Thema: Studie: Drug [DCVax(TM)-Brain(elu)] to treat brain cancer
Studie: Drug [DCVax(TM)-Brain(elu)] to treat brain cancer
Tom[a]
22.09.2002 11:23:54
Study of a drug [DCVax(TM)-Brain(elu)] to treat brain cancer
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.
Condition:
Treatment or Intervention Phase Glioblastoma Multiforme
Drug:
Dendritic cell immunotherapy Phase II
Study Type:
Interventional
Study Design:
Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:
A phase II clinical trial evaluating DCVax(TM)-Brain(elu), autologous dendritic cells pulsed with autologous glioblastoma multiforme (GBM) acid-eluted tumor antigens for the treatment of GBM
Further Study 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 mutiforme. 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.
Ages Eligible for Study:
18 Years and above
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.
Expected Total Enrollment: 90
Contact Information:
Donna Speron 001-425-608-3123
Northwest Biotherapeutics, Inc.
Study ID Numbers DC2-GBM(elu), June 2002
Record last reviewed September 2002
NLM Identifier NCT00045968
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.
Condition:
Treatment or Intervention Phase Glioblastoma Multiforme
Drug:
Dendritic cell immunotherapy Phase II
Study Type:
Interventional
Study Design:
Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:
A phase II clinical trial evaluating DCVax(TM)-Brain(elu), autologous dendritic cells pulsed with autologous glioblastoma multiforme (GBM) acid-eluted tumor antigens for the treatment of GBM
Further Study 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 mutiforme. 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.
Ages Eligible for Study:
18 Years and above
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.
Expected Total Enrollment: 90
Contact Information:
Donna Speron 001-425-608-3123
Northwest Biotherapeutics, Inc.
Study ID Numbers DC2-GBM(elu), June 2002
Record last reviewed September 2002
NLM Identifier NCT00045968
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