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

Sponsor

Eastern Cooperative Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00028678

Collaborator

National Cancer Institute (NCI) (NIH)

Locations

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Brain and Central Nervous System Tumors	Drug: dalteparin Radiation: radiation therapy	Phase 2

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.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

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 Start Date :

May 1, 2002

Actual Primary Completion Date :

Jul 1, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida	United States	33612-9497
2	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
3	CCOP - Kalamazoo	Kalamazoo	Michigan	United States	49007-3731
4	West Michigan Cancer Center	Kalamazoo	Michigan	United States	49007
5	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905
6	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota	United States	55416
7	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756-0002
8	CCOP - Oklahoma	Tulsa	Oklahoma	United States	74136
9	Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center	Nashville	Tennessee	United States	37232-6307
10	CCOP - Scott and White Hospital	Temple	Texas	United States	76508
11	CCOP - St. Vincent Hospital Cancer Center, Green Bay	Green Bay	Wisconsin	United States	54307-3453
12	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin	United States	53792-0001