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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Temozolomide
Secondary outcome measures
Efficacy in terms of anti-tumor activity based on clinical, radiographic, and biologic assessments (Part II)
Plasma pharmacokinetic parameters of vorinostat

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
~1930

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,609 Previous Clinical Trials
40,915,563 Total Patients Enrolled
142 Trials studying Gliosarcoma
10,750 Patients Enrolled for Gliosarcoma
Patrick Y WenPrincipal InvestigatorNational Cancer Institute (NCI)

Media Library

Temozolomide (Alkylating Agent) Clinical Trial Eligibility Overview. Trial Name: NCT00268385 — Phase 1
Gliosarcoma Research Study Groups: Treatment (vorinostat, temozolomide)
Gliosarcoma Clinical Trial 2023: Temozolomide Highlights & Side Effects. Trial Name: NCT00268385 — Phase 1
Temozolomide (Alkylating Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00268385 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What applications is Vorinostat generally employed for?

"With Vorinostat, nitrosourea treatment and progressive cutaneous t-cell lymphoma can be managed. Additionally, advance directives are within its scope of application."

Answered by AI

Has the Vorinostat drug been authorized by the US Food and Drug Administration?

"As a Phase 1 trial, Vorinostat's safety has been tested to some degree but not extensively. Thus, it received a score of 1 as determined by our team at Power."

Answered by AI

Could you please elucidate the scope of research surrounding Vorinostat?

"Currently, 235 studies are underway examining Vorinostat's effects. Of these active investigations, 24 have advanced to Phase 3 clinical trials. While the majority of research is occurring in Seoul Songpa, there exists an international network of 5392 sites running various tests on this medication."

Answered by AI

What is the scope of this research project in terms of participants?

"Unfortunately, this trial is not currently accepting new participants. It was established on December 16th 2005 and last amended November 16th 2022. If you're seeking other studies related to brain cancer, there are 1047 trials open for recruitment; alternatively 235 clinical trials concerning Vorinostat also have spots available."

Answered by AI

How many physical sites are participating in this experiment?

"Participants can enroll in this clinical trial at Wake Forest University Health Sciences (Winston-Salem, NC), Cleveland Clinic Foundation (Cleveland, OH) and Moffitt Cancer Center (Tampa, FL). Additionally, there are 18 other sites across the nation."

Answered by AI

Are there remaining vacancies in this research program for participants?

"This particular trial is not presently seeking participants. The protocol was first published on December 16th 2005 with the most recent edits occurring on November 16th 2022. If you are interested in alternative trials, 1047 brain cancer studies and 235 Vorinostat tests are actively accepting patients."

Answered by AI

Is this research pioneering a new field of inquiry?

"Since 2002, researchers have conducted over 235 clinical trials of Vorinostat in 971 cities and 37 countries; with the initial study sponsored by Schering-Plough. After this first test involving 60 patients, Phase 2 drug approval was granted for Vorinostat."

Answered by AI
~4 spots leftby Mar 2025