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Procarbazine and Lomustine in Recurrent Glioblastoma

NCT ID: NCT01737346

Last Updated: 2012-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Recurrent Glioblastoma Multiforme

Keywords

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glioblastoma, recurrent, refractory, CCNU, procarbazine

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

lomustine and procarbazine

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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CCNU Matulan

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Center, Korea

OTHER_GOV

Sponsor Role collaborator

Incheon St.Mary's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dong-Sup Chung

Professor, Department of Neurosurgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Don-Sup Chung, MD

Role: PRINCIPAL_INVESTIGATOR

Incheon St. Mary Hispital

Locations

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Ajou University Hospital

Wonchondong, Suwon, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Dong-Sup Chung, MD

Role: CONTACT

Phone: 82-32-280-5876

Email: [email protected]

Facility Contacts

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Se-Hyuk Kim, Doctor

Role: primary

Other Identifiers

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KNOG-1201

Identifier Type: -

Identifier Source: org_study_id