Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Biological Therapy and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	NABTC-0105 NCT00052715, NABTC-01-05

Objectives

1. Determine the efficacy of poly ICLC and radiotherapy, in terms of total survival from date of diagnosis, in patients with newly diagnosed glioblastoma multiforme.
2. Determine the safety and toxicity profile of this regimen in these patients.
3. Determine the 12-month survival rate in patients treated with this regimen.
4. Assess progression-free survival at 6 months and median progression-free survival from date of diagnosis of patients treated with this regimen.
5. Assess response in patients treated with this regimen.
6. Assess changes in neurological status in patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• Histologically confirmed intracranial glioblastoma multiforme (GBM) or gliosarcoma by biopsy or resection within the past 28 days

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• No prior polifeprosan 20 with carmustine implant (Gliadel wafer)
• No concurrent chemotherapy

Endocrine therapy

• Concurrent corticosteroids to treat symptoms or prevent complications are allowed

Radiotherapy

• No prior radiotherapy to the brain
• No concurrent stereotactic radiosurgery
• No concurrent brachytherapy

Surgery

• See Disease Characteristics

Other

• No prior cytotoxic or noncytotoxic drug therapy for GBM
• No prior experimental drug therapy for GBM
• No other concurrent cytotoxic or noncytotoxic drug therapy for GBM
• Concurrent analgesics, antiepileptics, or other drugs to treat symptoms or prevent complications are allowed

Patient Characteristics:

Age

• 18 and over

Performance status

• Karnofsky 60-100%

Life expectancy

• More than 8 weeks

Hematopoietic

• WBC at least 3,000/mm³
• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³
• Hemoglobin at least 10 g/dL (transfusion allowed)

Hepatic

• Bilirubin less than 2 times upper limit of normal (ULN)
• SGOT less than 2 times ULN

Renal

• Creatinine less than 1.5 mg/dL

Other

• No significant medical illness that cannot be controlled adequately with appropriate therapy or that would compromise tolerability of study therapy
• No other cancer (except nonmelanoma skin cancer or carcinoma in situ of the cervix) unless in complete remission and off all therapy for that disease for at least 3 years
• No active infection
• No disease that would obscure toxicity or dangerously alter drug metabolism
• No other serious concurrent medical illness
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

Expected Enrollment

A total of 60 patients will be accrued for this study within 2 years.

Outline

This is a multicenter study.

Within 1-4 weeks after surgery, patients receive poly ICLC intramuscularly 3 times weekly (on days 1, 3, and 5). Treatment continues in the absence of disease progression or unacceptable toxicity.

One week after the initiation of poly ICLC, patients undergo external beam radiotherapy once daily 5 days a week for 6 weeks.

Patients are followed monthly for 1 year and then every 3 months thereafter.

Butowski N, Chang SM, Junck L, et al.: A phase II clinical trial of poly-ICLC with radiation for adult patients with newly diagnosed supratentorial glioblastoma: a North American Brain Tumor Consortium (NABTC01-05). J Neurooncol 91 (2): 175-82, 2009.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

North American Brain Tumor Consortium

Michael Prados, MD, Principal investigator		Ph: 415-353-2966; 800-888-8664 Email: pradosm@neurosurg.ucsf.edu

Registry Information
Official Title		Phase II Trial Of Poly-ICLC For Glioblastoma
Trial Start Date		2002-11-19
Trial Completion Date		2008-04-23
Registered in ClinicalTrials.gov		NCT00052715 1
Date Submitted to PDQ		2002-10-23
Information Last Verified		2005-03-01
NCI Grant/Contract Number		CA62399

Table of Links

1	http://clinicaltrials.gov/ct/show/NCT00052715