Procarbazine and Lomustine in Recurrent Glioblastoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Incheon St.Mary's Hospital
Sponsor:
Collaborator:
National Cancer Center, Korea
Information provided by (Responsible Party):
Dong-Sup Chung, Incheon St.Mary's Hospital
ClinicalTrials.gov Identifier:
NCT01737346
First received: November 27, 2012
Last updated: November 30, 2012
Last verified: November 2012
  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

Resource links provided by NLM:


Further study details as provided by Incheon St.Mary's Hospital:

Primary Outcome Measures:
  • 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:
  • CCNU
  • Matulan

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01737346

Contacts
Contact: Dong-Sup Chung, MD 82-32-280-5876 dschung@catholic.ac.kr

Locations
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         
Sponsors and Collaborators
Incheon St.Mary's Hospital
National Cancer Center, Korea
Investigators
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 August 28, 2014