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Study of a drug [DCVax(TM)-Brain(elu)] to treat brain cancer



Study of a drug [DCVax(TM)-Brain(elu)] to treat brain cancer

For Condition: Glioblastoma Multiforme
Status: Suspended
Sponsor(s): Northwest Biotherapeutics ,
Synopsis: The purpose of the study is to determine the safety and efficacy of an investigational therapy called DCVax(TM)-Brain(elu) in patients with GBM after surgical resection and radiation therapy.
Details: This Phase II trial is designed to evaluate the safety, clinical response and survival of study subjects following treatment with DCVax(TM)-Brain(elu), an immunotherapy intervention for glioblastoma multiforme. The experimental therapy uses a patient's own white blood cells and "teaches" the cells to recognize brain cancer cells. This may help the immune system destroy brain cancer cells. Side effects reported from the Phase I trial include skin reactions of redness, pain & swelling at the injection site, nausea/vomiting, headache & fatigue, diarrhea & low-grade fever. Full details on this Phase II clinical trial are available in the informed consent.
Eligibility:
Study Type:  Interventional, Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - Eighteen (18) years or older. - Newly diagnosed GBM or recurrent brain tumor now with GBM that have not received radiation or chemotherapy. - Surgically resectable tumor; histologically verified GBM. - Must complete radiation therapy 2 weeks prior to experimental therapy. - Karnofsky performance score (KPS) of >60. - No antitumor drug therapies until 4 wks after 3rd and last injection of DCVax(TM)-Brain(elu). - Adequate hematological, hepatic and renal function. - No history of prior malignancy. Exclusion Criteria - Rapid disease progression between surgical resection and baseline. - History of immunodeficiency or autoimmune disease; positive HIV, HbsAg or anti-HCV. - Any medication that might affect immune function. (Exceptions: Nonprescription doses of NSAIDS; acetaminophen or aspirin; low doses of antihistamine therapy; normal range doses of vitamins; and H2 blockers). - Previous cytotoxic or non-cytotoxic drug therapies. - Acute infection within 7 days prior to study treatment. - Pregnant or lactating females. - Unstable or severe intercurrent medical conditions. - Subjects with organ allografts or any underlying conditions that contraindicate DCVax(TM)-Brain(elu) treatment. - Inability to obtain informed consent because of psychiatric or medical problems.
Total Enrollment: 90

Location and Contact Information:


Additional Information:
Study ID Numbers:  DC2-GBM(elu), June 2002; 
Study Start Date: 
Record last reviewed: November 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00045968

Other Glioblastoma Multiforme Studies:
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2. Phase I/II Evaluation of Temozolomide and ZARNESTRA (R115777) for Recurrent and Progressive Glioblastoma Multiforme

3. Study of Therapy with TransMIDTM Compared to Best Standard of Care in Patients with Glioblastoma Multiforme

4. Imaging Study of the Distribution of IL13-PE38QQR Infused Before and After Surgery in Adult Patients with Recurrent Malignant Glioma

5. Interstitial Infusion of IL13-PE38QQR Cytotoxin in Recurrent Malignant Glioma

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