RENEW: Feasibility of CMV RNA-Pulsed Dendritic Cells Vaccines for the Treatment of Newly Diagnosed Glioblastoma Patients.

  • STATUS
    Recruiting
  • End date
    May 15, 2025
  • participants needed
    10
  • sponsor
    University of Florida
Updated on 15 May 2022
platelet count
sargramostim
karnofsky performance status
neutrophil count
temozolomide
beam radiation

Summary

In prior trials of CMV RNA-pulsed dendritic cell vaccines, there has been a narrow window between surgery and initiation of chemoradiation to enroll patients and perform leukapheresis (to obtain cells needed to generate investigational vaccine). Patients who had started chemoradiation were not eligible to participate.

In this study, the investigators propose to conduct a pilot study to evaluate the ability to generate pp65 full-length LAMP RNA-pulsed DCs in patients who have completed standard external beam radiation and concomitant temozolomide who are receiving adjuvant temozolomide chemotherapy at the time of enrollment.

Description

This pilot study will enroll adult patients with newly diagnosed WHO Grade IV glioma (GBM) who have completed standard of care chemoradiation and are receiving adjuvant temozolomide chemotherapy. Patients will undergo leukapheresis and resume their adjuvant chemotherapy cycles following their treatment plan for 1 to 2 cycles while CMV pp65 RNA-pulsed DCs are generated.

After QA/QC release, study Vaccine #1 will be given at day 22-24 of the TMZ cycle. All patients will receive Td booster (5 Lf) with Vaccine #1 regardless of booster history. Vaccine #2 and #3 will occur at 2-week intervals.

The following TMZ cycle will start about 2 weeks after Vaccine #3. Patients may complete up to 6 to 12 adjuvant cycles every 5 weeks with pp65 full-length RNA-pulsed DCs administered at day 22-24 of each cycle until all available vaccines are exhausted with a maximum of 10 study vaccines or until disease progression (whichever comes first).

Details
Condition Glioblastoma
Treatment Autologous DCs derived from PBMC loaded with RNA encoding the human CMV matrix protein pp65-flLAMP plus GM-CSF
Clinical Study IdentifierNCT04963413
SponsorUniversity of Florida
Last Modified on15 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age ≥ 18 years
Confirmed diagnosis of de novo Glioblastoma (WHO Grade IV glioma) by histopathology or molecular studies. (Secondary GBM not eligible)
The tumor must have a supratentorial component
Patient have completed standard external beam radiation with concomitant temozolomide
(Minimum dose for concomitant radiotherapy is 40 Gy)
Patient must be receiving adjuvant therapy with Temozolomide at time of enrollment
Karnofsky Performance Status (KPS) ≥ 70
Signed informed consent. If the patient's mental status precludes his/her giving informed consent, written informed consent may be given by the legally authorized representative
For females of childbearing potential, negative serum pregnancy test at enrollment
Women of childbearing potential (WOCBP) must be willing to use acceptable contraceptive method to avoid pregnancy throughout the study and for at least 24 weeks after the last dose of study drug
Refer to Appendix B for definition of WOCBP and guidance on acceptable contraceptive
methods
Males with female partners of childbearing potential must agree to practice adequate
contraceptive methods throughout the study and should avoid conceiving children for 24
weeks following the last dose of study drug
Refer to Appendix B for guidance on acceptable contraceptive methods
For patients receiving steroids, daily dose must be < 4 mg
Adequate Bone marrow and organ function as defined below
Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
Platelet count ≥ 100,000 cells/mm3
Hemoglobin ≥ 9 g/dl. (The use of transfusion or other intervention to achieve Hgb
≥ 9 g/dl is acceptable.)
BUN ≤ 25 mg/dl
Creatinine ≤ 1.7 mg/dl
Bilirubin ≤ 2.0 mg/dl
ALT ≤ 5 times institutional upper limits of normal for age
AST ≤ 5 times institutional upper limits of normal for age

Exclusion Criteria

Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease
free for ≥ 3 years
Metastases detected below the tentorium or beyond the cranial vault and leptomeningeal
involvement
Recurrent disease
Multifocal gliomas defined as distinct tumors that do not have overlapping T2/FLAIR
signal
HIV, Hepatitis B, or Hepatitis C seropositive
Known active infection (requiring treatment by antiviral or antibiotic) at time of
enrollment
Immunosuppressive disease
Severe, active co-morbidity, defined as follows
Unstable angina and/or congestive heart failure requiring hospitalization
Transmural myocardial infarction within the last 6 months
Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy at initiation of XRT/TMZ
Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition. The
need to exclude patients with AIDS from this protocol is necessary because the
treatments involved in this protocol may be significantly immunosuppressive
Patients with autoimmune disease requiring medical management with systemic
immunosuppressants
Major medical illnesses or psychiatric impairments that, in the investigator's
opinion, will prevent administration or completion of protocol therapy
Pregnant or lactating women, due to possible adverse effects on the developing fetus
or infant
Women of childbearing potential and men who are sexually active and are unwilling or
unable to use an acceptable method of contraception for the entire study; this
exclusion is necessary because the treatment involved in this study may be
significantly teratogenic
Prior allergic reaction to TMZ, GM-CSF, or Td
Patients who have received an investigational agent within 28 days prior to study
entry
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