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Vorinostat in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme

Study Purpose

This phase II trial is studying how well vorinostat works in treating patients with progressive or recurrent glioblastoma multiforme. Drugs used in chemotherapy, such as vorinostat, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vorinostat before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving it after surgery may kill any remaining tumor cells.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00238303
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 National Cancer Institute (NCI)
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Evanthia Galanis
Principal Investigator Affiliation North Central Cancer Treatment Group
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 NIH
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Recurrent Adult Brain Tumor
Additional Details

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.#46;no [stratum 2]) and number of prior chemotherapy regimens for progressive/recurrent disease (≤ 1 [stratum 1A] vs.#46;≥ 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.

Arms & Interventions

Arms

Experimental: Stratum 1 (not undergoing surgery)

Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Experimental: Stratum 2 (undergoing surgery)

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

Interventions

Drug: - vorinostat

Given orally

Procedure: - conventional surgery

Patients undergo surgery to remove tumor

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

North Central Cancer Treatment Group, Rochester, Minnesota

Status

Address

North Central Cancer Treatment Group

Rochester, Minnesota, 55905

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