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Effect of Cytokine-induced Killer Cells for Advanced Malignant Gliomas

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT02496988
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 The First People's Hospital of Changzhou
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Cytokine-Induced Killer Cells, Advanced Milignant Gliomas
Arms & Interventions

Arms

Other: 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

Other: Temozolomide+CIK

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

Interventions

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

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Jingting Jiang, M.D

wcpjjt@163.com

8651968870978

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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