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.]

NCT03234595 : A Phase I/IIa Study of Cerebraca Wafer Plus Adjuvant Temozolomide (TMZ) in Patients With Recurrent High Grade Glioma
PhasePhase 1/Phase 2
AgesMin: 20 Years Max: N/A
Eligibility
Inclusion Criteria:

1. Female or male, age ? 20 years old

2. Patient has diagnosed recurrent high grade glioma, including anaplastic astrocytoma
and glioblastoma multiforme

3. Patients have enough cavity after glioma resection for planned number of wafer
implantation (by Investigator's judgment)

4. Patients have unilateral single focus of tumor in cerebrum

5. Patients have the 1st time recurrence of glioma

6. Patients undergone standard therapy for their prior glioma episode; for patients with
anaplastic astrocytoma, the prior standard therapy should include surgical resection,
radiation and adjuvant temozolomide (or PCV [procarzine, lomustine and vincristine];
for patients with glioblastoma multiforme the prior standard therapy should include
surgical resection, radiation and adjuvant temozolomide

7. Patients with Karnofsky Performance Score (KPS) ? 60

8. Patients are recovered from toxicities from prior systemic therapies and have adequate
hematopoietic function at screening and before using study medication

- Absolute neutrophil count (ANC) ? 1,000 cells /mm3

- Platelets ? 100,000 /mm3

- Total white blood cell (WBC) ? 2,500 cells /mm3

- Total bilirubin ? 2.5 mg/dL

- AST ? 4 x ULN

- ALT ? 4 x ULN

- ALP ? 5 x ULN

- Creatinine ? 2.0 mg/dL

- GFR ? 30 ml/min/1.73m2

9. Patient with no or mild organ impairment

10. Patients who are eligible and able to participate in the study and accept to enter the
study by signing written informed consent forms

11. Patients agrees not to use food supplementary or dietary that contains Angelica
sinensis after Screening Visit to Day 21

12. All male patients and female patients with child-bearing potential (between puberty
and 2 years after menopause) should use appropriate contraception method(s) for at
least 4 weeks after Cerebraca wafer treatment and TMZ treatment (whichever is longer)
shown below.

- Total abstinence (when this is in line with the preferred and usual lifestyle of
the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal,
post-ovulation methods) and withdrawal are not acceptable methods of
contraception).

- Female sterilization (have had surgical bilateral oophorectomy with or without
hysterectomy) or tubal ligation at least six weeks before taking study treatment.
In case of oophorectomy alone, only when the reproductive status of the woman has
been confirmed by follow up hormone level assessment.

- Male sterilization (at least 6 months prior to screening). For female subjects on
the study, the vasectomized male partner should be the sole partner for that
subject

- Combination of any two of the following (a+b or a+c, or b+c):

1. Use of oral, injected or implanted hormonal methods of contraception or
other forms of hormonal contraception that have comparable efficacy (failure
rate <1%), for example hormone vaginal ring or transdermal hormone
contraception.

2. Placement of an intrauterine device (IUD) or intrauterine system (IUS).

3. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or
cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal
suppository.

Phase IIa The inclusion criteria for Phase IIa is the same as in Phase I except inclusion
criteria #3 3. Patients have cavity after glioma resection greater than 1.5 cm and smaller
than 6 cm in the longest perpendicular diameter.

Exclusion Criteria:

Phase I and IIa

1. Patient who has participated in other investigational studies within 4 weeks prior to
receive Cerebraca wafer

2. Patient with known or suspected hypersensitivity to Cerebraca wafer, TMZ or the
excipient

3. Patient has tumor that cannot be surgically removed without significantly affecting
vital function

4. Patient's glioma locates in the area that is not suitable for Cerebraca wafer
implantation

5. Patient has external-beam radiation therapy within 4 weeks before study entry

6. Patient has other severe and/or life-threatening disease(s) with life expectancy less
than 12 months

7. Patient has immuno-compromised condition, or is with known autoimmune conditions or is
human immunodeficiency virus (HIV) seropositive.

8. Patient with medical, social or psychological factors interfering with compliance of
the study

9. Patient has on-going moderate to severe organ impairment other than study indication
that may confound the efficacy evaluation, safety evaluation or usage of TMZ

10. At Phase I, patient is planning to use strong cytochrome P450 modulator.

11. Female patients are lactating, pregnant, or planned to be pregnant
LinksPermanent Link to THIS page: http://virtualtrials.com/nct/display1trial.cfm?nct=NCT03234595      |      Link to official Clinicaltrials.gov listing
Locations
Hualien City,
Taiwan

Facility: Hualien Tzu Chi Hospital
Investigator:
Contact: Jui-Hao Lee, Ph.D. Phone: +886-3-863-0108
Click HERE to send email to this center




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