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

Primary Purpose

Brain and Central Nervous System Tumors

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
poly ICLC
Sponsored by
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCSF Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

poly-ICLC Newly diagnosed GBM

Arm Description

Poly-ICLC 20ug/kg 3 times a week (Monday-Wednesday-Friday) starting one week before Radiation Therapy Intramuscular injection Drug Poly-ICLC

Outcomes

Primary Outcome Measures

Overall Survival in Pts With Newly Diagnosed GBM
Overall survival from surgical diagnosis in patients with Newly Diagnosed GBM

Secondary Outcome Measures

To Determine 6 Months Progression Free Survival
Patients evaluated from date of diagnosis to the 6 month scan
Determine the 12-month Survival Rate
12-month survival rate calculated from date of diagnosis
to Determine Grade 3 and 4 Toxicities Associated With Poly-ICLC in Newly Diagnosed Patients
CTCAE 4
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.
To Determine Tumor Response
Tumor response to treatment with Poly-ICLC

Full Information

First Posted
January 24, 2003
Last Updated
June 22, 2018
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00052715
Brief Title
Biological Therapy and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Acronym
Poly-ICLC
Official Title
Phase II Trial Of Poly-ICLC For Glioblastoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Terminated
Why Stopped
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
Study Start Date
October 23, 2002 (Actual)
Primary Completion Date
February 25, 2006 (Actual)
Study Completion Date
January 1, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
poly-ICLC Newly diagnosed GBM
Arm Type
Experimental
Arm Description
Poly-ICLC 20ug/kg 3 times a week (Monday-Wednesday-Friday) starting one week before Radiation Therapy Intramuscular injection Drug Poly-ICLC
Intervention Type
Drug
Intervention Name(s)
poly ICLC
Primary Outcome Measure Information:
Title
Overall Survival in Pts With Newly Diagnosed GBM
Description
Overall survival from surgical diagnosis in patients with Newly Diagnosed GBM
Time Frame
2 years
Secondary Outcome Measure Information:
Title
To Determine 6 Months Progression Free Survival
Description
Patients evaluated from date of diagnosis to the 6 month scan
Time Frame
6 months
Title
Determine the 12-month Survival Rate
Description
12-month survival rate calculated from date of diagnosis
Time Frame
1 year
Title
to Determine Grade 3 and 4 Toxicities Associated With Poly-ICLC in Newly Diagnosed Patients
Description
CTCAE 4
Time Frame
2 years
Title
To Determine the Change in Neurological Status in Patients With Glioblastoma Treated With External Beam Radiotherapy and Poly-ICLC
Description
Descriptive measure per investigator to describe change in neurological status post-intervention.
Time Frame
1 year
Title
To Determine Tumor Response
Description
Tumor response to treatment with Poly-ICLC
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Prados, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18797818
Citation
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.
Results Reference
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Biological Therapy and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

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