Recurrent Glioblastoma MultiformePhase 2NCT01737346
Procarbazine and Lomustine in Recurrent Glioblastoma
A Phase 2 study testing lomustine and procarbazine in people with Recurrent Glioblastoma Multiforme, run by Incheon St.Mary's Hospital at 1 site in South Korea.
Trial summary
The combination therapy of temozolomide and radiation has been established as the standard therapy for the initial treatment of glioblastoma. However, the prognosis for patients with recurrent/ refractory glioblastoma is dismal, with a median survival of 3~6 months. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Recurrent Glioblastoma Multiforme
- What is being tested?
- lomustine and procarbazine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2012to Apr 2014
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or radiologically confirmed progressive or recurrent glioblastoma with methylated MGMT promoter
- Within 6 months after or during Stupp regimen (TMZ-RT CCRT + adjuvant TMZ), or After re-treatment of cyclic TMZ, 6 months later after Stupp regimen
- KPS ≥ 60%
- Age ≥ 20 years
- At least two weeks apart from prior surgery and prior chemotherapy
- Adequate hematologic, liver, and renal functions
- Unstained slides for central pathology review
- Signed informed consent
Who cannot join
- Prior malignancy within 5 years except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and carcinoma in situ of the cervix
- maternity or breastfeeding
- Evidence of active infection within 2 weeks prior to study
- Previous treatment with procarbazine and/or CCNU
- Evidence of leptomeningeal metastasis
- Unable to comply with the study protocol
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Ajou University Hospital
Wonchondong, Suwon, 443-721
Se-Hyuk Kim, Doctor, 82-31-219-5235, nsksh@ajou.ac.kr
Se-Hyuk Kim, Doctor
About this study
Official title: Phase 2 Clinical Trial of PC(Procarbazine-CCNU) Chemotherapy in Patients With Recurrent or Resistant Glioblastoma With Methylated MGMT
The combination therapy of temozolomide and radiation has been established as the standard therapy for the initial treatment of glioblastoma. However, the prognosis for patients with recurrent/ refractory glioblastoma is dismal, with a median survival of 3~6 months. There is no efficient and standard care at the time of recurrence or progression following temozolomide administration. Recently, many clinicians have reassessed the efficacy of second-line chemotherapeutic agents such as nitrosoureas for the treatment of recurrent/refractory glioblastoma. It is very important that the effect of the agent is sustained and the adverse effect is reduced to preserve the quality of life in recurrent settings. We have realized that the clinical features of Korean patients are very different from those of foreign patients. Therefore, it is mandatory to develop the new strategy for the treatment of Korean patients. We modify the PCV chemotherapy in the dose and administration schedule of CCNU and procarbazine to reduce the side effect, especially hematologic problems. The dose of CCNU is reduced to 75mg/m2 and the interval between CCNU and procarbazine is increased. Moreover, vincristine is excluded because BBB permeability of vincristine is very poor and the risk of neurotoxicity is high. We introduce the modified PC chemotherapy regimen for the treatment of recurrent/refractory glioblastoma, which is the first multicenter trial for glioblastoma patients in Korea.
