Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed 18 and over NCI ECOG-E1F01 NCT00028678, E1F01

Objectives

1. Determine whether dalteparin, initiated at the time of conventional radiotherapy, improves the median survival of patients with newly diagnosed supratentorial glioblastoma multiforme.
2. Determine the time to progression in patients treated with this regimen.
3. Determine the incidence of thromboembolic events in patients treated with this regimen.
4. Determine the feasibility and toxicity of dalteparin in this patient population.

Entry 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

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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Platelet count at least 100,000/mm³
• 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

Expected Enrollment

A total of 72 patients will be accrued for this study.

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.

Robins HI, O'Neill A, Gilbert M, et al.: Effect of dalteparin and radiation on survival and thromboembolic events in glioblastoma multiforme: a phase II ECOG trial. Cancer Chemother Pharmacol 62 (2): 227-33, 2008.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

H. Robins, MD, PhD, Protocol chair		Ph: 608-263-1416; 800-622-8922 Email: hirobins@facstaff.wisc.edu

Registry Information
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
Trial Start Date		2002-05-09
Trial Completion Date		2008-07-15
Registered in ClinicalTrials.gov		NCT00028678
Date Submitted to PDQ		2001-11-01
Information Last Verified		2004-02-11
NCI Grant/Contract Number		CA21115

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