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

NCT00028678 | Completed Phase 2

• 2 other identifiers: CDR0000069119E1F01
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 12

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.

Conditions

Brain and Central Nervous System Tumors

Keywords

adult glioblastoma; adult giant cell glioblastoma; adult gliosarcoma

Interventions

dalteparin DRUG

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Eastern Cooperative Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (12)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9497, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

CCOP - Kalamazoo

Kalamazoo, Michigan, 49007-3731, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756-0002, United States

Location

CCOP - Oklahoma

Tulsa, Oklahoma, 74136, United States

Location

Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center

Nashville, Tennessee, 37232-6307, United States

Location

CCOP - Scott and White Hospital

Temple, Texas, 76508, United States

Location

CCOP - St. Vincent Hospital Cancer Center, Green Bay

Green Bay, Wisconsin, 54307-3453, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792-0001, United States

Location

Related Publications (1)

• 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.

  PMID: 17882417 RESULT

MeSH Terms

Conditions

Central Nervous System Neoplasms; Glioblastoma; Gliosarcoma

Interventions

Dalteparin; Radiotherapy

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates; Therapeutics

Study Officials

• H. I. Robins, MD, PhD

  University of Wisconsin, Madison

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: January 4, 2002
• First Posted: February 6, 2003
• Study Start: July 11, 2002
• Primary Completion: July 1, 2006
• Study Completion: June 1, 2007
• Last Updated: June 18, 2023

Record last verified: 2023-06

Locations

US (12)