Clinical trial NCT00052715: Biological Therapy and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Official title: Phase II Trial Of Poly-ICLC For Glioblastoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Brain and Central Nervous System Tumors
Keywords: adult glioblastoma
adult giant cell glioblastoma
adult gliosarcoma
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Overall Survival in Pts With Newly Diagnosed GBM
timeFrame: 2 years
Secondary outcomes:
measure: To Determine 6 Months Progression Free Survival
timeFrame: 6 months
measure: Determine the 12-month Survival Rate
timeFrame: 1 year
measure: to Determine Grade 3 and 4 Toxicities Associated With Poly-ICLC in Newly Diagnosed Patients
timeFrame: 2 years
measure: To Determine the Change in Neurological Status in Patients With Glioblastoma Treated With External Beam Radiotherapy and Poly-ICLC
timeFrame: 1 year
measure: To Determine Tumor Response
timeFrame: 2 years
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Michael Prados, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.