Dalteparin and Radiation Therapy in Treating Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: dalteparin Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | 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 |
| Study Start Date: | May 2002 |
| Primary Completion Date: | July 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine whether dalteparin, initiated at the time of conventional radiotherapy, improves the median survival of patients with newly diagnosed supratentorial glioblastoma multiforme.
- Determine the time to progression in patients treated with this regimen.
- Determine the incidence of thromboembolic events in patients treated with this regimen.
- Determine the feasibility and toxicity of dalteparin in this patient population.
OUTLINE: This is a multicenter study.
Patients undergo cranial irradiation 5 days a week for 7 weeks. Beginning concurrently with initiation of radiotherapy, patients receive dalteparin subcutaneously once daily for up to 2 years in the absence of unacceptable toxicity. Patients may continue receiving dalteparin after year 2 at the discretion of the investigator.
Patients are followed every 3 months for 2 years and then every 6 months for up to 5 years after study entry.
PROJECTED ACCRUAL: A total of 72 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Florida | |
| H. Lee Moffitt Cancer Center and Research Institute | |
| Tampa, Florida, United States, 33612-9497 | |
| United States, Illinois | |
| CCOP - Carle Cancer Center | |
| Urbana, Illinois, United States, 61801 | |
| United States, Michigan | |
| CCOP - Kalamazoo | |
| Kalamazoo, Michigan, United States, 49007-3731 | |
| West Michigan Cancer Center | |
| Kalamazoo, Michigan, United States, 49007 | |
| United States, Minnesota | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| CCOP - Metro-Minnesota | |
| Saint Louis Park, Minnesota, United States, 55416 | |
| United States, New Hampshire | |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756-0002 | |
| United States, Oklahoma | |
| CCOP - Oklahoma | |
| Tulsa, Oklahoma, United States, 74136 | |
| United States, Tennessee | |
| Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center | |
| Nashville, Tennessee, United States, 37232-6307 | |
| United States, Texas | |
| CCOP - Scott and White Hospital | |
| Temple, Texas, United States, 76508 | |
| United States, Wisconsin | |
| CCOP - St. Vincent Hospital Cancer Center, Green Bay | |
| Green Bay, Wisconsin, United States, 54307-3453 | |
| University of Wisconsin Comprehensive Cancer Center | |
| Madison, Wisconsin, United States, 53792-0001 | |
| Study Chair: | H. I. Robins, MD, PhD | University of Wisconsin, Madison |
More Information
Additional Information:
Publications:
| Responsible Party: | Group Chair, Eastern Cooperative Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00028678 History of Changes |
| Other Study ID Numbers: | CDR0000069119, E1F01 |
| Study First Received: | January 4, 2002 |
| Last Updated: | January 26, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Eastern Cooperative Oncology Group:
|
adult glioblastoma adult giant cell glioblastoma adult gliosarcoma |
Additional relevant MeSH terms:
|
Glioblastoma Nervous System Neoplasms Central Nervous System Neoplasms Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
Neoplasms by Site Nervous System Diseases Dalteparin Heparin, Low-Molecular-Weight Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 21, 2013