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

This study has been terminated.
(prematurely discontinued after results of the EORTC phase-3 study defined the SOC for newly diagnosed GMB pts as RT plus concomitant and adjuvant TMZ)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00052715
First received: January 24, 2003
Last updated: January 26, 2017
Last verified: January 2017
  Purpose

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.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: poly ICLC
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Phase II Trial Of Poly-ICLC For Glioblastoma

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • Overall Survival in Pts With Newly Diagnosed GBM [ Time Frame: total survival from surgical diagnosis ]
    Overall survival from surgical diagnosis in patients with Newly Diagnosed GBM


Secondary Outcome Measures:
  • To Determine 6 Months Progression Free Survival [ Time Frame: 6 months ]
    Patients evaluated from date of diagnosis to the 6 month scan

  • Determine the 12-month Survival Rate [ Time Frame: 1 year ]
    12-month survival rate calculated from date of diagnosis

  • to Determine Grade 3 and 4 Toxicities Associated With Poly-ICLC in Newly Diagnosed Patients [ Time Frame: 2 years ]
    CTCAE 4

  • To Determine the Change in Neurological Status in Patients With Glioblastoma Treated With External Beam Radiotherapy and Poly-ICLC [ Time Frame: 1 year ]
    This was to be a descriptive measure per investigator, however, due to the reports of premature discontinuation of study agent in response to what turned out to be pseudo-progression, that outcome was not assessed.

  • To Determine Tumor Response [ Time Frame: 2 years ]
    Due to the reports of transient enlargement of contrast enhancing disease with subsequent shrinkage during Poly-ICLC treatment and the lack of central radiological review, the protocol defined criteria for radiological response could not be employed because of the risk of inconsistent results


Enrollment: 31
Study Start Date: November 2002
Study Completion Date: December 2009
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00052715

Locations
United States, California
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Michael Prados, MD University of California, San Francisco
  More Information

Publications:
Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00052715     History of Changes
Other Study ID Numbers: NABTC-0105
CDR0000258685 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-2012-02506 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
Study First Received: January 24, 2003
Results First Received: January 26, 2017
Last Updated: January 26, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
adult glioblastoma
adult giant cell glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:
Glioblastoma
Nervous System Neoplasms
Central Nervous System Neoplasms
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Poly ICLC
Poly I-C
Carboxymethylcellulose Sodium
Interferon Inducers
Immunologic Factors
Physiological Effects of Drugs
Laxatives
Gastrointestinal Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on March 28, 2017