Biological Therapy and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme (Poly-ICLC)

Phase II Trial Of Poly-ICLC For Glioblastoma

RATIONALE: Biological therapies such as poly-ICLC use different ways to stimulate the immune system and stop tumor cells from growing. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining biological therapy with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining poly-ICLC with radiation therapy in treating patients who have newly diagnosed glioblastoma multiforme.

Study Overview

• Status: Terminated
• Conditions: Brain and Central Nervous System Tumors
• Intervention / Treatment: Drug: poly ICLC

Detailed Description

OBJECTIVES:

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

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.

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

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94115
      • UCSF Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Karnofsky 60-100%

Life expectancy

• More than 8 weeks

Hematopoietic

• WBC at least 3,000/mm^3
• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3
• 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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: poly-ICLC Newly diagnosed GBM; Poly-ICLC 20ug/kg 3 times a week (Monday-Wednesday-Friday) starting one week before Radiation Therapy Intramuscular injection Drug Poly-ICLC	Drug: poly ICLC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival in Pts With Newly Diagnosed GBM	Overall survival from surgical diagnosis in patients with Newly Diagnosed GBM	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To Determine 6 Months Progression Free Survival	Patients evaluated from date of diagnosis to the 6 month scan	6 months
Determine the 12-month Survival Rate	12-month survival rate calculated from date of diagnosis	1 year
to Determine Grade 3 and 4 Toxicities Associated With Poly-ICLC in Newly Diagnosed Patients	CTCAE 4	2 years
To Determine the Change in Neurological Status in Patients With Glioblastoma Treated With External Beam Radiotherapy and Poly-ICLC	Descriptive measure per investigator to describe change in neurological status post-intervention.	1 year
To Determine Tumor Response	Tumor response to treatment with Poly-ICLC	2 years

Collaborators and Investigators

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Michael Prados, MD, University of California, San Francisco

Publications and helpful links

General Publications

• Butowski N, Chang SM, Junck L, DeAngelis LM, Abrey L, Fink K, Cloughesy T, Lamborn KR, Salazar AM, Prados MD. 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. 2009 Jan;91(2):175-82. doi: 10.1007/s11060-008-9693-3. Epub 2008 Sep 17.

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2002
• Primary Completion (Actual): February 25, 2006
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: January 24, 2003
• First Submitted That Met QC Criteria: January 26, 2003
• First Posted (Estimate): January 27, 2003

Study Record Updates

• Last Update Posted (Actual): July 18, 2018
• Last Update Submitted That Met QC Criteria: June 22, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: adult glioblastoma; adult giant cell glioblastoma; adult gliosarcoma
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma; Nervous System Neoplasms; Central Nervous System Neoplasms; Physiological Effects of Drugs; Immunologic Factors; Interferon Inducers; Poly ICLC
• Other Study ID Numbers: NABTC-0105; CDR0000258685 (Registry Identifier: PDQ (Physician Data Query)); NCI-2012-02506 (Registry Identifier: CTRP (Clinical Trials Reporting System))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO