Know Cancer

forgot password

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

Phase 2
18 Years
Not Enrolling
Brain and Central Nervous System Tumors

Thank you

Trial Information

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


- 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.

Inclusion Criteria


- Histologically or cytologically confirmed newly diagnosed supratentorial glioblastoma

- 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



- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified


- Platelet count at least 100,000/mm^3

- No history of heparin-induced thrombocytopenia

- No coagulopathy


- 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


- Creatinine no greater than 2.0 mg/dL

- No gross hematuria within the past 6 months


- No uncontrolled hypertension

- No unstable angina

- No symptomatic congestive heart failure

- No myocardial infarction within the past 6 months

- No uncontrolled cardiac arrhythmia


- No peptic ulcer disease within the past 6 months

- Negative stool guaiac

- Negative endoscopy required if positive stool guaiac


- 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


Biologic therapy:

- No concurrent immunomodulators

- No concurrent investigational matrix metalloproteinase inhibitors or antiangiogenesis


- Prior chemotherapy for other malignancy allowed

- No concurrent standard or investigational cytotoxic chemotherapy

Endocrine therapy:

- Not specified


- No prior cranial irradiation

- Prior radiotherapy for other malignancy allowed

- Concurrent radiotherapy allowed


- See Disease Characteristics

- Recovered from prior surgery

- No prior eye or ear surgery


- 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

H. I. Robins, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Wisconsin, Madison


United States: Food and Drug Administration

Study ID:




Start Date:

May 2002

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult glioblastoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Glioblastoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms



Mayo Clinic Cancer Center Rochester, Minnesota  55905
H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
CCOP - Carle Cancer Center Urbana, Illinois  61801
CCOP - Kalamazoo Kalamazoo, Michigan  49007-3731
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
West Michigan Cancer Center Kalamazoo, Michigan  49007-3731
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756-0002
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center Nashville, Tennessee  37232-2516
CCOP - Scott and White Hospital Temple, Texas  76508
CCOP - St. Vincent Hospital Cancer Center, Green Bay Green Bay, Wisconsin  54301
CCOP - Oklahoma Tulsa, Oklahoma  74136