Overview

Neoadjuvant Chemoradiation for Resectable Glioblastoma

Status:
Recruiting
Trial end date:
2023-12-31
Target enrollment:
0
Participant gender:
All
Summary
Preoperative therapy has not been well studied in resectable glioblastoma. This study attempts to prospectively assess the feasibility and efficacy of preoperative chemo radiation in improving local control, as this is the predominant mode of failure in these patients leading to poor outcomes. This Phase II study design would be used to proceed with the study treatment after meeting pre-specified events in the initial phase, with goal being to determine whether the new treatment paradigm is sufficiently promising to warrant a major controlled clinical evaluation against the standard therapy.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Geisinger Clinic
Treatments:
Benzolamide
Temozolomide
Criteria
Inclusion Criteria:

1. Newly diagnosed GBM with histopathological confirmation.

2. Surgically suitable for subtotal or gross total resection as determined by central
review.

3. Karnofsky Performance Status (KPS)>70

4. No contraindication for chemoradiation.

5. Complete blood count (CBC)/differential obtained within 28 days prior to registration,
with adequate bone marrow function defined as follows:

1. Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3;

2. Platelets ≥ 100,000 cells/mm3;

3. Hemoglobin ≥ 8.0 g/dl (Note: the use of transfusion or other intervention to
achieve Hgb ≥8.0 g/dl is acceptable)

6. Adequate hepatic function within 28 days prior to registration, as defined below:

1. Alanine Aminotransferase (ALT) and Aspartate transaminase (AST) ≤ 3 x ULN

2. Bilirubin ≤ 1.5 upper limit of normal (ULN)

7. Negative serum pregnancy test obtained for females of child-bearing potential within
28 days prior to step 2 registration.

8. Ability to get multiplanar contrast enhanced Magnetic Resonance Imaging (MRI)

Exclusion Criteria:

1. Recurrent, unresectable or multifocal malignant gliomas.

2. Any site of distant disease (for example, drop metastases from the GBM tumor site)

3. Prior radiation or chemotherapy or radiosensitizers for cancers of the brain and head
and neck region; note that prior chemotherapy for a different cancer is allowable
(except temozolomide).

4. Pregnancy or women of childbearing potential and men who are sexually active and not
willing/able to use medically acceptable forms of contraception; this exclusion is
necessary because the treatment involved in this study may be significantly
teratogenic.

5. Patents treated on any other therapeutic clinical protocols within 30 days prior to
registration.

6. Inability to undergo MRI (e.g., due to safety reasons, such as presence of a
pacemaker, or severe claustrophobia).

7. Severe, active co-morbidity, defined as follows:

1. Transmural myocardial infarction within the last 6 months prior to registration

2. History of recent myocardial infarction 1month prior

3. New York Heart Association grade II or greater congestive heart failure requiring
hospitalization within 3 months prior to registration.

4. Serious or non-healing wound, ulcer or bone fracture or history of abdominal
fistula, intra-abdominal abscess requiring major surgical procedure, open biopsy
or significant traumatic injury within 28 days prior to registration, with the
exception of the craniotomy for surgical resection

5. Acute bacterial or fungal infection requiring intravenous antibiotics at the time
of registration

6. Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects;
note, however, that laboratory tests for coagulation parameters are not required
for entry into this protocol.

7. Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy at the time of registration

8. Acquired immune deficiency syndrome (AIDS) based upon current Center for Disease
Control (CDC) definition; note, however, that HIV testing is not required for
entry into this protocol. The need to exclude patients with AIDS from this
protocol is because the treatments involved in this protocol may be significantly
immunosuppressive with potentially fatal outcomes in patients already
immunosuppressed.

9. Any other severe immuno-compromised condition.

10. Active connective tissue disorders, such as lupus or scleroderma that in the
opinion of the treating physician may put the patient at high risk for radiation
toxicity.

11. End-stage renal disease (i.e. on dialysis or dialysis has been recommended).

12. Any other major medical illnesses or psychiatric treatments that in the
investigator's opinion will prevent administration or completion of protocol
therapy.