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

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
dalteparin
radiation therapy
Sponsored by
Eastern Cooperative Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • H. Lee Moffitt Cancer Center and Research Institute
  • CCOP - Carle Cancer Center
  • CCOP - Kalamazoo
  • West Michigan Cancer Center
  • Mayo Clinic Cancer Center
  • CCOP - Metro-Minnesota
  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
  • CCOP - Oklahoma
  • Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
  • CCOP - Scott and White Hospital
  • CCOP - St. Vincent Hospital Cancer Center, Green Bay
  • University of Wisconsin Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 4, 2002
Last Updated
June 14, 2023
Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00028678
Brief Title
Dalteparin and Radiation Therapy in Treating Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme
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 Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
July 11, 2002 (Actual)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
dalteparin
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
H. I. Robins, MD, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Study Chair
Facility Information:
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9497
Country
United States
Facility Name
CCOP - Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
CCOP - Kalamazoo
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007-3731
Country
United States
Facility Name
West Michigan Cancer Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
CCOP - Metro-Minnesota
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0002
Country
United States
Facility Name
CCOP - Oklahoma
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6307
Country
United States
Facility Name
CCOP - Scott and White Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
CCOP - St. Vincent Hospital Cancer Center, Green Bay
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54307-3453
Country
United States
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-0001
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17882417
Citation
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.
Results Reference
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Dalteparin and Radiation Therapy in Treating Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme

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