Effect of Cytokine-induced Killer Cells for Advanced Malignant Gliomas

Launched by THE FIRST PEOPLE'S HOSPITAL OF CHANGZHOU · Jul 13, 2015

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment option for patients with advanced malignant gliomas, a type of brain cancer. The main goal is to see if combining a standard chemotherapy drug called Temozolomide with a special type of immune cell therapy known as cytokine-induced killer cells (CIK) can help patients live longer. Researchers will also check how safe this combined treatment is for patients.

To participate in this study, patients must be at least 18 years old and have a confirmed diagnosis of grade 4 advanced malignant glioma. They should have had no more than three previous treatments for their cancer and must have completed at least one cycle of Temozolomide without serious side effects. Participants will undergo regular monitoring to assess their health and the effectiveness of the treatment. It's important to know that this trial isn't currently recruiting participants, but it's a chance for patients to receive potentially promising therapy while contributing to important research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subjects with documented histologically confirmed primary grade 4 advanced malignant glioma.
• • No more than 3 prior relapses or prior systemic treatments.
• • Recurrent disease documented by MRI after prior therapy.
• * Must have at least one site of bidimensionally measurable disease:
• • archived tissue from the initial diagnosis of advanced malignant glioma or upon transformation to advanced malignant glioma are available for central review within approximately 4 weeks after enrollment.
• • Completed at least one full cycle of temozolomide of 200 mg/m2/day administered on Days 1-5 of a 28-day cycle, without unacceptable toxicity or progression.
• • Karnofsky performance status of 60 or more. Adequate organ and bone marrow function as defined by hematological and serum chemistry limits.
• • At least 18 years old.
• • Both men and women must practice adequate contraception.
• • Informed consent.
• Exclusion Criteria:
• • Progressed while on temozolomide.
• • Evidence of acute intracranial or intratumoral hemorrhage \> Grade 1.
• • Not recovered from the toxic effects of prior therapy.
• • Pregnant or breast feeding.
• • History of diabetes mellitus.
• • Uncontrolled intercurrent illness.
• • Congestive heart failure, unstable angina, or a myocardial infarction within 3 months of entering the study.
• • HIV positive.
• • Diagnosis of another malignancy may exclude subject from study.