Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02661282 : Autologous Cytomegalovirus (CMV)-Specific Cytotoxic T Cells for Glioblastoma (GBM) Patients
PhasePhase 1/Phase 2
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

1. Be willing and able to provide written informed consent for the trial.

2. Be >/= 18 years of age on day of signing informed consent.

3. Have histologically confirmed World Health Organization Grade IV glioma (glioblastoma
or gliosarcoma). Participants will also be eligible if the original histology was
lower grade glioma and there is suspected transformation to glioblastoma based on
imaging findings. If the final pathology report after resection fails to confirm
recurrent glioblastoma or gliosarcoma, the subject will be followed for AEs and
survival, but excluded for other primary and secondary objective analysis. The subject
will be replaced. (Phase II Dose Expansion in Recurrent GBM undergoing resection)

4. Have histologically confirmed World Health Organization Grade IV glioma (glioblastoma
or gliosarcoma). (Phase II Dose Expansion in Newly diagnosed GBM)

5. Be at first relapse. Note: Relapse is defined as progression following initial therapy
(i.e., radiation, chemotherapy, or radiation+chemotherapy). If the participant had a
surgical resection for relapsed disease and no antitumor therapy instituted for up to
12 weeks, this is considered one relapse. For participants who had prior therapy for a
lower grade glioma, the surgical diagnosis of glioblastoma or gliosarcoma will be
considered first relapse. (Phase II Dose Expansion in Recurrent GBM undergoing
resection)

6. Patients must have completed standard radiation therapy with concurrent TMZ within 5
wks of enrollment and must not have evidence of progressive disease on post treatment
imaging.Progression can only be defined using diagnostic imaging if there is new
enhancement outside of the radiation field (beyond the high-dose region or 80% isodose
line) or if there is unequivocal evidence of viable tumor on histopathologic
sampling(e.g.,solid tumor areas[i.e,>70% tumor cell nuclei in areas],high or
progressive increase in MIB-1 proliferation index compared with prior biopsy,or
evidence for histologic progression or increased anaplasia in tumor).Note:Given the
difficulty of differentiating true progression from pseudoprogression,clinical decline
alone,in the absence of radiographic or histologic confirmation of progression,will
not be sufficient for definition of progressive disease in the first 12 weeks after
completion of concurrent chemoradiotherapy.(Ph II Dose Expansion in Newly diagnosed
GBM)

7. Have measurable disease consisting of a minimal volume of 1 cm3. (Phase II Dose
Expansion in Recurrent GBM undergoing resection)

8. CMV seropositive.

9. Be willing to provide tissue from an archival tissue sample or newly obtained core or
excisional biopsy of a tumor lesion. (Phase I and Phase II Dose Expansion in Recurrent
GBM undergoing resection)

10. Be willing to provide tissue from an archival tissue sample. (Phase II Dose Expansion
in Newly diagnosed GBM)

11. Have a performance status of >/= 60 on the KPS.

12. If patient is on steroids, patient must be on a stable or decreasing dose of steroids
for 5 days, no more than 2 mg dexamethasone (or equivalent) total per day at the time
of screening and consent. If on steroids at the time of screening, the dose will need
to be tapered and discontinued at least 5 days prior to CMV T cell infusion.

13. Demonstrate adequate organ function as defined in Inclusion 14.

14. all screening labs should be performed within 14 days (+3 working days) of treatment
initiation. 1) Hematological: Absolute neutrophil count (ANC), >/=1,500 /mcL;
Platelets, >/=100,000 / mcL Hemoglobin, >/= 9 g/dL or >/= 5.6 mmol/L. 2) Renal: Serum
creatinine OR Measured or calculated* creatinine clearance (GFR can also be used in
place of creatinine or CrCl), /=60 mL/min for
subject with creatinine levels > 1.5 X institutional ULN. 3) Hepatic: Serum total
bilirubin, levels > 1.5 ULN; AST (SGOT) and ALT (SGPT), International Normalized Ratio (INR) or Prothrombin Time (PT), Activated Partial
Thromboplastin Time (aPTT), per institutional standard.

15. Female subject of childbearing potential should have a negative urine or serum
pregnancy within 72 hours of study enrollment. If the urine test is positive or cannot
be confirmed as negative, a serum pregnancy test will be required.

16. Female subjects of childbearing potential should be willing to use 2 methods of birth
control during the study and for 30 days after the last dose of the study drug or be
surgically sterile. Subjects of childbearing potential are those who have not been
surgically sterilized or have not been free from menses for > 1 year.

17. Male subjects should agree to use an adequate method of contraception during the
course of the study and for 30 days after the last dose of the study drug.

