GlioblastomaPhase 2NCT00521482
Temozolomide vs. Temozolomide and Thalidomide Treatment in Recurrent Glioblastoma
A Phase 2 study testing Temozolomide and Temozolomide plus Thalidomide in people with Glioblastoma, run by University of Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Temozolomide and Temozolomide plus Thalidomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2007to Jan 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Zurich, Departement of Neurosurgery
Zurich, 8091
Miroslava Bjeljac, MD
About this study
Official title: Intensive Dose Temozolomide Treatment or Temozolomide With Thalidomide Treatment in Recurrent Glioblastoma After Standard Therapy:a Randomized Phase II Trial
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.
Read the 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.
- Conditions
- Glioblastoma
- Being tested
- Temozolomide, Temozolomide plus Thalidomide
- Keywords
- recurrent, after standard therapy
- Medical subject headings
- Glioblastoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemozolomideDrug
Also called Temodal
Temozolomide plus ThalidomideDrug
Also called Temodal, plus, Myrin
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Temozolomide 75 mg/m2 daily for 21 days during each 28-day cycle until tumor progression. Receives: Drug: Temozolomide |
| B | Experimental | 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. Receives: Drug: Temozolomide plus Thalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with progression free survival
Measured: 6 months
Secondary outcomes (1)
Proportion of patients with a clinical response. Time to disease progression. Progression free survival.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2007 (estimated)
- Study startSep 2007
- Study completionJan 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Investigators
- Miroslava Bjeljac, MD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00521482
- Sponsor's protocol ID
- TMZ/05
- Other IDs
- P04932
- Status last verified
- Aug 2007
- First submitted
- 27 Aug 2007
- Last updated
- 28 Aug 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Dose Temozolomide Treatment or Temozolomide With Thalidomide Treatment in Recurrent Glioblastoma After Standard Therapy:a Randomized Phase II Trial
- ClinicalTrials.gov ID
- NCT00521482
- Acronym / sponsor ID
- TMZ/05
- Conditions
- Glioblastoma
- Keywords
- recurrent, after standard therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Sep 2007
- Study completion
- Jan 2009 (estimated)
- First posted
- 28 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: TemozolomideTemozolomide 75 mg/m2 daily for 21 days during each 28-day cycle until tumor progression. |
| B | Experimental | Drug: Temozolomide plus ThalidomideTemozolomide 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TemozolomideAlso: Temodal | Drug | A |
| Temozolomide plus ThalidomideAlso: Temodal, plus, Myrin | Drug | B |
Primary outcome
Proportion of patients with progression free survival
Time frame: 6 months
1 secondary outcome
Proportion of patients with a clinical response. Time to disease progression. Progression free survival.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miroslava Bjeljac, MD principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Temozolomide and Temozolomide plus Thalidomide in people with Glioblastoma, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miroslava Bjeljac, MD (0041 44 255 23 96, Miroslava.Bjeljac@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with progression free survival (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2007.