CLINICAL TRIAL

Treatment for Sarcoma

1 Prior Treatment
Metastatic
Recurrent
Stage I
Waitlist Available · 18+ · All Sexes · New York, NY

This study is evaluating whether temozolomide is effective in treating patients with advanced soft tissue sarcoma.

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About the trial for Sarcoma

Eligible Conditions
Endometrial Cancer · Sarcoma · Endometrial Neoplasms · Ovarian Cancer

Treatment Groups

This trial involves a single treatment. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Sarcoma or one of the other 3 conditions listed above. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Greater than 12 weeks Hematopoietic: Platelet count at least 100,000/mm3 Hemoglobin greater than 10.0 g/dL WBC at least 3,500/mm3 OR Absolute neutrophil count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT/SGPT no greater than 1.5 times ULN Alkaline phosphatase less than 2 times ULN Renal: Calcium less than ULN Creatinine or BUN less than 1.5 times ULN OR Creatinine clearance greater than 60 mL/min Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or fully excised and/or treated stage I cancer currently in complete remission No nonmalignant systemic disease rendering patient a poor medical risk No acute infection requiring IV antibiotics HIV negative No AIDS-related illness No frequent vomiting or medical condition that could interfere with oral medication intake (e.g., partial bowel obstruction)
An individual with histologically, cytologically, or clinically confirmed unresectable, stage IV, or recurrent soft tissue sarcoma, who does not have Ewing's sarcoma, Kaposi's sarcoma, bone sarcomas, mesotheliomas, or primitive neuroectodermal tumors, and who has bidimensionally measurable disease by x-ray, CT scan or MRI, or physical examination, but no CNS metastases, is not eligible for further treatment with chemotherapy. show original
PRIOR CONCURRENT THERAPY: Biologic therapy: Prior biologic response modifier treatment allowed At least 4 weeks since prior immunotherapy At least 4 weeks since prior biologic therapy No concurrent epoetin alfa Chemotherapy: See Disease Characteristics Prior dacarbazine allowed At least 4 weeks since prior chemotherapy No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy for malignancy Radiotherapy: At least 3 weeks since prior radiotherapy and recovered No prior radiotherapy to areas of measurable disease unless there is clear progression or there is measurable disease outside the area of prior radiation No concurrent radiotherapy Surgery: At least 4 weeks since prior surgery and recovered Other: No other concurrent investigational drug
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 5 years
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 5 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 5 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Patient Q & A Section

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

What is sarcoma?

Sarcoma is a cancer that starts in connective or other soft tissue. The sarcomas that are the most common are leiomyosarcomas, rhabdomyosarcomas, and Ewing's sarcomas. Other forms occur, but less often than the others. This article describes the signs and symptoms, pathologic features, and treatment of sarcoma.

Anonymous Patient Answer

How many people get sarcoma a year in the United States?

There is a significant incidence of ESCC, ECC, and ESS in the United States (1, 8, 9). Based on epidemiologic data from the US SEER database, it is expected that 2,739 people develop ESCC, 2,4,062 people develop ECC, and 3,151 people develop ESS per year in the United States (9). A recent meta-analysis of 12 studies in the literature examining the incidence of cancers by race/ethnicity also found that ESCC was the most common neoplasm in Asian Americans, African Americans, and Hispanics. It is not known what portion of the 2,789 individuals with ESCC reported that they were not vaccinated against rabies (9).

Anonymous Patient Answer

Can sarcoma be cured?

Sarcoma cannot be cured, since all people will experience some adverse effects as a result of chemotherapy and will relapse. For this reason, the aim of chemotherapy is to reduce the risk of relapse, but not to cure the sarcoma.

Anonymous Patient Answer

What causes sarcoma?

It appears that a mutation to the p53 gene can cause sarcoma in patients who often have radiation exposure. This effect is especially strong in children who had no previous radiation exposure and in older patients who had no exposure of any kind. Oncogene mutations can also be important, as a cancer susceptibility gene and an oncogene have been identified in this disorder.

Anonymous Patient Answer

What are the signs of sarcoma?

This article describes the signs that may appear on computed tomography. These signs may help the radiologist to form strong diagnostic impressions without the aid of conventional imaging such as X-rays or radiographs.

Anonymous Patient Answer

What are common treatments for sarcoma?

Treatment for sarcoma depends on the type of cancer and how far it has spread. Common treatments include surgery, radiation therapy, chemotherapy, targeted therapy, immunotherapy, or a combination of the foregoing. Sarcomas are the most prevalent of the soft tissue tumors evaluated. Lymphatic and cutaneous sarcomas are common.\n

Anonymous Patient Answer

Has treatment proven to be more effective than a placebo?

The review found no convincing evidence that treatment is more effective than is a placebo in reducing patient-reported metastasis risk, quality of life or overall tumor size.

Anonymous Patient Answer

Who should consider clinical trials for sarcoma?

Clinicians should consider enrollment into clinical trials of investigational agents for sarcomas; however, only a small proportion of clinical trial populations enroll patients with sarcomas. Most patients with sarcomas are treated aggressively, and the overall survival rates for such patients are comparable (and potentially greater) when compared with patients treated outside clinical trials. Prospective trials evaluating outcomes of patients with sarcomas treated in an academic setting vs patients treated in a clinical trial setting should be conducted.

Anonymous Patient Answer

What is the average age someone gets sarcoma?

Age-related trends were very different than we expected. Most sarcomas occur in a wide range of patients, from infants to individuals in their 80s. The median age of diagnosis is 59 years but this may reflect advances during routine testing rather than detection of sarcomas by screening. Further research is needed to understand the changes in patterns of disease presentation with advances in diagnostic modalities and improved awareness of risk factors in different age groups.

Anonymous Patient Answer

What does treatment usually treat?

Most of the current treatments for primary cutaneous T-cell lymphomas are ineffective, although an assortment of other immune-modulating agents, such as interferon-α, may be used in selected patients. Data from a recent study, the most frequent response in patients with newly diagnosed cutaneous T-cell lymphoma was that of complete remission, with a response rate of 80%. The treatment usually follows an (extremely) intense combination chemotherapy with a corticosteroid (e.g. prednisone) for most patients. The objective of treatment will be to kill the tumor while ensuring the individual's functional immune system remains intact. Treatment of all skin cancers (i.e.

Anonymous Patient Answer

Have there been other clinical trials involving treatment?

The high number of trial proposals and reported results suggests that the clinical trials are not just sporadic but rather part of the overall evidence base for clinical interventions. The number of ongoing clinical trials in all categories is high; however, the findings of many clinical trials are inconclusive and may not be of clinical significance to the people concerned with care of cancer patients. Clinical trials should include a patient-oriented endpoint and measure quality of life using validated health questionnaire.

Anonymous Patient Answer
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