Dendritic Cell Vaccine With Imiquimod for Patients With Malignant Glioma
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|ClinicalTrials.gov Identifier: NCT01792505|
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : April 21, 2017
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Malignant gliomas are very aggressive and among the most common of brain tumors. A diagnosis carries with it a median survival of approximately 24 months. The current standard treatment of surgical resection followed by radiation therapy and chemotherapy has not substantially prolonged survival and even the few treatment options shown to exhibit small increases in survival primarily benefit certain (i.e., young) patient subpopulations.
Cancer vaccines represent one novel therapy for malignant gliomas. The goal is for the body to recognize the tumor cells are foreign and produce its own response to fight off recurring tumor cells. A promising means of causing an immune response so the body can create this immunity is through the use of dendritic cell (DC) vaccines.
|Condition or disease||Intervention/treatment||Phase|
|Malignant Glioma||Biological: Dendritic Cell Vaccine in combination with Imiquimod cream||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||71 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Trial of Surgical Resection Followed by Vaccination With Dendritic Cells Pulsed With Tumor Lysate With Imiquimod for Patients With Malignant Glioma|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||November 14, 2014|
|Actual Study Completion Date :||October 2016|
Biological: Dendritic Cell Vaccine in combination with Imiquimod cream
After a successful complete resection of malignant glioma, patients will receive a total of 3 vaccines, each are 2 weeks apart. Imiquimod cream will be applied prior to and after each vaccination.
- safety of an autologous tumor lysate- loaded dendritic cell (DC) vaccine with Imiquimod cream application [ Time Frame: 1 year ]Safety relative to vaccine will be monitored in terms of Serious Adverse Events according to FDA regulations and recorded on a MedWatch 3500a form. A Data Safety Monitoring Committee will meet every 6 months to review AEs/SAE's. In the event of any subject death within a 30 day period following study agent administration, the DSMC will review the death within that time frame. If two deaths are deemed to be "probably" or "definitely' related to study agent administration, all study agent administrations will be stopped and the FDA and IRB will be notified of study cessation.
- progression free survival of patients after they receive tumor lysate-loaded DC vaccine with Imiquimod cream application. [ Time Frame: 1 year ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Patients must have a histopathological diagnosis of malignant glioma.
- Patients 18 years of age or older.
- Patients must have undergone maximal surgical resection of malignant glioma
- Both male and female of childbearing age entering the protocol must use a medically accepted form of birth control during the study, will be required to have a negative pregnancy test for female.
- Patients must have a Karnofsky performance score of at least 60%.
- Patients must be off steroids for at least two weeks prior to vaccination.
- Baseline hematologic and complete metabolic panel within one week of initiating therapy must fall within normal ranges
- Patient must be capable of signing IRB approved Research Consent and Release of Medical Records form.
- Severe pulmonary, cardiac or other systemic disease associated with an unacceptable anesthetic or operative risk.
- The presence of an acute infection requiring active treatment will be criteria for delay or exclusion.
- Contraindication to MRI procedure unless otherwise determined by PI.
- Patients with a known history of an autoimmune disorder.
- Patients positive for hepatitis B, hepatitis C, HIV I/II, syphilis, HTLV I/II, HCV.
- Patients with allergy to Gentamicin.
- Patient inability to participate as determined by PI discretion.
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): NCT01792505
|United States, California|
|Cedars Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|Principal Investigator:||John Yu, MD||Cedars-Sinai Medical Center|
|Responsible Party:||John Yu, MD, Cedars-Sinai Medical Center|
|Other Study ID Numbers:||
|First Posted:||February 15, 2013 Key Record Dates|
|Last Update Posted:||April 21, 2017|
|Last Verified:||April 2017|
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