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Title An Open-Label Phase 1/2a Dose Escalation Study of Safety and Efficacy of NEO100 in Recurrent Grade IV Glioma

IRB NEONC1315

CC 15-1645

Hospital Main Campus

Stage Recurrent/Relapsed

Phase Phase 1, Phase 2

Disease Brain, Glioma

Drug NEO100

Description

Phase 1:

• Primary Objectives
  • To determine the safety and tolerability of intranasal administration of NEO100 in patients with progressive or recurrent Grade IV gliomas.
  • To identify the maximum tolerated dose (MTD) of NEO100.
  • To assess the progression-free survival rate at six months (PFS-6).

• Secondary Objectives
  • To describe the pharmacokinetics of NEO100 in the serum.
  • To evaluate radiographic response via RANO criteria.

Phase 2a:

• Primary Objectives
  • To further describe the safety and tolerability of intranasal administration of NEO100 in patients with progressive or recurrent Grade IV gliomas.
  • To estimate the progression-free survival rate at six months (PFS-6).

• Secondary Objectives
  • To evaluate the objective response rate as determined by RANO criteria.
  • To assess overall survival.
  • To describe progression-free survival.

Inclusion Criteria

1. Patient must have radiographically-confirmed progression or recurrent Grade IV glioma, and must be on a stable dose of steroid for at least five days.
2. Patient must have failed previous radiation and temozolomide treatment.
3. If progression of disease occurs within three months of conformal radiation, the progression/recurrence must be outside of the radiation field or proven by biopsy/resection.
4. Patient must be of age ≥ 18 years.
5. Patient must have an ECOG performance status of 0-2, or KPS ≥ 60.
6. Patient must have an expected survival of at least three months.
7. Patient must have a baseline MRI with gadolinium within two weeks of entry into the trial.
8. Patient must be willing to provide blood samples for pharmacokinetic study.
9. If patient suffers from seizures, (s)he must be controlled on a stable dose of anti-epileptics for two weeks prior to enrollment.
10. Patient must have adequate organ and marrow function as defined below:
    • Leukocytes ≥ 3,000/microliter
    • Absolute neutrophil count ≥ 1,500/microliter
    • Platelets ≥ 100,000/microliter
    • Total bilirubin within normal institutional limits
    • AST (SGOT)/ALT (SPGT) ≤ 2.5 x institutional upper limit of normal
    • Creatinine within normal institutional limits
11. Female patients of child-bearing potential and male patients must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for 30 days prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a female patient become pregnant, or suspect she is pregnant, while participating in this study, she should inform her treating physician immediately.
    • A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
      • Has not undergone a hysterectomy or bilateral oophorectomy; or
      • Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
    • A negative pregnancy test will be required in all female patients of childbearing potential within seven days of initiating study drug
    • A pregnancy test will be repeated immediately if pregnancy is suspected.
12. Patient must have the ability to understand, and the willingness to sign, a written informed consent.

Exclusion Criteria

1. Patient has completed chemo-radiation within the last three months, unless new contrast enhancement is outside of radiation field, or there is tissue proven recurrence or progression.
2. Patient has had surgery within one week prior to study entry, or chemotherapy within the last four weeks.
3. Patient has not recovered from adverse events due to agents administered more than four weeks earlier.
4. Patient has had prior treatment with bevacizumab, or any other FDAapproved chemotherapy except temozolomide.
5. Patient has had more than one recurrence or progression of their tumors.
6. Patient is receiving any other investigational agents.
7. Patient has a history of allergic reactions attributed to perillyl alcohol.
8. Patient has had prior treatment with perillyl alcohol, administered either intravenously or intranasally.
9. Patient has uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
10. Patient must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
11. Patient has a history of new diagnosis or treatment of cancer other than malignant glioma within five years prior to start of the study, except for basal cell carcinoma or squamous cell carcinoma.
12. Leptomeningeal involvement of the patient's tumor.