Dalteparin and Radiation Therapy in Treating Patients With Newly Diagnosed Supratentorial Gliobla… (NCT00028678) | Clinical Trial Compass
CompletedPhase 2
Dalteparin and Radiation Therapy in Treating Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme
United States45 participantsStarted 2002-07-11
Plain-language summary
RATIONALE: Dalteparin may stop the growth of cancer by stopping blood flow to the tumor and by blocking the enzymes necessary for tumor cell growth. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining dalteparin with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining dalteparin with radiation therapy in treating patients who have newly diagnosed supratentorial glioblastoma multiforme.
Who can participate
Age range
18 Years – 120 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 or cytologically confirmed newly diagnosed supratentorial glioblastoma multiforme
* At least 2 weeks but no more than 4 weeks since prior surgery
* Patients with biopsy only must be at least 1 week past surgery
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Platelet count at least 100,000/mm\^3
* No history of heparin-induced thrombocytopenia
* No coagulopathy
Hepatic:
* Bilirubin no greater than 2.5 mg/dL
* AST no greater than 3 times upper limit of normal (ULN)
* PT/aPTT no greater than 1.5 times ULN
Renal:
* Creatinine no greater than 2.0 mg/dL
* No gross hematuria within the past 6 months
Cardiovascular:
* No uncontrolled hypertension
* No unstable angina
* No symptomatic congestive heart failure
* No myocardial infarction within the past 6 months
* No uncontrolled cardiac arrhythmia
Gastrointestinal:
* No peptic ulcer disease within the past 6 months
* Negative stool guaiac
* Negative endoscopy required if positive stool guaiac
Other:
* No known hypersensitivity to dalteparin, heparin, or pork products
* No CNS trauma within the past 3 months
* No intracranial or intraocular hemorrhage, unless related to surgery, within the past 6 months
* No retinal detachment within the past 6 months
* No other concurrent malignancy receiving treatment
* No active infection
* No AIDS-related illness
* HIV negative
* Must weigh at least 90 pou…
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.