Procarbazine and Lomustine in Recurrent Glioblastoma
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Recurrent Glioblastoma Multiforme |
Drug: lomustine and procarbazine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase 2 Clinical Trial of PC(Procarbazine-CCNU) Chemotherapy in Patients With Recurrent or Resistant Glioblastoma With Methylated MGMT |
- 6-month progression free survival [ Time Frame: March 31, 2014 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 52 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Drug: 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
Other Names:
|
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Dong-Sup Chung, MD | 82-32-280-5876 | dschung@catholic.ac.kr |
| Korea, Republic of | |
| Ajou University Hospital | Recruiting |
| Wonchon-dong, Suwon, Korea, Republic of, 443-721 | |
| Contact: Se-Hyuk Kim, Doctor 82-31-219-5235 nsksh@ajou.ac.kr | |
| Principal Investigator: Se-Hyuk Kim, Doctor | |
| Principal Investigator: | Don-Sup Chung, MD | Incheon St. Mary Hispital |
More Information
No publications provided
| Responsible Party: | Dong-Sup Chung, Professor, Department of Neurosurgery, Incheon St.Mary's Hospital |
| ClinicalTrials.gov Identifier: | NCT01737346 History of Changes |
| Other Study ID Numbers: | KNOG-1201 |
| Study First Received: | November 27, 2012 |
| Last Updated: | November 30, 2012 |
| Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Keywords provided by Incheon St.Mary's Hospital:
|
glioblastoma, recurrent, refractory, CCNU, procarbazine |
Additional relevant MeSH terms:
|
Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms, Nerve Tissue Lomustine Procarbazine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013