Phase I Study of a Dendritic Cell Vaccine for Patients With Either Newly Diagnosed or Recurrent Glioblastoma
NCT ID: NCT02010606
Last Updated: 2021-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
39 participants
INTERVENTIONAL
2014-01-08
2021-07-10
Brief Summary
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To qualify for this study, patients must have very little to no residual tumor visible on a recent MRI. In addition to the vaccines, patients with newly diagnosed glioblastoma will receive standard temozolomide chemotherapy and radiation therapy. Patients with recurrent glioblastoma will not receive any treatment other than the vaccines as long as they are participating in this study, unless they were previously treated with bevacizumab, in which case they will be allowed to continue receiving bevacizumab.
Detailed Description
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Patients will receive a series of four vaccines given weekly during the Induction phase, followed by vaccinations every 8 weeks during the Maintenance phase for as long as patients remain on the study or until the vaccine supply is depleted. In addition to the investigative treatment, patients with newly diagnosed glioblastoma will receive standard temozolomide chemotherapy and radiation treatment, with the Induction phase beginning at the conclusion of radiation. Patients with recurrent glioblastoma will not receive treatment other than the investigative treatment, unless they were previously treated with bevacizumab, in which case they will be allowed to continue receiving bevacizumab.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort A: Patients with newly diagnosed glioblastoma
Dendritic cell vaccination, in addition to standard temozolomide chemotherapy and involved field radiation therapy
Dendritic cell vaccination, in addition to standard temozolomide chemotherapy and involved field radiation therapy
Patients will receive a series of four vaccines given weekly during the Induction phase, followed by vaccinations every 8 weeks during the Maintenance phase for as long as patients remain on the study or until the vaccine supply is depleted. In addition to the investigative treatment, patients with newly diagnosed glioblastoma will receive standard temozolomide chemotherapy and radiation treatment, with the vaccine Induction phase beginning at the conclusion of radiation.
Cohort B: Patients with recurrent glioblastoma
Dendritic cell vaccination, with optional bevacizumab treatment for patients previously treated with bevacizumab
Dendritic cell vaccination, with optional bevacizumab treatment for patients previously treated with bevacizumab
Patients will receive a series of four vaccines given weekly during the Induction phase, followed by vaccinations every 8 weeks during the Maintenance phase for as long as patients remain on the study or until the vaccine supply is depleted. Patients with recurrent glioblastoma will not receive additional treatment other than the investigative treatment as long as they remain on study, unless they were previously treated with bevacizumab, in which case they will be allowed to continue receiving bevacizumab
Interventions
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Dendritic cell vaccination, in addition to standard temozolomide chemotherapy and involved field radiation therapy
Patients will receive a series of four vaccines given weekly during the Induction phase, followed by vaccinations every 8 weeks during the Maintenance phase for as long as patients remain on the study or until the vaccine supply is depleted. In addition to the investigative treatment, patients with newly diagnosed glioblastoma will receive standard temozolomide chemotherapy and radiation treatment, with the vaccine Induction phase beginning at the conclusion of radiation.
Dendritic cell vaccination, with optional bevacizumab treatment for patients previously treated with bevacizumab
Patients will receive a series of four vaccines given weekly during the Induction phase, followed by vaccinations every 8 weeks during the Maintenance phase for as long as patients remain on the study or until the vaccine supply is depleted. Patients with recurrent glioblastoma will not receive additional treatment other than the investigative treatment as long as they remain on study, unless they were previously treated with bevacizumab, in which case they will be allowed to continue receiving bevacizumab
Eligibility Criteria
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Inclusion Criteria
Cohort B: Glioblastoma up to and including third recurrence To qualify for Cohort B, patients must have previously been treated with involved-field radiation therapy with concurrent temozolomide chemotherapy, and pathology from the resection that qualifies the patient for the trial must be consistent with recurrent disease (ie, patients with predominantly pseudoprogression or radiation necrosis are not eligible). Patients who were initially diagnosed with low-grade glioma (ie, WHO grade 2 glioma) with subsequent progression to high-grade glioma are eligible for Cohort B provided they meet all other eligibility criteria. Patients with recurrent high-grade glioma are eligible up to and including third recurrence, and therefore are permitted to have been treated with up to three distinct chemotherapy regimens prior to trial enrollment. Prior and/or continued bevacizumab therapy is allowed.
2. Complete resection of tumor: gross total resection consisting of no gadolinium enhancement or linear gadolinium enhancement along the resection cavity; or subtotal resection consisting of linear enhancement with nodular gadolinium enhancement of less than 1cm x 1cm x 1cm total volume. The qualifying surgical resection must have been performed at Cedars-Sinai in order to allow for tumor stem cell antigen testing.
