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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
January 24, 2003
January 26, 2017
November 2002
April 2008   (Final data collection date for primary outcome measure)
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
Not Provided
Complete list of historical versions of study NCT00052715 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
Not Provided
Not Provided
 
Biological Therapy and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
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.

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Brain and Central Nervous System Tumors
Drug: poly ICLC
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

Intervention: Drug: poly ICLC
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
31
December 2009
April 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 120 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00052715
NABTC-0105
CDR0000258685 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-2012-02506 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
Yes
Not Provided
Plan to Share IPD: No
Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Michael Prados, MD University of California, San Francisco
Sidney Kimmel Comprehensive Cancer Center
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP