GlioblastomaPhase 3NCT00335075
Efficacy and Safety of Temodal vs Semustine in Subjects With Recurrent Glioblastoma or Anaplastic Astrocytoma (Study P03644)
A Phase 3 study testing Temozolomide and Semustine in people with Glioblastoma and Astrocytoma, run by Merck Sharp & Dohme LLC.
Trial summary
The primary purpose of the study is to evaluate the efficacy and safety of temozolomide compared to semustine in the treatment of patients with glioblastoma multiforme or anaplastic astrocytoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Astrocytoma
- What is being tested?
- Temozolomide and Semustine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- No sites listed yet
- Study dates
- 2 Mar 2005to 23 Feb 2006
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prior histologic confirmation of glioblastoma, anaplastic astrocytoma.
- Evidence of tumor progression or recurrence.
- Age >=18 years.
- Karnofsky performance status >=60%.
- Absolute neutrophil count >=1,500/mm^3, platelet count >=100,000/mm^3, hemoglobin >=8g/dL.
- Serum BUN and creatinine <1.5 times upper normal limit of testing laboratory (ULN).
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- Total bilirubin and direct bilirubin <1.5 times ULN.
- SGOT, SGPT <3 times ULN; alkaline phosphatase <2 times ULN.
- Life expectancy greater than 3 months.
- Informed consent obtained.
- If palliative radiation is needed, agree to give it prior to initiating chemotherapy with study drug. If palliative radiation is required during treatment with study drug, the patient should be permanently discontinued from further treatment with study drug.
- Women of childbearing potential must use a medically accepted, effective method of contraception.
- Women of childbearing potential must have a negative serum pregnancy test 24 hours prior to administration of study drug.
Who cannot join
- Chemotherapy (excluding nitrosourea, mitomycin C or vincristine), biologic therapy or immunotherapy within 4 weeks, inclusive, prior to study drug administration.
- Nitrosourea or mitomycin C administration within 6 weeks, inclusive, prior to study drug administration.
- Vincristine within 2 weeks prior to study drug administration.
- Completion of radiation therapy, interstitial brachytherapy or radiosurgery within 4 weeks prior to study drug administration.
- Surgery within 3 weeks, inclusive, prior to study drug administration.
- Acute infection requiring intravenous antibiotics.
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- Frequent vomiting or medical condition that could interfere with oral medication intake (eg, partial bowel obstruction).
- Previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-situ of the cervix and basal or squamous cell carcinoma of the skin.
- Known HIV positive or AIDS-related illness.
- Pregnant or nursing women.
- Men who are not advised to use an effective method of contraception.
About this study
Official title: A Multicenter, Open-Label, Randomized, Active-Controlled Parallel Groups Study Comparing the Efficacy and Safety of Temodal vs Semustine in the Treatment of Subjects With Recurrent Glioblastoma or Anaplastic Astrocytoma
The primary purpose of the study is to evaluate the efficacy and safety of temozolomide compared to semustine in the treatment of patients with glioblastoma multiforme or anaplastic astrocytoma.
- Conditions
- Glioblastoma, Astrocytoma
- Being tested
- Temozolomide, Semustine
- Medical subject headings
- Glioblastoma, Astrocytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemozolomideDrug
Also called Temodal, Temodar, SCH 052365
Temozolomide orally for 5 consecutive days (Day 1 through Day 5) every 28 days, at a dose of 150 mg/m2/day for subjects previously treated with chemotherapy, or 200 mg/m2/day for subjects who have not received previous chemotherapy.
SemustineDrug
Also called Methyl-CCNU
Semustine orally once every 28 days at a dose of 150 mg/m2/day.
| Study group | Role | What they receive |
|---|---|---|
| Temodal group | Experimental | Subjects treated with temozolomide. Receives: Drug: Temozolomide |
| Semustine group | Active comparator | Subjects treated with semustine. Receives: Drug: Semustine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: 2 months, 3 months, and 6 months
Secondary outcomes (3)
Overall survival
Measured: 6 months
Objective response
Measured: 6 months
Scoring of health-related quality of life
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2006 (estimated)
- Study start2 Mar 2005
- Primary completion23 Feb 2006
- Study completion23 Feb 2006
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 Merck Sharp & Dohme LLCThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00335075
- Sponsor's protocol ID
- P03644
- Status last verified
- May 2017
- First submitted
- 6 Jun 2006
- Last updated
- 15 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Randomized, Active-Controlled Parallel Groups Study Comparing the Efficacy and Safety of Temodal vs Semustine in the Treatment of Subjects With Recurrent Glioblastoma or Anaplastic Astrocytoma
- ClinicalTrials.gov ID
- NCT00335075
- Acronym / sponsor ID
- P03644
- Conditions
- Glioblastoma, Astrocytoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 2 Mar 2005 (actual)
- Primary completion
- 23 Feb 2006 (actual)
- Study completion
- 23 Feb 2006 (actual)
- First posted
- 8 Jun 2006 (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 primary purpose of the study is to evaluate the efficacy and safety of temozolomide compared to semustine in the treatment of patients with glioblastoma multiforme or anaplastic astrocytoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Temodal group | Experimental | Drug: TemozolomideSubjects treated with temozolomide. |
| Semustine group | Active comparator | Drug: SemustineSubjects treated with semustine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Prior histologic confirmation of glioblastoma, anaplastic astrocytoma.
- Evidence of tumor progression or recurrence.
- Age >=18 years.
- Karnofsky performance status >=60%.
- Absolute neutrophil count >=1,500/mm^3, platelet count >=100,000/mm^3, hemoglobin >=8g/dL.
Key exclusion criteria (11 listed)
- Chemotherapy (excluding nitrosourea, mitomycin C or vincristine), biologic therapy or immunotherapy within 4 weeks, inclusive, prior to study drug administration.
- Nitrosourea or mitomycin C administration within 6 weeks, inclusive, prior to study drug administration.
- Vincristine within 2 weeks prior to study drug administration.
- Completion of radiation therapy, interstitial brachytherapy or radiosurgery within 4 weeks prior to study drug administration.
- Surgery within 3 weeks, inclusive, prior to study drug administration.
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, Temodar, SCH 052365Temozolomide orally for 5 consecutive days (Day 1 through Day 5) every 28 days, at a dose of 150 mg/m2/day for subjects previously treated with chemotherapy, or 200 mg/m2/day for subjects who have not received previous chemotherapy. | Drug | Temodal group |
| SemustineAlso: Methyl-CCNUSemustine orally once every 28 days at a dose of 150 mg/m2/day. | Drug | Semustine group |
Primary outcome
Progression-free survival
Time frame: 2 months, 3 months, and 6 months
3 secondary outcomes
Overall survival
Time frame: 6 months
Objective response
Time frame: 6 months
Scoring of health-related quality of life
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Temozolomide and Semustine in people with Glioblastoma and Astrocytoma, run by Merck Sharp & Dohme LLC.
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 13 inclusion and 11 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: finished, as of the sponsor's last update on 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 2 months, 3 months, and 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 15 May 2017.