Clinical trial · Interventional
Dalteparin and Radiation Therapy in Treating Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme
A Phase II Study to Evaluate the Effect of Dalteparin and Radiation Therapy on Survival Compared to the RTOG RPA Database and on Thromboembolic Events in Patients With Newly Diagnosed Glioblastoma Multiforme
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dalteparin | Drug | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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 pounds (40 kg) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent immunomodulators * No concurrent investigational matrix metalloproteinase inhibitors or antiangiogenesis agents Chemotherapy: * Prior chemotherapy for other malignancy allowed * No concurrent standard or investigational cytotoxic chemotherapy Endocrine therapy: * Not specified Radiotherapy: * No prior cranial irradiation * Prior radiotherapy for other malignancy allowed * Concurrent radiotherapy allowed Surgery: * See Disease Characteristics * Recovered from prior surgery * No prior eye or ear surgery Other: * No concurrent nonsteroidal anti-inflammatory drugs * No ongoing or concurrent aspirin or anticoagulation therapy except routine central venous catheter flushing * No other concurrent non-protocol therapy
References
Publications (1)
- RESULTRobins HI, O'Neill A, Gilbert M, Olsen M, Sapiente R, Berkey B, Mehta M. Effect of dalteparin and radiation on survival and thromboembolic events in glioblastoma multiforme: a phase II ECOG trial. Cancer Chemother Pharmacol. 2008 Jul;62(2):227-33. doi: 10.1007/s00280-007-0596-3. Epub 2007 Sep 20. PMID 17882417