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Effect of Cytokine-induced Killer Cells for Advanced Malignant Gliomas

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ClinicalTrials.gov Identifier: NCT02496988
Recruitment Status : Not yet recruiting
First Posted : July 14, 2015
Last Update Posted : July 14, 2015
Sponsor:
Information provided by (Responsible Party):
The First People's Hospital of Changzhou

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.

Condition or disease Intervention/treatment Phase
Cytokine-Induced Killer Cells Advanced Milignant Gliomas Drug: Temozolomide Biological: CIK Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: A Study of CIK in Combination With Temozolomide With and Without Radiation in Adults With Advanced Malignant Gliomas
Study Start Date : July 2015
Estimated Primary Completion Date : July 2028
Estimated Study Completion Date : July 2030

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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

Temozolomide+CIK
Autologous cytokine-induced killer cells were transfer via venous one week after Temozolomide treat
Biological: CIK
The patients received autologous cytokine-induced killer cells transfusion one week after Temozolomide treat




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02496988


Contacts
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Contact: Jingting Jiang, M.D 8651968870978 wcpjjt@163.com

Sponsors and Collaborators
The First People's Hospital of Changzhou

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Responsible Party: The First People's Hospital of Changzhou
ClinicalTrials.gov Identifier: NCT02496988    
Other Study ID Numbers: GLICIK002
First Posted: July 14, 2015    Key Record Dates
Last Update Posted: July 14, 2015
Last Verified: July 2015
Keywords provided by The First People's Hospital of Changzhou:
Cytokine-Induced Killer Cells
Milignant Gliomas
Temozolomide
Additional relevant MeSH terms:
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Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents