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Temozolomide vs. Temozolomide and Thalidomide Treatment in Recurrent Glioblastoma

Primary Purpose

Glioblastoma

Status

Unknown status

Phase

Phase 2

Locations

Switzerland

Study Type

Interventional

Intervention

Temozolomide

Temozolomide plus Thalidomide

About this trial

This is an interventional treatment trial for Glioblastoma focused on measuring recurrent, after standard therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female patients 18 to 70 years
Histologically proven glioblastoma, WHO grade IV
Evidence of tumor recurrence or progression by MRI at least 3 months after radiation treatment
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)
Patient should have received a minimum of 2 cycles of adjuvant chemotherapy with temozolomide after concomitant regime of temozolomide and Radiotherapy
Patient had recovered from the effects of surgery
Karnofsky Performance Status of ≥70
Mini-Mental State Examination score >25
Adequate hepatic function: AST <52 U/l, ALT <50 U/l, AP ≤129 U/l
Adequate hematological values: neutrophils ≥1.5 x 109/l, thrombocytes ≥100 x 109/l
Adequate renal function: clearance <110 μmol/l
Written informed consent before entering the study

Exclusion Criteria:

Other severe underlying diseases
Significant renal, hepatic or bone marrow impairment
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
Known Acquired Immune Deficiency Syndrome (AIDS)
Known hypersensitivity to temozolomide, dacarbazine or thalidomide (or any of the excipients)
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).
Concurrent treatment with other experimental drugs or other anti-cancer therapy; treatment within a clinical trial within 30 days prior to trial entry

Sites / Locations

University Zurich, Departement of Neurosurgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm Description

Temozolomide 75 mg/m2 daily for 21 days during each 28-day cycle until tumor progression.

Temozolomide 200 mg/m2 for 5 days during each 28-day cycle plus Thalidomide 100 mg for 2 weeks, thereafter 200 mg daily continuously until tumor progression.

Outcomes

Primary Outcome Measures

Proportion of patients with progression free survival

Secondary Outcome Measures

Proportion of patients with a clinical response. Time to disease progression. Progression free survival.

Full Information

NCT ID

NCT00521482

First Posted

August 27, 2007

Last Updated

August 27, 2007

Sponsor

University of Zurich

1. Study Identification

Unique Protocol Identification Number

NCT00521482

Brief Title

Temozolomide vs. Temozolomide and Thalidomide Treatment in Recurrent Glioblastoma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2007

Overall Recruitment Status

Unknown status

Study Start Date

September 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

January 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

University of Zurich

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioblastoma

Keywords

recurrent, after standard therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Temozolomide 75 mg/m2 daily for 21 days during each 28-day cycle until tumor progression.

Arm Title

Arm Type

Experimental

Arm Description

Temozolomide 200 mg/m2 for 5 days during each 28-day cycle plus Thalidomide 100 mg for 2 weeks, thereafter 200 mg daily continuously until tumor progression.

Intervention Type

Drug

Intervention Name(s)

Temozolomide

Other Intervention Name(s)

Temodal

Intervention Type

Drug

Intervention Name(s)

Temozolomide plus Thalidomide

Other Intervention Name(s)

Temodal, plus, Myrin

Primary Outcome Measure Information:

Title

Proportion of patients with progression free survival

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Proportion of patients with a clinical response. Time to disease progression. Progression free survival.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female patients 18 to 70 years Histologically proven glioblastoma, WHO grade IV Evidence of tumor recurrence or progression by MRI at least 3 months after radiation treatment 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) Patient should have received a minimum of 2 cycles of adjuvant chemotherapy with temozolomide after concomitant regime of temozolomide and Radiotherapy Patient had recovered from the effects of surgery Karnofsky Performance Status of ≥70 Mini-Mental State Examination score >25 Adequate hepatic function: AST <52 U/l, ALT <50 U/l, AP ≤129 U/l Adequate hematological values: neutrophils ≥1.5 x 109/l, thrombocytes ≥100 x 109/l Adequate renal function: clearance <110 μmol/l Written informed consent before entering the study Exclusion Criteria: Other severe underlying diseases Significant renal, hepatic or bone marrow impairment 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 Known Acquired Immune Deficiency Syndrome (AIDS) Known hypersensitivity to temozolomide, dacarbazine or thalidomide (or any of the excipients) 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). Concurrent treatment with other experimental drugs or other anti-cancer therapy; treatment within a clinical trial within 30 days prior to trial entry

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Miroslava Bjeljac, MD

Phone

0041 44 255 23 96

Miroslava.Bjeljac@usz.ch

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Miroslava Bjeljac, MD

Organizational Affiliation

University of Zurich

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Zurich, Departement of Neurosurgery

City

Zurich

ZIP/Postal Code

8091

Country

Switzerland

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Miroslava Bjeljac, MD

12. IPD Sharing Statement

Learn more about this trial

Temozolomide vs. Temozolomide and Thalidomide Treatment in Recurrent Glioblastoma

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