18. Have histologically confirmed World Health Organization Grade IV glioma (glioblastoma
or gliosarcoma). Participants will be eligible if the original histology was low-grade
glioma and a subsequent histological diagnosis of glioblastoma or variants is made.
(Phase I)

19. A baseline brain MRI must be obtained no more than 14 days (+ 3 working days) prior to
study enrollment. The patient must either be on no steroids or a stable dose of
dexamethasone no greater than 2 mg a day for at least 5 days prior to entrance onto
the study. Patients having undergone recent surgery are eligible as long as they are
at least 3 weeks from resection or 1 week from stereotactic biopsy, and recovering
from any operative or perioperative complications. No measurable disease post
resection will be required. (Phase I)

20. Patients having undergone recent surgery are eligible as long as they are at least 3
weeks from resection or 1 week from stereotactic biopsy, and recovering from any
operative or perioperative complications. No measurable disease post resection will be
required. (Phase I)

21. Any number of prior relapses. (Phase I)

22. A baseline brain MRI must be obtained no more than 14 days (+ 3 working days) prior to
study enrollment. The patient must either be on no steroids or a stable dose of
dexamethasone no greater than 2 mg a day for at least 5 days prior to entrance onto
the study. (Phase II Dose Expansion in Recurrent GBM undergoing resection)

23. A baseline brain MRI obtained no more than 14 days (+ 3 working days) prior to study
enrollment on a stable dose of steroids no greater than 2 mg a day of dexamethasone
for at least 5 days, is required prior to entrance of a patient onto the study.
Patients must be registered on the study within 5 weeks of completion of concurrent
chemoradiation. (Phase II Dose Expansion in Newly diagnosed GBM)

Exclusion Criteria:

1. Has been treated previously with bevacizumab.

2. Has tumor localized primarily to the posterior fossa, spinal cord, or an unresectable
location. (Phase II Dose Expansion in Recurrent GBM undergoing resection)

3. Has received prior interstitial brachytherapy, implanted chemotherapy, or therapeutics
delivered by local injection or convection enhanced delivery. Prior treatment with
Gliadel® wafers will be excluded.

4. Is Expansion in Recurrent GBM undergoing resection)

5. Is currently participating in a study of an investigational agent or using an
investigational device for therapeutic purposes. Concurrent use of Optune® device is
not allowed. (Phase I and Phase II Dose Expansion in Recurrent GBM undergoing
resection)

6. Is currently participating or has participated in any other newly diagnosed
therapeutic trial before or after chemoradiation. (Phase II Dose Expansion in Newly
diagnosed GBM)

7. CMV seronegative.

8. Has a known history of Human Immunodeficiency Virus (HIV) (positive HIV 1/2
antibodies); HTLV1 and/or HTLV2; active Hepatitis B (e.g., HBsAg reactive) or
Hepatitis C (e.g., HCV RNA [qualitative] is detected). Patients with prior HBV
vaccination (anti-HBs positive, HBsAg negative, anti-HBc negative) will NOT be
excluded.

9. Has a diagnosis of immunodeficiency or is receiving systemic immunosuppressive therapy
within 7 days of study entrance.

10. Has had prior chemotherapy, or targeted small molecule therapy, within 2 weeks prior
to study Day 1 or who has not recovered (i.e., adverse events due to a previously administered agent. - Note: Subjects with 2 neuropathy are an exception to this criterion and may qualify for the study. - Note:
If subject received major surgery, they must have recovered adequately from the
toxicity and/or complications from the intervention prior to starting therapy. 12) Has
known gliomatous meningitis, subependymal spread, extracranial disease, or multifocal
disease. (Phase II Dose Expansion in Recurrent GBM undergoing resection)

11. Has a known additional malignancy that is progressing or requires active treatment.
Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the
skin, or in situ cervical cancer that has undergone potentially curative therapy.

12. Has known gliomatous meningitis, subependymal spread, extracranial disease, or
multifocal disease. (Recurrent glioblastoma cohort)

13. Has known gliomatous meningitis, extracranial disease, or multifocal disease. (Phase
II Dose Expansion in Newly diagnosed GBM)

14. Has an active autoimmune disease requiring systemic treatment within the past 3 months
or a documented history of clinically severe autoimmune disease, or a syndrome that
requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or
resolved childhood asthma/atopy would be an exception to this rule. Subjects that
require intermittent use of bronchodilators or local steroid injections would not be
excluded from the study. Subjects with hypothyroidism stable on hormone replacement or
Sjogren's syndrome will not be excluded from the study.

15. Has evidence of interstitial lung disease or active, non-infectious pneumonitis.

16. Has an active infection requiring systemic therapy.

17. Has a history or current evidence of any condition, therapy, or laboratory abnormality
that might confound the results of the trial, interfere with the subject's
participation for the full duration of the trial, or is not in the best interest of
the subject to participate, in the opinion of the treating investigator.

18. Has known psychiatric or substance abuse disorders that would interfere with
cooperation with the requirements of the trial.

19. Is pregnant or breastfeeding, or expecting to conceive or father children within the
projected duration of the trial, starting with the screening visit.

20. Has received prior therapy with any antibody or drug specifically targeting T-cell
co-stimulation or checkpoint pathways. (Phase II Dose Expansion in Recurrent GBM
undergoing resection and in newly diagnosed GBM)

21. Has received a live vaccine within 30 days prior to the first dose of trial treatment.

22. Contraindication for undergoing MRIs.

23. Evidence of bleeding diathesis or use of anticoagulant medication or any medication
that may increase the risk of bleeding that cannot be stopped prior to surgery. (
Phase II Dose Expansion in Recurrent GBM undergoing resection)

24. Tumor localized primarily to the posterior fossa or spinal cord. (Phase I)

25. Has known gliomatous meningitis, subependymal spread, or extracranial disease. (Phase
I)
LinksPermanent Link to THIS page: http://virtualtrials.com/nct/display1trial.cfm?nct=NCT02661282      |      Link to official Clinicaltrials.gov listing
Locations
Houston, Texas
Facility: University of Texas MD Anderson Cancer Center
Investigator:
Contact:
Email not avaialable




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