cropped color_logo_with_background.png

Clinical Trial Finder

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

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00028678
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Eastern Cooperative Oncology Group
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 H. I. Robins, MD, PhD
Principal Investigator Affiliation University of Wisconsin, Madison
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Brain and Central Nervous System Tumors
Additional 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Tampa, Florida

Status

Address

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9497

CCOP - Carle Cancer Center, Urbana, Illinois

Status

Address

CCOP - Carle Cancer Center

Urbana, Illinois, 61801

CCOP - Kalamazoo, Kalamazoo, Michigan

Status

Address

CCOP - Kalamazoo

Kalamazoo, Michigan, 49007-3731

West Michigan Cancer Center, Kalamazoo, Michigan

Status

Address

West Michigan Cancer Center

Kalamazoo, Michigan, 49007

Mayo Clinic Cancer Center, Rochester, Minnesota

Status

Address

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905

CCOP - Metro-Minnesota, Saint Louis Park, Minnesota

Status

Address

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416

Lebanon, New Hampshire

Status

Address

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756-0002

CCOP - Oklahoma, Tulsa, Oklahoma

Status

Address

CCOP - Oklahoma

Tulsa, Oklahoma, 74136

Nashville, Tennessee

Status

Address

Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center

Nashville, Tennessee, 37232-6307

CCOP - Scott and White Hospital, Temple, Texas

Status

Address

CCOP - Scott and White Hospital

Temple, Texas, 76508

Green Bay, Wisconsin

Status

Address

CCOP - St. Vincent Hospital Cancer Center, Green Bay

Green Bay, Wisconsin, 54307-3453

Madison, Wisconsin

Status

Address

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792-0001

Powered By