renal:
* Not specified
Other:
* No uncontrolled seizures
* No other neurologic condition that would interfere with study evaluation
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception during and for 60 days after study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.