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Phase 2 Clinical Trial of PC(Procarbazine-CCNU) Chemotherapy in Patients With Recurrent or Resistant Glioblastoma With Methylated MGMT


Phase 2
20 Years
N/A
Open (Enrolling)
Both
Recurrent Glioblastoma Multiforme

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Trial Information

Phase 2 Clinical Trial of PC(Procarbazine-CCNU) Chemotherapy in Patients With Recurrent or Resistant Glioblastoma With Methylated MGMT


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

6-month progression free survival

Outcome Time Frame:

March 31, 2014

Safety Issue:

Yes

Principal Investigator

Don-Sup Chung, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Incheon St. Mary Hispital

Authority:

South Korea: Korea Food and Drug Administration (KFDA)

Study ID:

KNOG-1201

NCT ID:

NCT01737346

Start Date:

October 2012

Completion Date:

April 2014

Related Keywords:

  • Recurrent Glioblastoma Multiforme
  • glioblastoma, recurrent, refractory, CCNU, procarbazine
  • Glioblastoma

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