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Intensive Dose Temozolomide Treatment or Temozolomide With Thalidomide Treatment in Recurrent Glioblastoma After Standard Therapy:a Randomized Phase II Trial


Phase 2
18 Years
70 Years
Not Enrolling
Both
Glioblastoma

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Trial Information

Intensive Dose Temozolomide Treatment or Temozolomide With Thalidomide Treatment in Recurrent Glioblastoma After Standard Therapy:a Randomized Phase II Trial


- Primary objectives: To determine the proportion of patients with progression- free
survival after 6 months of intensive dose temozolomide treatment alone or in
combination with thalidomide in patients with recurrent glioblastoma multiforme after
standard therapy.

- Secondary objectives: To assess the effects on tumor growth. To determine the time to
disease progression. To determine the proportion of patients with progression- free
survival. To assess the safety of intensive dose temozolomide treatment alone or in
combination with thalidomide.

- Explorative evaluations: To assess health related Quality of Life. To assess cognitive
functioning. To compare the two treatment arms in terms of efficacy and safety.


Inclusion Criteria:



1. Male or female patients 18 to 70 years

2. Histologically proven glioblastoma, WHO grade IV

3. Evidence of tumor recurrence or progression by MRI at least 3 months after radiation
treatment

4. Prior radiation treatment with 60 Gy in 2-Gy fractions; concurrent daily temozolomide
75 mg/m2 daily for 42 days (max. 49 days); adjuvant temozolomide 150 - 200mg/m2 for 5
days during each 28-day cycle (max. 6 cycles)

5. Patient should have received a minimum of 2 cycles of adjuvant chemotherapy with
temozolomide after concomitant regime of temozolomide and Radiotherapy

6. Patient had recovered from the effects of surgery

7. Karnofsky Performance Status of ≥70

8. Mini-Mental State Examination score >25

9. Adequate hepatic function: AST <52 U/l, ALT <50 U/l, AP ≤129 U/l

10. Adequate hematological values: neutrophils ≥1.5 x 109/l, thrombocytes ≥100 x 109/l

11. Adequate renal function: clearance <110 μmol/l

12. Written informed consent before entering the study

Exclusion Criteria:

1. Other severe underlying diseases

2. Significant renal, hepatic or bone marrow impairment

3. Pregnant women, women who are breast feeding, and women of childbearing potential who
are not using chemical or mechanical contraception (prescription oral contraceptives,
abstinence, condoms with spermicide, surgical sterilization, diaphragm with
spermicide, or intrauterine device) or have a positive pregnancy test

4. Known Acquired Immune Deficiency Syndrome (AIDS)

5. Known hypersensitivity to temozolomide, dacarbazine or thalidomide (or any of the
excipients)

6. Any concomitant drugs contraindicated for use with temozolomide (according to the
product information in the Swiss drug compendium) and thalidomide (investigator's
brochure, international product information).

7. Concurrent treatment with other experimental drugs or other anti-cancer therapy;
treatment within a clinical trial within 30 days prior to trial entry

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of patients with progression free survival

Outcome Time Frame:

6 months

Principal Investigator

Miroslava Bjeljac, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Zurich

Authority:

Switzerland: Swissmedic

Study ID:

TMZ/05

NCT ID:

NCT00521482

Start Date:

September 2007

Completion Date:

January 2009

Related Keywords:

  • Glioblastoma
  • recurrent
  • after standard therapy
  • Glioblastoma

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