GliomaPhase 2NCT00392171

The Effects of Continuous 28-day (28/28) Temozolomide Chemotherapy in Subjects With Recurrent Malignant Glioma Who Have Failed the Conventional 5-day (5/28) Treatment (P04601)

A Phase 2 study testing Temozolomide in people with Glioma and Astrocytoma, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this non-randomized, open-label, multicenter, Phase II, 2-stage design, RESCUE study is to test the hypothesis that continuous 28-day oral dosing (28/28) with dose-intense temozolomide (50 mg/m^2) for up to 12 months may overcome resistance and be effective in the management of adult patients with… Read more about this study

Who is it for?: Ages 19 to 70 years
Conditions the study is for: Glioma, Astrocytoma, Oligodendroglioma
What is being tested?: Temozolomide
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: No sites listed yet
Study dates: 9 Jun 2006to 15 Sep 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 19 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult patients, greater than 18 years old.
Surgically confirmed diagnosis of malignant glioma, specifically anaplastic glioma (anaplastic astrocytoma [AA], anaplastic oligodendroglioma [AO], anaplastic oligoastrocytoma [AOA]) or glioblastoma multiforme (GBM).
Must have completed at least 2 cycles (2 months) of conventional 5/28 temozolomide, with radiological evidence of progression.
GBM treated with concurrent chemoradiation with temozolomide according to the EORTC/NCIC (European Organization for Research \& Treatment of Cancer/National Cancer Institute of Canada) protocol.
Evidence of progression confirmed radiologically (CT [computed tomography] or MRI [magnetic resonance imaging]).
Patients must be enrolled within 2 weeks of last radiological confirmation of progression, except for patients undergoing surgical resection.

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Patients undergoing surgical resection for recurrent disease must be enrolled within 2 weeks of the post-surgical scan.
Patients with no residual disease after surgery are allowed.
Steroids dose should have been stabilized during the last 2 weeks prior to enrollment.
Use of medically approved contraception in fertile males and females.
Women of childbearing potential must have a negative urine or serum pregnancy test (urinary excretion or serum level of bHCG [beta human chorionic gonadotropin]) within 24 hours of inclusion in the study.
Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
Signed informed consent form.

Who cannot join

GBM progression during the first 2 months of adjuvant temozolomide (5/28).
AA progression during the first 2 months of standard temozolomide therapy (5/28).
Chemotherapy for the malignant glioma other than temozolomide.
More than one prior course of chemotherapy with temozolomide.
Patient evolving from anaplastic glioma to GBM following primary therapy.
Patient older than 70 years or who received no conventional chemoradiation regimen.

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Patient who received radiotherapy for recurrent disease.
Patient with metastatic disease.
Known human immunodeficiency virus (HIV) infection.
History of non-compliance to other therapies.
Inadequate hematological, renal and hepatic function according to all of the following laboratory values (to be performed within 14 days, inclusive, prior to study inclusion):
Absolute neutrophil count <=1.5 ×10^9/L;
Platelets <=100 ×10^9/L;
Hemoglobin <90 g/L;
Serum creatinine >=1.5 times upper limit of laboratory normal (ULN);
Total serum bilirubin >=1.5 times ULN;
ASAT (AST [aspartate aminotransferase]) or ALAT (ALT [alanine aminotransferase) >2.0 times ULN;
Alkaline phosphatase of >2.5 times ULN.
Known chronic hepatitis B or hepatitis C infection.
Any other serious medical condition, according to the medical judgment of the physician prior to inclusion in the study.
Any medical condition that could interfere with oral medication intake (e.g., frequent vomiting, partial bowel obstruction).
Other malignancies during the previous 5 years with the exception of surgically cured carcinoma in-situ of the cervix and basal cell carcinoma or non-melanoma skin cancer.
Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule as discussed with the patient before inclusion in the study.

About this study

Official title: The Temozolomide RESCUE Study: A Phase II Trial of Continuous (28/28) Dose-intense Temozolomide (CDIT) Chemotherapy After Progression on Conventional 5/28 Day Temozolomide in Patients With Recurrent Malignant Glioma

Conditions: Glioma, Astrocytoma, Oligodendroglioma, Glioblastoma
Being tested: Temozolomide
Medical subject headings: Glioma, Astrocytoma, Oligodendroglioma, Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TemozolomideDrug
Also called SCH 52365
Subjects will receive temozolomide 50 mg/m^2 for cycles of 28 days for 12 months or until progression

Study groups in NCT00392171
Study group	Role	What they receive
Temozolomide	Experimental	Temozolomide will be administered at a dose of 50 mg/m^2 for cycles of 28 days for 12 months or until progression. Receives: Drug: Temozolomide

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants Surviving at Six Months of Treatment Without Evidence of Disease Progression.
Progression-free survival as determined by Kaplan-Meier method.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Jun 200615 Sep 2009

