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

Johns Hopkins Medicine

Status and phase

Terminated

Phase 2

Conditions

Brain and Central Nervous System Tumors

Treatments

Drug: poly ICLC

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00052715

NCI-2012-02506 (Registry Identifier)

CDR0000258685 (Registry Identifier)

NABTC-0105

Details and patient eligibility

About

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.

Full 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.

Enrollment

31 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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