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Procarbazine and Lomustine in Recurrent Glioblastoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01737346
Recruitment Status : Unknown
Verified November 2012 by Dong-Sup Chung, Incheon St.Mary's Hospital.
Recruitment status was:  Recruiting
First Posted : November 29, 2012
Last Update Posted : December 3, 2012
National Cancer Center, Korea
Information provided by (Responsible Party):
Dong-Sup Chung, Incheon St.Mary's Hospital

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
Recurrent Glioblastoma Multiforme Drug: lomustine and procarbazine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 2012
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : April 2014

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

Primary Outcome Measures :
  1. 6-month progression free survival [ Time Frame: March 31, 2014 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01737346

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Contact: Dong-Sup Chung, MD 82-32-280-5876

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Korea, Republic of
Ajou University Hospital Recruiting
Wonchon-dong, Suwon, Korea, Republic of, 443-721
Contact: Se-Hyuk Kim, Doctor    82-31-219-5235   
Principal Investigator: Se-Hyuk Kim, Doctor         
Sponsors and Collaborators
Incheon St.Mary's Hospital
National Cancer Center, Korea
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Principal Investigator: Don-Sup Chung, MD Incheon St. Mary Hispital
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Responsible Party: Dong-Sup Chung, Professor, Department of Neurosurgery, Incheon St.Mary's Hospital Identifier: NCT01737346    
Other Study ID Numbers: KNOG-1201
First Posted: November 29, 2012    Key Record Dates
Last Update Posted: December 3, 2012
Last Verified: November 2012
Keywords provided by Dong-Sup Chung, Incheon St.Mary's Hospital:
glioblastoma, recurrent, refractory, CCNU, procarbazine
Additional relevant MeSH terms:
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Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents