Temozolomide vs. Temozolomide and Thalidomide Treatment in Recurrent Glioblastoma

Glioblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00521482
• Other study ID #: TMZ/05
• Secondary ID: P04932
• Status: Not yet recruiting
• Phase: Phase 2
• First received: August 27, 2007
• Last updated: August 27, 2007
• Start date: September 2007
• Est. completion date: January 2009

Study information

• Verified date: August 2007
• Source: University of Zurich
• Contact: Miroslava Bjeljac, MD
• Phone: 0041 44 255 23 96
• Email: Miroslava.Bjeljac[@]usz.ch
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate the efficacy and safety of intensive dose temozolomide treatment alone in parallel to a combination with thalidomide in patients with recurrent glioblastoma after standard therapy.

In the treatment arm A of the study it will be investigated whether or not continuous dosing of temozolomide may overcome alkylator resistance in patients with glioblastoma who progress on the 5/28 day dosing regimen.

For treatment arm B it is postulated that the combination of thalidomide and temozolomide is effective with respect to time to progression and progression-free survival due to the fact that temozolomide and thalidomide have different mechanisms of action.

Description:

• 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Glioblastoma

Intervention

Drug:
• Temozolomide

• Temozolomide plus Thalidomide

Locations

Country	Name	City	State
Switzerland	University Zurich, Departement of Neurosurgery	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with progression free survival		6 months
Secondary	Proportion of patients with a clinical response. Time to disease progression. Progression free survival.