- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00028678
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Florida
-
Tampa, Florida, United States, 33612-9497
- H. Lee Moffitt Cancer Center and Research Institute
-
-
Illinois
-
Urbana, Illinois, United States, 61801
- CCOP - Carle Cancer Center
-
-
Michigan
-
Kalamazoo, Michigan, United States, 49007
- West Michigan Cancer Center
-
Kalamazoo, Michigan, United States, 49007-3731
- CCOP - Kalamazoo
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic Cancer Center
-
Saint Louis Park, Minnesota, United States, 55416
- CCOP - Metro-Minnesota
-
-
New Hampshire
-
Lebanon, New Hampshire, United States, 03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
-
-
Oklahoma
-
Tulsa, Oklahoma, United States, 74136
- CCOP - Oklahoma
-
-
Tennessee
-
Nashville, Tennessee, United States, 37232-6307
- Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
-
-
Texas
-
Temple, Texas, United States, 76508
- CCOP - Scott and White Hospital
-
-
Wisconsin
-
Green Bay, Wisconsin, United States, 54307-3453
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
-
Madison, Wisconsin, United States, 53792-0001
- University of Wisconsin Comprehensive Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: H. I. Robins, MD, PhD, University of Wisconsin, Madison
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Astrocytoma
- Glioma
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Glioblastoma
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Anticoagulants
- Heparin, Low-Molecular-Weight
- Tinzaparin
- Dalteparin
Other Study ID Numbers
- CDR0000069119
- E1F01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Brain and Central Nervous System Tumors
-
Children's Hospital Los AngelesUnknownBrain and Central Nervous System TumorsUnited States, Canada, Australia, Switzerland, New Zealand
-
Emory UniversityNational Cancer Institute (NCI)CompletedBrain and Central Nervous System TumorsUnited States
-
Abramson Cancer Center of the University of PennsylvaniaNational Cancer Institute (NCI)CompletedBrain and Central Nervous System TumorsUnited States
-
Duke UniversityNational Cancer Institute (NCI)CompletedBrain and Central Nervous System TumorsUnited States
-
Duke UniversityNational Cancer Institute (NCI)CompletedBrain and Central Nervous System TumorsUnited States
-
St. Jude Children's Research HospitalCompletedBrain Tumors | Central Nervous System TumorsUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedBrain Tumors | Central Nervous System TumorsUnited States, Australia, Canada
-
University of Colorado, DenverNational Cancer Institute (NCI)CompletedBrain and Central Nervous System TumorsUnited States
-
Pediatric Brain Tumor ConsortiumNational Cancer Institute (NCI)CompletedVNP40101M in Treating Young Patients With Recurrent, Progressive, or Refractory Primary Brain TumorsBrain and Central Nervous System TumorsUnited States
-
New Approaches to Brain Tumor Therapy ConsortiumNational Cancer Institute (NCI)CompletedBrain and Central Nervous System TumorsUnited States
Clinical Trials on radiation therapy
-
NRG OncologyNational Cancer Institute (NCI)RecruitingUnrectable or Locally Recurrent Hepatocellular CarcinomaUnited States
-
University of California, San FranciscoVarian Medical SystemsRecruitingStage IV Anal Cancer AJCC v8 | Metastatic Gastroesophageal Junction Adenocarcinoma | Metastatic Colorectal Carcinoma | Stage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Postneoadjuvant Therapy Stage... and other conditionsUnited States
-
Medical College of WisconsinRecruitingHead and Neck CancerUnited States
-
Medical College of WisconsinRecruitingResectable Head and Neck Squamous Cell CarcinomaUnited States
-
Mayo ClinicNational Cancer Institute (NCI)Completed
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedBrain Tumor | Central Nervous System TumorUnited States, Canada, Australia, Puerto Rico, Switzerland, New Zealand
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedAnn Arbor Stage II Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | Ann Arbor Stage I Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | Extranodal Marginal Zone LymphomaUnited States
-
Changhai HospitalRecruitingLocalized Prostate CancerChina
-
NYU Langone HealthCompletedBreast CancerUnited States
-
Medical College of WisconsinActive, not recruitingHigh-Dose Lymph Node Intensity Modulated Radiation Therapy and Hypofractionated Prostate (SIB) (SIB)Prostate CancerUnited States