Procarbazine and Lomustine in Recurrent Glioblastoma

NCT01737346 | Unknown Phase 2 DMC

• 1 other identifier: KNOG-1201
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Glioblastoma Multiforme

Keywords

glioblastoma, recurrent, refractory, CCNU, procarbazine

Outcome Measures

Primary Outcomes (1)

• 6-month progression free survival

  March 31, 2014

Study Arms (1)

lomustine and procarbazine

EXPERIMENTAL

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

Interventions

lomustine and procarbazine DRUG

1 cycle (4 weeks) includes CCNU 75mg/m2 (D1) and procarbazine 60mg/m2 (D11-D24)by mouth for up to 6 cycles

Also known as: CCNU, Matulan

lomustine and procarbazine

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Ajou University Hospital

Wonchondong, Suwon, 443-721, South Korea

RECRUITING

MeSH Terms

Conditions

Glioblastoma; Recurrence

Interventions

Lomustine; Procarbazine

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds; Benzamides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Don-Sup Chung, MD

  Incheon St. Mary Hispital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong-Sup Chung, MD

CONTACT

82-32-280-5876; dschung@catholic.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Neurosurgery

Study Record Dates

• First Submitted: November 27, 2012
• First Posted: November 29, 2012
• Study Start: October 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: April 1, 2014
• Last Updated: December 3, 2012

Record last verified: 2012-11

Locations

KR (1)