Procarbazine and Lomustine in Recurrent Glioblastoma

Incheon St.Mary's Hospital

Status and phase

Unknown

Phase 2

Conditions

Recurrent Glioblastoma Multiforme

Treatments

Drug: lomustine and procarbazine

Study type

Interventional

Funder types

Other

Identifiers

NCT01737346

KNOG-1201

Details and patient eligibility

About

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.

Enrollment

52 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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