- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01737346
Procarbazine and Lomustine in Recurrent Glioblastoma
November 30, 2012 updated by: Dong-Sup Chung, Incheon St.Mary's Hospital
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
52
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Dong-Sup Chung, MD
- Phone Number: 82-32-280-5876
- Email: dschung@catholic.ac.kr
Study Locations
-
-
Suwon
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Wonchon-dong, Suwon, Korea, Republic of, 443-721
- Recruiting
- Ajou University Hospital
-
Contact:
- Se-Hyuk Kim, Doctor
- Phone Number: 82-31-219-5235
- Email: nsksh@ajou.ac.kr
-
Principal Investigator:
- Se-Hyuk Kim, Doctor
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: lomustine and procarbazine
1 cycle (4 weeks) includes CCNU 75mg/m2 (D1) and procarbazine 60mg/m2 (D11-D24)by mouth for up to 6 cycles
|
1 cycle (4 weeks) includes CCNU 75mg/m2 (D1) and procarbazine 60mg/m2 (D11-D24)by mouth for up to 6 cycles
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
6-month progression free survival
Time Frame: March 31, 2014
|
March 31, 2014
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Don-Sup Chung, MD, Incheon St. Mary Hispital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (Anticipated)
September 1, 2013
Study Completion (Anticipated)
April 1, 2014
Study Registration Dates
First Submitted
November 27, 2012
First Submitted That Met QC Criteria
November 27, 2012
First Posted (Estimate)
November 29, 2012
Study Record Updates
Last Update Posted (Estimate)
December 3, 2012
Last Update Submitted That Met QC Criteria
November 30, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Disease Attributes
- Astrocytoma
- Glioma
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Glioblastoma
- Recurrence
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Lomustine
- Procarbazine
Other Study ID Numbers
- KNOG-1201
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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