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Alkylating agent

Temozolomide + Thalidomide for Leiomyosarcoma

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

Histologically confirmed leiomyosarcoma

Metastatic, locally advanced, or unresectable

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is studying how well combining temozolomide with thalidomide works in treating patients with leiomyosarcoma.

Who is the study for?

This trial is for adults with leiomyosarcoma that's spread, can't be removed by surgery, or is locally advanced. They should have a life expectancy over 2 months and be able to perform daily activities (SWOG 0-2). Key health requirements include normal liver function tests, no severe vomiting conditions, no recent cancers except certain skin or cervical cancers, and no brain metastases. Participants must not be pregnant and agree to use two forms of contraception.Check my eligibility

What is being tested?

The study is testing the combination of two drugs: Temozolomide and Thalidomide. The goal is to see if this combo is more effective in stopping cancer growth by disrupting tumor blood supply and cell division in patients with leiomyosarcoma that cannot be treated with surgery.See study design

What are the potential side effects?

Temozolomide may cause nausea, fatigue, hair loss, constipation or diarrhea. Thalidomide can lead to drowsiness, rash or nerve damage causing numbness or tingling sensations. Both drugs could potentially lower your body's ability to fight infections.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is confirmed as leiomyosarcoma through tissue analysis.

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My cancer has spread, cannot be surgically removed, or is in an advanced stage.

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I have a tumor that can be measured, is at least 2 cm, not treated with radiation unless it's growing, and no brain cancer.

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My liver function tests are within normal ranges.

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My kidney function tests are within normal limits.

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I am 18 years old or older.

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I can take care of myself and perform daily activities.

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

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Response (complete and partial response)

Secondary outcome measures

Clinical benefit

Overall survival

Time to progression

0 / 7Eligibility 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

4 Trials studying Sarcoma

52 Patients Enrolled for Sarcoma

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,153 Total Patients Enrolled

453 Trials studying Sarcoma

230,099 Patients Enrolled for Sarcoma

Robert N. Taub, MD, PhDStudy ChairHerbert Irving Comprehensive Cancer Center

6 Previous Clinical Trials

109 Total Patients Enrolled

4 Trials studying Sarcoma

52 Patients Enrolled for Sarcoma

Media Library

Temozolomide (Alkylating agent) Clinical Trial Eligibility Overview. Trial Name: NCT00033709 — Phase 2

Sarcoma Clinical Trial 2023: Temozolomide Highlights & Side Effects. Trial Name: NCT00033709 — Phase 2

Temozolomide (Alkylating agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00033709 — Phase 2

Frequently Asked Questions

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

What are the odds of experiencing negative side effects from this medication?

"While there is some evidence suggesting this treatment may be safe, efficacy has not been proven. Therefore, it received a score of 2."

Answered by AI

Are patients being actively sought for this experiment?

"According to data on clinicaltrials.gov, this trial is not currently looking for patients as it last did on 1/3/2014. 477 other trials are actively recruiting right now."

Answered by AI