Overview

Clinical Trial of the Use of the Nasal Spray of Patients With Recurrence of Glioblastoma

Status:
Withdrawn
Trial end date:
2018-07-17
Target enrollment:
0
Participant gender:
All
Summary
This is a study to determine the efficacy, safety and clinical benefit (how well the drugs works), of the pharmaceutical compositions in Nasal Spray NST-4G for the treatment of brain tumors( Recurrent Glioblastoma, Gliosarcoma,Anaplastic Gliomas, Previously Treated). All drugs target the inhibition of the growth factors and neo-angiogenesis as one the main reasons for the growth of the tumor. The purpose of the Nasal Spray NST-4G study is to determine the safety and tolerability in order to establish the best dose level to be used in future studies.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Center Trials & Treatment
Treatments:
Axitinib
Sunitinib
Criteria
Inclusion Criteria:

1. Has been treated previously with bevacizumab and (or) temozolomide.

2. Be willing and able to provide written informed consent/assent for the trial.

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

4. Have histologically confirmed World Health Organization Grade IV malignant 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.

5. Patients must be at first or second relapse and clinically require reoperation for
tumor progression within 4 to 6 weeks. 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 low grade glioma, the surgical diagnosis of a
high grade glioma will be considered first relapse.

6. Have measurable disease consisting of a minimal volume of 1 cm3.

7. Have provided tissue from an archival tissue sample of a tumor lesion.

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

9. Stable dose of steroids for 5 days, no more than 2 mg dexamethasone (or equivalent)
total per day

10. Demonstrate adequate organ function as defined in Table 1, all screening labs should
be performed within 14 days prior to registration. 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 (ULN) 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.

11. Hepatic: Serum total bilirubin with total bilirubin levels > 1.5 ULN; AST (SGOT) and ALT (SGPT) Coagulation: International Normalized Ratio (INR) or Prothrombin Time (PT) ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within
therapeutic range of intended use of anticoagulants; Activated Partial Thromboplastin
Time (aPTT) PT or PTT is within therapeutic range of intended use of anticoagulants.

12. Female subject of childbearing potential should have a negative serum pregnancy test.

13. Female subjects of childbearing potential should be willing to use 2 methods of birth
control or be surgically sterile, or abstain from heterosexual activity for the course
of the study through 90 days after the last dose of study medication. Subjects of
childbearing potential are those who have not been surgically sterilized or have not
been free from menses for > 1 year.

14. Male subjects should agree to use an adequate method of contraception starting with
the first dose of study therapy through 90 days after the last dose of study therapy.

Exclusion Criteria:

1. Has tumor localized primarily to the brainstem or spinal cord.

2. There are acute or chronic diseases of the maxillary and paranasal sinuses, sphenoid
sinuses, the sinuses of the trellis, early or current traumatic injuries of these
zones, fractures of the nasal septum, congenital malformations of the development of
bone tissue of the latticed bone.

3. Is currently participating in or has participated in a study of an investigational
agent or using an investigational device 4 weeks since last dose of agent
administration.

4. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy > 2 mg of
dexamethasone total per day or any other form of immunosuppressive therapy within 7
days prior to the first dose of trial treatment.

5. Has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not
recovered (i.e., administered more than 4 weeks earlier.

6. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy
within 2 weeks prior to study Day 1 or who has not recovered (i.e., baseline) from adverse events due to a previously administered agent. - Note: Subjects
with alopecia, qualify for the study.

7. 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.

8. Has known carcinomatous meningitis, extracranial disease, or multifocal disease.

9. 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.

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

11. Has an active infection requiring systemic therapy.

12. 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.

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

14. Is pregnant or breastfeeding, or expecting to conceive or father children within the
projected duration of the trial, starting with the screening visit through 90 days
after the last dose of trial treatment.

15. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).

16. Has known history of Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA
[qualitative] is detected).