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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00052715
Other study ID # NABTC-0105
Secondary ID CDR0000258685NCI
Status Terminated
Phase Phase 2
First received
Last updated
Start date October 23, 2002
Est. completion date January 1, 2009

Study information

Verified date June 2018
Source Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 31
Est. completion date January 1, 2009
Est. primary completion date February 25, 2006
Accepts healthy volunteers No
Gender All
Age group 18 Years to 120 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
poly ICLC


Locations

Country Name City State
United States UCSF Comprehensive Cancer Center San Francisco California

Sponsors (2)

Lead Sponsor Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Survival in Pts With Newly Diagnosed GBM Overall survival from surgical diagnosis in patients with Newly Diagnosed GBM 2 years
Secondary To Determine 6 Months Progression Free Survival Patients evaluated from date of diagnosis to the 6 month scan 6 months
Secondary Determine the 12-month Survival Rate 12-month survival rate calculated from date of diagnosis 1 year
Secondary to Determine Grade 3 and 4 Toxicities Associated With Poly-ICLC in Newly Diagnosed Patients CTCAE 4 2 years
Secondary 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. 1 year
Secondary To Determine Tumor Response Tumor response to treatment with Poly-ICLC 2 years
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