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Home > "D" Clinical Trials Conditions > Dalteparin and Radiation Therapy in Treating Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme  Dalteparin and Radiation Therapy in Treating Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme
Dalteparin and Radiation Therapy in Treating Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme
For Condition: adult glioblastoma multiforme
Status: Recruiting
Sponsor(s): Eastern Cooperative Oncology Group , National Cancer Institute (NCI)
Synopsis: 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 supratentorialglioblastoma multiforme.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
H.Robins, Study Chair, University of Wisconsin Comprehensive Cancer Center
CCOP - Metro-Minnesota *Recruiting*
St. Louis Park, Minnesota, 55416
United States
Recruiting Patrick Flynn 952-993-15175
CCOP - Scott and White Hospital *Recruiting*
Temple, Texas, 76508
United States
Recruiting Lucas Wong 254-724-7048
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Thomas Habermann 507-284-2511
Norris Cotton Cancer Center at Dartmouth Medical School *Recruiting*
Lebanon, New Hampshire, 03756-0002
United States
Recruiting Camilo Fadul 603-650-6312
CCOP - Kalamazoo *Recruiting*
Kalamazoo, Michigan, 49007-3731
United States
Recruiting Raymond Lord 269-373-7488
H. Lee Moffitt Cancer Center and Research Institute *Recruiting*
Tampa, Florida, 33612-9497
United States
Recruiting Cancer Answers 813-972-4673
CCOP - Oklahoma *Recruiting*
Tulsa, Oklahoma, 74136
United States
Recruiting James Lockhart 918-491-5878
CCOP - Carle Cancer Center *Recruiting*
Urbana, Illinois, 61801
United States
Recruiting Kendrith Rowland 217-383-4083
University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison, Wisconsin, 53792-0001
United States
Recruiting James Stewart 608-265-8131
CCOP - St. Vincent Hospital Cancer Center, Green Bay *Recruiting*
Green Bay, Wisconsin, 54307-3453
United States
Recruiting Gerald Bayer 920-433-8889
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center *Recruiting*
Nashville, Tennessee, 37232-6307
United States
Recruiting David Johnson 615-343-9454
Additional Information:
Study ID Numbers: CDR0000069119; ECOG-E1F01
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00028678
Other Adult Glioblastoma Multiforme Studies:
1. Efaproxiral Plus Carmustine in Treating Patients With Progressive or Recurrent Malignant Glioma
2. Combination Chemotherapy in Treating Patients With Recurrent Glioblastoma Multiforme
3. Immunotoxin Therapy in Treating Patients With Malignant Glioma
4. PEG-Interferon alfa-2b With or Without Thalidomide in Treating Patients With Recurrent High-Grade Gliomas
5. Gadolinium Texaphyrin Plus Radiation Therapy in Treating Patients With Supratentorial Glioblastoma Multiforme
Related Studies:
Other adult glioblastoma multiforme Clinical Trials
Other Minnesota Clinical Trials
Other St. Louis Park Clinical Trials
Dalteparin and Radiation Therapy in Treating Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme
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