First posted25 Oct 2006 (estimated)
Study start9 Jun 2006
Primary completion15 Sep 2009
Study completion15 Sep 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for GliomaStudies 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 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00392171
Sponsor's protocol ID: P04601
Status last verified: May 2017
First submitted: 24 Oct 2006
Last updated: 7 Jun 2017
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php

Publications

Perry JR, Belanger K, Mason WP, Fulton D, Kavan P, Easaw J, Shields C, Kirby S, Macdonald DR, Eisenstat DD, Thiessen B, Forsyth P, Pouliot JF. Phase II trial of continuous dose-intense temozolomide in recurrent malignant glioma: RESCUE study. J Clin Oncol. 2010 Apr 20;28(12):2051-7. doi: 10.1200/JCO.2009.26.5520. Epub 2010 Mar 22.
PubMed 20308655

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma
Low Grade Astrocytoma, Low Grade Glioma
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma

All Glioma trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Temozolomide RESCUE Study: A Phase II Trial of Continuous (28/28) Dose-intense Temozolomide (CDIT) Chemotherapy After Progression on Conventional 5/28 Day Temozolomide in Patients With Recurrent Malignant Glioma
ClinicalTrials.gov ID: NCT00392171
Acronym / sponsor ID: P04601
Conditions: Glioma, Astrocytoma, Oligodendroglioma, Glioblastoma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 9 Jun 2006 (actual)
Primary completion: 15 Sep 2009 (actual)
Study completion: 15 Sep 2009 (actual)
First posted: 25 Oct 2006 (estimated)
Results: Posted 17 May 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Temozolomide	Experimental	Drug: TemozolomideTemozolomide will be administered at a dose of 50 mg/m^2 for cycles of 28 days for 12 months or until progression.

Who may qualify

Ages: 19 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Adult patients, greater than 18 years old.
Surgically confirmed diagnosis of malignant glioma, specifically anaplastic glioma (anaplastic astrocytoma [AA], anaplastic oligodendroglioma [AO], anaplastic oligoastrocytoma [AOA]) or glioblastoma multiforme (GBM).
Must have completed at least 2 cycles (2 months) of conventional 5/28 temozolomide, with radiological evidence of progression.
GBM treated with concurrent chemoradiation with temozolomide according to the EORTC/NCIC (European Organization for Research \& Treatment of Cancer/National Cancer Institute of Canada) protocol.
Evidence of progression confirmed radiologically (CT [computed tomography] or MRI [magnetic resonance imaging]).

Key exclusion criteria (23 listed)

GBM progression during the first 2 months of adjuvant temozolomide (5/28).
AA progression during the first 2 months of standard temozolomide therapy (5/28).
Chemotherapy for the malignant glioma other than temozolomide.
More than one prior course of chemotherapy with temozolomide.
Patient evolving from anaplastic glioma to GBM following primary therapy.

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: SCH 52365Subjects will receive temozolomide 50 mg/m^2 for cycles of 28 days for 12 months or until progression	Drug	Temozolomide

Primary outcome

Percentage of Participants Surviving at Six Months of Treatment Without Evidence of Disease Progression.
Time frame: 6 months
Progression-free survival as determined by Kaplan-Meier method.

Results and safety

Results posted to the registry on 17 May 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Temozolomide	120	15

Primary outcome: Percentage of Participants Surviving at Six Months of Treatment Without Evidence of Disease Progression.

Time frame: 6 months. Number. Unit: Percentage of Participants

Measure	Temozolomide n = 116
Anaplastic Glioma (n=28)	35.7
Early Glioblastoma Multiforme (GBM) (n=33)	27.3
Extended Glioblastoma Multiforme (GBM) (n=27)	7.4
Rechallenge Glioblastoma Multiforme (GBM) (n=28)	35.7

Population analysed: Participants who received allocated intervention. The percentage of participants reported is based on the number of participants within each category (not total number of all categories combined).

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Temozolomide	27 of 120 (22.5%)	111 of 120 (92.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20308655Perry JR, Belanger K, Mason WP, Fulton D, Kavan P, Easaw J, Shields C, Kirby S, Macdonald DR, Eisenstat DD, Thiessen B, Forsyth P, Pouliot JF. Phase II trial of continuous dose-intense temozolomide in recurrent malignant glioma: RESCUE study. J Clin Oncol. 2010 Apr 20;28(12):2051-7. doi: 10.1200/JCO.2009.26.5520. Epub 2010 Mar 22.
Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

Related trials for Glioma

Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma
Low Grade Astrocytoma, Low Grade Glioma
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma

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 2 study testing Temozolomide in people with Glioma 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 23 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 7 Jun 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 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?

Yes. Results are posted in the registry (first posted 17 May 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants Surviving at Six Months of Treatment Without Evidence of Disease Progression. (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00392171, which also lists 1 linked publication.

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 7 Jun 2017.