Brain and Central Nervous System Tumors Clinical Trial
— Poly-ICLCOfficial title:
Phase II Trial Of Poly-ICLC For Glioblastoma
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | UCSF Comprehensive Cancer Center | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | National Cancer Institute (NCI) |
United States,
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
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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