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Phase II Trial of Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Recurrent Glioblastoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Recurrent Adult Brain Tumor

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Trial Information

Phase II Trial of Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Recurrent Glioblastoma


PRIMARY OBJECTIVES:

I. Determine the efficacy of vorinostat (SAHA), in terms of 6-month progression-free
survival, in patients with progressive or recurrent glioblastoma multiforme.

II. Determine the safety and toxicity of this drug in these patients.

SECONDARY OBJECTIVES:

I. Determine the pharmacokinetics of this drug in these patients. II. Determine the biologic
effect of this drug in target tissues, including primary tumor tissue, in these patients.

III. Correlate genetic alteration of tumors with response in patients treated with this
drug.

OUTLINE: This is an open-label, multicenter study. Patients are stratified according to
planned surgery (yes [stratum 1] vs no [stratum 2]) and number of prior chemotherapy
regimens for progressive/recurrent disease (≤ 1 [stratum 1A] vs ≥ 2 [stratum 1B]).

STRATUM 1: Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat
every 3 weeks in the absence of disease progression or unacceptable toxicity. (not
undergoing surgery)

STRATUM 2: Beginning 3 days prior to surgery, patients receive oral SAHA once or twice daily
for a total of 6 doses. Patients then undergo surgery to remove the tumor. Beginning within
1-4 weeks after surgery, patients receive oral SAHA twice daily for 2 weeks. (undergoing
surgery)

Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 5 years.


Inclusion Criteria:



- Histologically confirmed grade 4 astrocytoma (glioblastoma multiforme), including
gliosarcoma, at primary diagnosis or recurrence

- Progressive or recurrent disease

- Measurable or evaluable disease by MRI or CT scan

- Performance status - ECOG 0-2

- WBC ≥ 3,000/mm^3

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 8 g/dL

- AST ≤ 3 times upper limit of normal (ULN)

- Bilirubin normal

- Creatinine ≤ 1.5 times ULN

- No myocardial infarction within the past 6 months

- No congestive heart failure

- No life-threatening ventricular arrhythmia requiring ongoing maintenance therapy

- No known HIV positivity

- Not immunocompromised except if related to the use of corticosteroids

- No known hypersensitivity to any of the components of the study drug

- No uncontrolled infection

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 6 months after
completion of study treatment

- No other malignancy

- No other severe disease that would preclude study participation

- Prior adjuvant chemotherapy allowed

- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)

- More than 2 weeks since prior small molecule cell cycle inhibitor

- Concurrent corticosteroids allowed as long as dose has been stable for ≥ 1 week

- At least 8 weeks since prior radiotherapy

- Must have evidence of tumor progression by MRI or CT scan after radiotherapy

- More than 6 weeks since prior stereotactic radiosurgery or interstitial
brachytherapy, unless 1 of the following criteria is met:

- There is a separate lesion by MRI outside of the prior treatment field

- There is evidence of recurrent disease by biopsy, MRI spectroscopy, or
positron-emission tomography scan

- More than 2 weeks since prior valproic acid

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Description:

Estimated and compared using Kaplan-Meier survival curves and logrank test.

Outcome Time Frame:

From date of registration to date of progression or death due to any cause or last follow-up, assessed up to 5 years

Safety Issue:

No

Principal Investigator

Evanthia Galanis

Investigator Role:

Principal Investigator

Investigator Affiliation:

North Central Cancer Treatment Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-00646

NCT ID:

NCT00238303

Start Date:

September 2005

Completion Date:

Related Keywords:

  • Adult Giant Cell Glioblastoma
  • Adult Glioblastoma
  • Adult Gliosarcoma
  • Recurrent Adult Brain Tumor
  • Brain Neoplasms
  • Glioblastoma
  • Gliosarcoma

Name

Location

North Central Cancer Treatment GroupRochester, Minnesota  55905