Dalteparin and Radiation Therapy in Treating Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00028678
First received: January 4, 2002
Last updated: January 26, 2010
Last verified: January 2010
  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

Resource links provided by NLM:


Further study details as provided by Eastern Cooperative Oncology Group:

Study Start Date: May 2002
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00028678

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
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
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 September 14, 2014