Effect of Cytokine-induced Killer Cells for Advanced Malignant Gliomas

NCT02496988 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: GLICIK002
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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 Advanced Malignant Gliomas. The effectiveness and safety of CIK cells for the treatment of Malignant Glioma is also evaluated.

Conditions

Cytokine-Induced Killer Cells; Advanced Milignant Gliomas

Keywords

Cytokine-Induced Killer Cells; Milignant Gliomas; Temozolomide

Outcome Measures

Primary Outcomes (1)

• Overall survival

  5 years

Secondary Outcomes (1)

• Adverse events

  4 weeks

Study Arms (2)

Temozolomide

OTHER

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

Drug: Temozolomide

Temozolomide+CIK

OTHER

Autologous cytokine-induced killer cells were transfer via venous one week after Temozolomide treat

Biological: CIK

Interventions

Temozolomide DRUG

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

Temozolomide

CIK BIOLOGICAL

The patients received autologous cytokine-induced killer cells transfusion one week after Temozolomide treat

Temozolomide+CIK

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First People's Hospital of Changzhou: lead

MeSH Terms

Interventions

Temozolomide

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Jingting Jiang, M.D

CONTACT

8651968870978; wcpjjt@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2015
• First Posted: July 14, 2015
• Study Start: July 1, 2015
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2030
• Last Updated: July 14, 2015

Record last verified: 2015-07