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Alkylating agent
Temozolomide for Sarcoma
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
Performance status: ECOG 0-2
Age: 18 and over
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing the effectiveness of temozolomide in treating patients with advanced soft tissue sarcoma.
Who is the study for?
This trial is for patients with advanced soft tissue sarcoma that can't be surgically removed, is in stage IV, or has come back after treatment. They must have a confirmed diagnosis and measurable disease by scans or physical exam. It's not open to those with certain types of sarcomas like Ewing's or bone sarcomas, nor to patients who've had more than two chemotherapy treatments for advanced cancer.Check my eligibility
What is being tested?
The study is testing the effectiveness of Temozolomide, a chemotherapy drug, on patients with advanced soft tissue sarcoma. This phase II trial aims to see how well it works in stopping cancer cells from growing by interfering with their division.See study design
What are the potential side effects?
Temozolomide may cause side effects such as fatigue, nausea and vomiting, hair loss, constipation or diarrhea, headache and potential blood-related issues like low white blood cell count which could increase infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to get out of my bed or chair and move around.
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I am 18 years old or older.
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My disease can be measured by scans or physical exams.
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I am not currently on IV antibiotics for an infection.
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I do not have any AIDS-related illnesses.
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My liver tests are within the required limits.
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My kidney function tests are within normal limits.
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My sarcoma cannot be removed by surgery and is either stage IV or has come back.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Find a Location
Who is running the clinical trial?
Herbert Irving Comprehensive Cancer CenterLead Sponsor
33 Previous Clinical Trials
904 Total Patients Enrolled
4 Trials studying Sarcoma
27 Patients Enrolled for Sarcoma
Robert N. Taub, MD, PhDStudy ChairHerbert Irving Comprehensive Cancer Center
6 Previous Clinical Trials
84 Total Patients Enrolled
4 Trials studying Sarcoma
27 Patients Enrolled for Sarcoma
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Eligibility Criteria:
This trial includes the following eligibility criteria:- It's been over 3 weeks since my last radiotherapy and I've recovered.I am not receiving any other chemotherapy treatments.I am able to get out of my bed or chair and move around.I am 18 years old or older.I am not currently taking epoetin alfa.It's been over 4 weeks since my last surgery and I've recovered.My disease can be measured by scans or physical exams.I am not currently on IV antibiotics for an infection.I do not have any serious illnesses besides cancer.My cancer has not spread to my brain.I do not have any AIDS-related illnesses.My cancer is not Ewing's, Kaposi's sarcoma, bone sarcoma, mesothelioma, or a primitive neuroectodermal tumor.My liver tests are within the required limits.My kidney function tests are within normal limits.I have had 2 or fewer chemotherapy treatments for my advanced cancer.I am not currently on hormonal therapy for cancer.I haven't had radiation on my measurable cancer areas, or if I did, the cancer has gotten worse or spread.My sarcoma cannot be removed by surgery and is either stage IV or has come back.I haven't had any cancer in the past 5 years, except for certain skin cancers, cervical pre-cancer, or a stage I cancer that is now fully treated and in remission.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still availability to participate in this experiment?
"The study in question is no longer actively seeking participants, as indicated by clinicaltrials.gov. Initially posted on September 1st 1998, the last update was made on March 3rd 2014. Though this research has concluded its candidate search, there are still 1041 trials that require volunteers at present."
Answered by AI
Has this therapeutic modality been sanctioned by the FDA?
"Our team has rated the safety of this intervention a 2, as there is no pre-existing data supporting efficacy but some evidence of safe use in clinical studies."
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