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

Information source: Eastern Cooperative Oncology Group
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Brain and Central Nervous System Tumors

Intervention: dalteparin (Drug); radiation therapy (Radiation)

Phase: Phase 2

Status: Completed

Sponsored by: Eastern Cooperative Oncology Group

Official(s) and/or principal investigator(s):
H. I. Robins, MD, PhD, Study Chair, Affiliation: University of Wisconsin, Madison

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.

Clinical Details

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

Study design: Primary Purpose: Treatment

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida 33612-9497, United States

CCOP - Carle Cancer Center, Urbana, Illinois 61801, United States

CCOP - Kalamazoo, Kalamazoo, Michigan 49007-3731, United States

West Michigan Cancer Center, Kalamazoo, Michigan 49007, United States

Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States

CCOP - Metro-Minnesota, Saint Louis Park, Minnesota 55416, United States

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire 03756-0002, United States

CCOP - Oklahoma, Tulsa, Oklahoma 74136, United States

Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville, Tennessee 37232-6307, United States

CCOP - Scott and White Hospital, Temple, Texas 76508, United States

CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay, Wisconsin 54307-3453, United States

University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin 53792-0001, United States

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: May 2002
Last updated: January 26, 2010

Page last updated: August 20, 2015

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