Overview

A Trial of One-week on/One-week Off Temozolomide Versus Continuous Dose-Intense Temozolomide in Patients With Glioblastoma Multiforme at First Relapse

Status:
Active, not recruiting
Trial end date:
2020-10-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the clinical benefit and safety of two different Dose-Intense temozolomide regimens(one-week on/one-week off regimen versus continuous dose-intense regimen)in patients with glioblastoma at first relapse.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Beijing Sanbo Brain Hospital
Treatments:
Dacarbazine
Temozolomide
Criteria
Inclusion Criteria:

1. Participants must have histopathologically-confirmed, supratentorial, glioblastoma.

2. Participants must have received first-line treatment regimen consisting of RT plus
concomitant temozolomide followed by adjuvant temozolomide.

3. Participants must be first recurrence or progression of glioblastoma after first-line
treatment regimen.

4. Participants must have demonstration of recurrent disease on MRI following prior
therapy.

5. Participants must have bi-dimensionally measurable disease with a minimum measurement
of 1 cm in one dimension on MRI performed within 14 days prior to first treatment. If
receiving corticosteroids, participants must be on a stable or decreasing dose of
corticosteroids for at least 5 days prior to baseline MRI.

6. Participants must have developed progressive disease after receiving prior therapy and
must have an interval of at least 12 weeks from the completion of radiation and
concomitant temozolomide therapy to study entry (unless progressive tumor growth is
outside the radiation field or there is histopathological confirmation of recurrent
tumor)

7. Age 18-75 years old.

8. Life expectancy of at least 12 weeks.

9. Karnofsky performance status at least 60

10. Participants must be able to adhere to the dosing and visit schedules, and agree to
record medication times, concomitant medications, and adverse events (AEs) accurately
and consistently in a daily diary.

11. 20 paraffinsections of glioblastoma tissue must be available.

12. Participants must have normal organ and marrow function as defined below: leukocytes
>4.0×10^9/L,platelets >100×10^9/L,Hemoglobin > 10 g/dl,Serum creatinine< 1.5-fold
upper normal range,AST and ALT <2-fold upper normal range, Alkaline phosphatase <
3-fold upper normal range.

13. Female and male subjects of childbearing potential must agree to use a medically
accepted method of adequate contraception.

Exclusion Criteria:

1. Treatment with any chemotherapy other than temozolomide prior to enrollment.

2. Progressive or recurrent glioblastoma documented by MRI earlier than 12 weeks after
completion of radiotherapy.

3. History of any other cancer.

4. HIV infection.

5. Women who are pregnant or breast feeding.