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

NCT ID: NCT00028678

Last Updated: 2023-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-07-11
• Study Completion Date: 2007-06-30

Brief 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.

PURPOSE: Phase II trial to study the effectiveness of combining dalteparin with radiation therapy in treating patients who have newly diagnosed supratentorial glioblastoma multiforme.

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.

Conditions

Brain and Central Nervous System Tumors

Study Design

• Primary Study Purpose: TREATMENT

Interventions

dalteparin

Intervention Type: DRUG

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Eastern Cooperative Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Eastern Cooperative Oncology Group

Principal Investigators

H. I. Robins, MD, PhD

Role: STUDY_CHAIR

University of Wisconsin, Madison

Locations

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

CCOP - Carle Cancer Center

Urbana, Illinois, United States

CCOP - Kalamazoo

Kalamazoo, Michigan, United States

West Michigan Cancer Center

Kalamazoo, Michigan, United States

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, United States

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

CCOP - Oklahoma

Tulsa, Oklahoma, United States

Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center

Nashville, Tennessee, United States

CCOP - Scott and White Hospital

Temple, Texas, United States

CCOP - St. Vincent Hospital Cancer Center, Green Bay

Green Bay, Wisconsin, United States

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 17882417 (View on PubMed)

Other Identifiers

E1F01

Identifier Type: -

Identifier Source: secondary_id

CDR0000069119

Identifier Type: -

Identifier Source: org_study_id