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Phase II Trial Of Poly-ICLC For Glioblastoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

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Trial Information

Phase II Trial Of Poly-ICLC For Glioblastoma


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Michael Prados, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Federal Government

Study ID:

CDR0000258685

NCT ID:

NCT00052715

Start Date:

November 2002

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult glioblastoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Glioblastoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

UCSF Comprehensive Cancer CenterSan Francisco, California  94115