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Procarbazine and Lomustine in Recurrent Glioblastoma

Sponsor
Incheon St.Mary's Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01737346
Collaborator
National Cancer Center, Korea (Other)
52
Enrollment
1
Location
1
Arm
18
Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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 or Disease Intervention/Treatment Phase
  • Drug: lomustine and procarbazine
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
52 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (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
Study Start Date :
Oct 1, 2012
Anticipated Primary Completion Date :
Sep 1, 2013
Anticipated Study Completion Date :
Apr 1, 2014

Arms and Interventions

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

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:
  • CCNU
  • Matulan

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 6-month progression free survival [March 31, 2014]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    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

    Locations

    Site City State Country Postal Code
    1 Ajou University Hospital Wonchon-dong Suwon Korea, Republic of 443-721

    Sponsors and Collaborators

    • Incheon St.Mary's Hospital
    • National Cancer Center, Korea

    Investigators

    • Principal Investigator: Don-Sup Chung, MD, Incheon St. Mary Hispital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dong-Sup Chung, Professor, Department of Neurosurgery, Incheon St.Mary's Hospital
    ClinicalTrials.gov Identifier:
    NCT01737346
    Other Study ID Numbers:
    • KNOG-1201
    First Posted:
    Nov 29, 2012
    Last Update Posted:
    Dec 3, 2012
    Last Verified:
    Nov 1, 2012
    Keywords provided by Dong-Sup Chung, Professor, Department of Neurosurgery, Incheon St.Mary's Hospital
    glioblastoma, recurrent, refractory, CCNU, procarbazine
    Additional relevant MeSH terms:
    Glioblastoma
    Recurrence
    Lomustine
    Procarbazine

    Study Results

    No Results Posted as of Dec 3, 2012