3. ≥ 18 years of age
4. Karnofsky Performance Score (KPS) of ≥ 70%
5. Baseline hematologic studies and chemistry profiles must meet the following criteria: hemoglobin (Hgb) \> 9.9 g/dL, absolute neutrophil count (ANC) \> 1000/mm3, platelet count \> 100,000/mm3, blood urea nitrogen (BUN) \< 30 mg/dL, creatinine \< 1.4 mg/dL, alkaline phosphatase (ALP), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 4x upper limit of normal (ULN), prothrombin time (PT) and activated partial thromboplastin time (PTT) ≤ 1.6 x control unless therapeutically warranted
6. Female patients of child bearing potential must have negative serum pregnancy test
7. If not surgically sterile, male and female patients of childbearing age must use double barrier contraception (hormonal; intrauterine device; barrier)
8. Written informed consent, Release of Medical Records Form and HIPAA reviewed and signed by patient or legally authorized representatives
9. Ability to understand and the willingness to sign a written informed consent document.
10. Any Grade 3 or 4 toxicities (according to NCI CTCAE) resolved for at least 2 weeks to Grade 1 or less
Exclusion Criteria
2. Clinically significant pulmonary, cardiac or other systemic disease that, in the opinion of the Investigator, would interfere with the evaluation of vaccine or interpretation of patient safety or study results - for example:
1. New York Heart Association \> Grade 2 congestive heart failure within 6 months prior to study entry;
2. Uncontrolled or significant cardiovascular disease, including:
* Myocardial infarction within 6 months prior to enrollment
* Uncontrolled angina within 6 months
* Diagnosed or suspected congenital long QT syndrome
* Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes);
* Clinically significant abnormality on electrocardiogram (ECG)
3. Pulmonary disease including or greater than grade 2 dyspnea, laryngeal edema, grade 3 pulmonary edema, pulmonary hypertension according to CTCAE 4.03
4. Severe acute or chronic medical or psychiatric condition that could increase the risk associated with trial participation or trial drug administration or could interfere with the interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for entry into the trial. This includes but is not limited to the following: (a) Immunosuppressive disease, (b) Chronic renal disease / failure, (c) Concurrent neurodegenerative disease, (d) Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of the protocol.
5. Presence of an acute infection requiring active treatment with antibiotics/antivirals; prophylactic administration is allowed
6. Active autoimmune disorder or known history of an autoimmune neurologic condition (e.g. Guillain-Barre syndrome). Patients with vitiligo, type 1 diabetes mellitus, hypothyroidism due to autoimmune condition only requiring hormone replacement therapy, psoriasis not requiring systemic therapy, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
7. Known human immunodeficiency virus positivity or acquired immunodeficiency syndrome related illness or other serious medical condition
8. Breastfeeding
9. Received any other therapeutic investigational agent within 30 days of enrollment
10. Contraindication to MRI
11. Foreseeable condition which would preclude the reduction of steroids (dexamethasone) to a maximum of 2 mg BID within a week prior to apheresis.
12. Any foreseeable scheduling constraint that would prevent a patient in Cohort A from starting chemoradiation within 7 weeks of surgery, and any foreseeable scheduling constraint that would prevent a patient in Cohort B from starting the Vaccine Induction Phase within 7 weeks of surgery.
13. Any concomitant chemotherapy other than standard-dose temozolomide for patients in Cohort A; any concomitant chemotherapy for patients in Cohort B, with the exception of the antiangiogenic humanized monoclonal antibody bevacizumab, which is allowed for patients treated with bevacizumab prior to enrollment in the trial.
18 Years
ALL
No
Sponsors
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Cedars-Sinai Medical Center
OTHER
Responsible Party
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Jethro Hu
Faculty Neuro-Oncologist
Principal Investigators
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Jethro Hu, MD
Role: PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center
Locations
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Cedars-Sinai Medical Center
Los Angeles, California, United States
Countries
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References
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Hu JL, Omofoye OA, Rudnick JD, Kim S, Tighiouart M, Phuphanich S, Wang H, Mazer M, Ganaway T, Chu RM, Patil CG, Black KL, Shiao SL, Wang R, Yu JS. A Phase I Study of Autologous Dendritic Cell Vaccine Pulsed with Allogeneic Stem-like Cell Line Lysate in Patients with Newly Diagnosed or Recurrent Glioblastoma. Clin Cancer Res. 2022 Feb 15;28(4):689-696. doi: 10.1158/1078-0432.CCR-21-2867.
Other Identifiers
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33203
Identifier Type: -
Identifier Source: org_study_id