Effect of Cytokine-induced Killer Cells for Stage I-II Malignant Gliomas

Cytokine-Induced Killer Cells Clinical Trial

Official title:

A Study of CIK in Combination With Temozolomide With and Without Radiation in Adults With Stage I-II Malignant Gliomas

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02494804
• Other study ID #: GLICIK001
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: July 8, 2015
• Last updated: July 8, 2015
• Start date: July 2015
• Est. completion date: July 2030

Study information

• Verified date: July 2015
• Source: The First People's Hospital of Changzhou
• Contact: Changping Wu, M.D
• Phone: 8651968870978
• Email: wcpjjt[@]163.com
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Changzhou
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether combining of Temozolomide and cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with Malignant Gliomas. The effectiveness and safety of CIK cells for the treatment of Malignant Glioma is also evaluated.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: July 2030
• Est. primary completion date: July 2028
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

Histologically confirmed intracranial Grade 1 or 2 anaplastic glioma or glioblastoma (astrocytic tumor, anaplastic oligodendroglioma, or oligoastrocytoma).

Received prior standard radiation for a Grade 3 or 4 astrocytic tumor with a minimum cumulative dose of 40 Gy administered.

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cytokine-Induced Killer Cells
• Glioma
• Milignant Gliomas

Intervention

Drug:
• Temozolomide
Capsules supplied in 5-mg, 20-mg, 100-mg, 140-mg, 180-mg, and 250-mg strengths; dosed at 200 mg/m2/day for 5 consecutive days, repeated every 28 days

Biological:
• CIK
The patients received autologous cytokine-induced killer cells transfusion one week after Temozolomide treat

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The First People's Hospital of Changzhou

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		5 years	No
Secondary	Adverse events		4 weeks	Yes