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Alkylating Agent

Vorinostat + Temozolomide for Brain Cancer

Phase 1

Waitlist Available

Led By Patrick Y Wen

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with histologically proven intracranial malignant glioma including GBM, GS, AA, AO, AMO, or malignant astrocytoma NOS

Patients with low-grade glioma histology subsequently diagnosed with malignant glioma

Must not have

History of lymphoproliferative disorder or active malignancy

Progression on temozolomide

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the side effects and best dose of vorinostat when given with temozolomide to treat patients with malignant gliomas.

Who is the study for?

This trial is for patients with certain types of brain tumors, including glioblastoma and anaplastic astrocytoma. Participants must have a life expectancy over 8 weeks, be able to perform daily activities at least partially independently (Karnofsky score >=60), and have adequate blood cell counts and organ function. Pregnant or breastfeeding women, HIV-positive patients on antiretrovirals, those with recent other cancers or serious illnesses affecting the study's safety are excluded.

What is being tested?

The trial is testing the combination of two chemotherapy drugs: Vorinostat and Temozolomide. It aims to find the safest dose that can effectively treat malignant gliomas by killing tumor cells or stopping their growth. The study will also look into how these drugs affect enzymes related to cell growth.

What are the potential side effects?

Potential side effects include typical chemotherapy-related issues such as fatigue, nausea, vomiting, decreased appetite, blood count changes leading to increased infection risk or bleeding problems, liver function abnormalities which might cause jaundice or itching, kidney dysfunction potentially causing swelling in legs or abnormal urine output.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a specific type of brain tumor.

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My low-grade brain tumor was later found to be cancerous.

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I can care for myself but may need occasional help.

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My hemoglobin level is at least 10 g/dL, transfusions included.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of cancer or blood cell disorders.

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My condition worsened despite taking temozolomide.

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I do not have any active infections or serious illnesses.

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I have a condition that affects how drugs are broken down in my body.

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I have recently used valproic acid.

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I am HIV positive and on antiretroviral therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Temozolomide

Secondary study objectives

Efficacy in terms of anti-tumor activity based on clinical, radiographic, and biologic assessments (Part II)

Plasma pharmacokinetic parameters of vorinostat

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (vorinostat, temozolomide)Experimental Treatment4 Interventions

PART I: Patients receive vorinostat PO QD or BID on days 1-7 and 15-21 OR QD or BID on days 1-7. Patients also receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity. Treatment may continue beyond 13 courses at the discretion of the investigator. PART II: Patients receive vorinostat and temozolomide as in part I\*. \[Note: Beginning in course 2, some patients may receive a higher dose of temozolomide.\]

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vorinostat

2014

Completed Phase 3

~1600

Temozolomide

2010

Completed Phase 3

~1880