Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT02494804

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Cytokine-Induced Killer Cells Milignant Gliomas

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

CIK

Biological

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

Primary outcomes

  1. Overall survival

    Time frame: 5 years

Secondary outcomes

  1. Adverse events

    Time frame: 4 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Changping Wu, M.D

CONTACT

[email protected]

8651968870978

Sponsors and collaborators

Lead sponsor

The First People's Hospital of Changzhou

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2028
Study completion
2030
First posted
Jul 10, 2015
Registry last updated
Jul 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.