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Brain and Central Nervous System TumorsPhase 2NCT00028678

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

A Phase 2 study testing dalteparin and radiation therapy in people with Brain and Central Nervous System Tumors, run by Eastern Cooperative Oncology Group at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Brain and Central Nervous System Tumors
What is being tested?
dalteparin and radiation therapy
Type of treatment
Surgery or procedure
How many people
45 participants
Where
12 sitesUnited States
Study dates
11 Jul 2002to Jun 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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 locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • CCOP - St. Vincent Hospital Cancer Center, Green Bay

    Green Bay, Wisconsin, 54307-3453

  • CCOP - Kalamazoo

    Kalamazoo, Michigan, 49007-3731

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756-0002

  • University of Wisconsin Comprehensive Cancer Center

    Madison, Wisconsin, 53792-0001

  • Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center

    Nashville, Tennessee, 37232-6307

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612-9497

  • CCOP - Scott and White Hospital

    Temple, Texas, 76508

  • CCOP - Oklahoma

    Tulsa, Oklahoma, 74136

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
dalteparin, radiation therapy
Keywords
adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma
Medical subject headings
Central Nervous System Neoplasms, Glioblastoma, Gliosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dalteparinDrug

  • radiation therapyRadiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2003 (estimated)
  2. Study start11 Jul 2002
  3. Primary completionJul 2006
  4. Study completionJun 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00028678
Sponsor's protocol ID
CDR0000069119
Other IDs
E1F01
Status last verified
Jun 2023
First submitted
4 Jan 2002
Last updated
18 Jun 2023
Results posted
No
Data monitoring committee
No

Publications

  • Robins HI, O'Neill A, Gilbert M, Olsen M, Sapiente R, Berkey B, Mehta M. Effect of dalteparin and radiation on survival and thromboembolic events in glioblastoma multiforme: a phase II ECOG trial. Cancer Chemother Pharmacol. 2008 Jul;62(2):227-33. doi: 10.1007/s00280-007-0596-3. Epub 2007 Sep 20.

    PubMed 17882417

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing dalteparin and radiation therapy in people with Brain and Central Nervous System Tumors, run by Eastern Cooperative Oncology Group at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00028678, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.

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