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Alkylating agent

Temozolomide for Brain Cancer

Phase 2

Waitlist Available

Research Sponsored by Herbert Irving Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

Karnofsky performance status 70-100%

No other serious concurrent infection or medical illness that would preclude study entry, No frequent vomiting or partial bowel obstruction, HIV negative, No AIDS-related illness, No other concurrent malignancy except carcinoma in situ of the cervix or basal cell skin cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is studying how well temozolomide works in treating patients with recurrent or progressive malignant glioma.

Who is the study for?

This trial is for adults over 18 with recurrent or progressive malignant glioma who have measurable disease by CT scan or MRI. They must be in good physical condition (Karnofsky score of 70-100%), not pregnant, using barrier contraception if fertile, and without serious infections or other medical issues that could interfere with the study. Prior radiotherapy is okay, but no recent chemotherapy (6 weeks) or concurrent investigational agents.Check my eligibility

What is being tested?

The effectiveness of temozolomide, a chemotherapy drug, is being tested on patients with specific types of brain tumors that are worsening despite previous treatments. This phase II trial aims to see how well it stops tumor cells from growing and causing them to die.See study design

What are the potential side effects?

Temozolomide can cause side effects such as fatigue, headaches, nausea and vomiting, constipation or diarrhea, loss of appetite and weight changes. It may also lower blood cell counts increasing infection risk and cause hair thinning or loss.

Eligibility Criteria

Inclusion Criteria

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

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I am mostly able to care for myself and carry out daily activities.

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I don't have serious infections, frequent vomiting, bowel issues, HIV/AIDS, or other cancers except possibly skin cancer or cervical carcinoma in situ.

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I am 18 years old or older.

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My brain tumor is confirmed to be growing or returning.

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My cancer did not respond to radiation treatment.

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My kidney function tests are within normal limits.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Herbert Irving Comprehensive Cancer CenterLead Sponsor

33 Previous Clinical Trials

929 Total Patients Enrolled

Casilda Balmaceda, MDStudy ChairHerbert Irving Comprehensive Cancer Center

Media Library

Temozolomide (Alkylating agent) Clinical Trial Eligibility Overview. Trial Name: NCT00004204 — Phase 2

Brain Tumor Clinical Trial 2023: Temozolomide Highlights & Side Effects. Trial Name: NCT00004204 — Phase 2

Temozolomide (Alkylating agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00004204 — Phase 2

Frequently Asked Questions

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

Is this clinical test currently accepting participants?

"As per clinicaltrials.gov, this medical trial is not actively recruiting participants at the moment, having first been posted on February 1st 2000 and last updated on January 3rd 2014. However there are 435 other trials that patients may be eligible for currently."

Answered by AI

Has the FDA sanctioned this particular procedure?

"Our team evaluated this medication's safety to be a 2 because it is still only in Phase 2, indicating that there are some studies proving safety but no data validating efficacy."

Answered by AI

How many health facilities are facilitating this clinical trial?

"This research project is being conducted across 10 sites, with major facilities such as the Stanford University Medical Center in California, Mount Sinai Comprehensive Cancer Centre in Miami Beach and University of Pennsylvania Cancer Centre located in Philadelphia."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Temozolomide in Treating Patients With Recurrent or Progressive Malignant Glioma

2000. "Temozolomide in Treating Patients With Recurrent or Progressive Malignant Glioma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00004204.

All > Glioma