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

June 14, 2023 updated by: Eastern Cooperative Oncology Group

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

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

Interventional

Enrollment (Actual)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: H. I. Robins, MD, PhD, University of Wisconsin, Madison

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2002

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

January 4, 2002

First Submitted That Met QC Criteria

February 5, 2003

First Posted (Estimated)

February 6, 2003

Study Record Updates

Last Update Posted (Estimated)

June 16, 2023

Last Update Submitted That Met QC Criteria

June 14, 2023

Last Verified

June 1, 2023

More Information

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

Clinical Trials on radiation therapy

3
Subscribe