- Conditions
- Recurrent Glioblastoma Multiforme
- Being tested
- lomustine and procarbazine
- Keywords
- glioblastoma, recurrent, refractory, CCNU, procarbazine
- Medical subject headings
- Glioblastoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lomustine and procarbazineDrug
Also called CCNU, Matulan
1 cycle (4 weeks) includes CCNU 75mg/m2 (D1) and procarbazine 60mg/m2 (D11-D24)by mouth for up to 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| lomustine and procarbazine | Experimental | 1 cycle (4 weeks) includes CCNU 75mg/m2 (D1) and procarbazine 60mg/m2 (D11-D24)by mouth for up to 6 cycles Receives: Drug: lomustine and procarbazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month progression free survival
Measured: March 31, 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionSep 2013 (estimated)
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Glioblastoma MultiformeStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Incheon St.Mary's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Center, Korea
- Responsible party
- Principal investigator, Dong-Sup Chung, Incheon St.Mary's Hospital
- Investigators
- Don-Sup Chung, MD, Principal investigator, Incheon St. Mary Hispital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01737346
- Sponsor's protocol ID
- KNOG-1201
- Status last verified
- Nov 2012
- First submitted
- 27 Nov 2012
- Last updated
- 3 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Clinical Trial of PC(Procarbazine-CCNU) Chemotherapy in Patients With Recurrent or Resistant Glioblastoma With Methylated MGMT
- ClinicalTrials.gov ID
- NCT01737346
- Acronym / sponsor ID
- KNOG-1201
- Conditions
- Recurrent Glioblastoma Multiforme
- Keywords
- glioblastoma, recurrent, refractory, CCNU, procarbazine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Incheon St.Mary's HospitalUniversity, hospital or other
- Collaborators
- National Cancer Center, Korea
- Study start
- Oct 2012
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 29 Nov 2012 (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 combination therapy of temozolomide and radiation has been established as the standard therapy for the initial treatment of glioblastoma. However, the prognosis for patients with recurrent/ refractory glioblastoma is dismal, with a median survival of 3~6 months. There is no efficient and standard care at the time of recurrence or progression following temozolomide administration. Recently, many clinicians have reassessed the efficacy of second-line chemotherapeutic agents such as nitrosoureas for the treatment of recurrent/refractory glioblastoma. It is very important that the effect of the agent is sustained and the adverse effect is reduced to preserve the quality of life in recurrent settings. We have realized that the clinical features of Korean patients are very different from those of foreign patients. Therefore, it is mandatory to develop the new strategy for the treatment of Korean patients. We modify the PCV chemotherapy in the dose and administration schedule of CCNU and procarbazine to reduce the side effect, especially hematologic problems. The dose of CCNU is reduced to 75mg/m2 and the interval between CCNU and procarbazine is increased. Moreover, vincristine is excluded because BBB permeability of vincristine is very poor and the risk of neurotoxicity is high. We introduce the modified PC chemotherapy regimen for the treatment of recurrent/refractory glioblastoma, which is the first multicenter trial for glioblastoma patients in Korea.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lomustine and procarbazine | Experimental | Drug: lomustine and procarbazine1 cycle (4 weeks) includes CCNU 75mg/m2 (D1) and procarbazine 60mg/m2 (D11-D24)by mouth for up to 6 cycles |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically or radiologically confirmed progressive or recurrent glioblastoma with methylated MGMT promoter
- Within 6 months after or during Stupp regimen (TMZ-RT CCRT + adjuvant TMZ), or After re-treatment of cyclic TMZ, 6 months later after Stupp regimen
- KPS ≥ 60%
- Age ≥ 20 years
- At least two weeks apart from prior surgery and prior chemotherapy
Key exclusion criteria (6 listed)
- Prior malignancy within 5 years except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and carcinoma in situ of the cervix
- maternity or breastfeeding
- Evidence of active infection within 2 weeks prior to study
- Previous treatment with procarbazine and/or CCNU
- Evidence of leptomeningeal metastasis
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 |
|---|---|---|
| lomustine and procarbazineAlso: CCNU, Matulan1 cycle (4 weeks) includes CCNU 75mg/m2 (D1) and procarbazine 60mg/m2 (D11-D24)by mouth for up to 6 cycles | Drug | lomustine and procarbazine |
Primary outcome
6-month progression free survival
Time frame: March 31, 2014
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2012.
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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.
Don-Sup Chung, MD principal investigator
Incheon St. Mary Hispital
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 lomustine and procarbazine in people with Recurrent Glioblastoma Multiforme, run by Incheon St.Mary's Hospital at 1 site in South Korea.
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 8 inclusion and 6 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 3 Dec 2012. 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 South Korea. 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 Dong-Sup Chung, MD (82-32-280-5876, dschung@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-month progression free survival (time frame: March 31, 2014). 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 3 Dec 2012.