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Nivolumab + Chemotherapy for Soft Tissue Sarcoma
Study Summary
This trial is testing the effectiveness of two drugs, paclitaxel and cabozantinib, in treating patients with soft tissue sarcoma. The first group of patients will receive paclitaxel, and the second group will receive paclitaxel and cabozantinib. The trial is being done to see if the combination of the two drugs can shrink the tumor and prevent it from coming back.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2014 Phase 4 trial • 32 Patients • NCT01301729Trial Design
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Who is running the clinical trial?
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- I am not currently taking aspirin (more than 81 mg/day) or any blood thinners.I am fully active or can carry out light work.Your platelet count is at least 100,000 per cubic millimeter.Your bilirubin levels must be within a certain range, unless you have Gilbert's disease, in which case a higher level is allowed.I do not have any serious wounds that are not healing.Your hemoglobin level is at least 9.0 grams per deciliter.I haven't had any cancer except for skin cancer in the last 5 years.I can provide slides of my tumor for review.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I have never been treated with PD-1 or PD-L1 inhibitors.My cancer is an angiosarcoma caused by radiation.I am not pregnant or nursing and, if capable of becoming pregnant, I have a recent negative pregnancy test.I finished all cancer treatments at least 7 days ago, except for prostate cancer treatment which can continue.I have never received VEGF TKI therapy.Your kidneys are working well enough, with a certain level of creatinine clearance.I do not have uncontrolled brain tumors.My liver function tests are within the required range and I don't have severe liver disease.I am not on high-dose steroids or other immune-weakening drugs.You can join the study if you have certain conditions like vitiligo, type I diabetes, or psoriasis that doesn't need strong medication.I have recovered from previous cancer treatment side effects, except for possible mild fatigue or hair loss.I haven't had a blood clot in the past month.My kidney function test for protein is within normal limits.I don't have any serious illnesses that would make this study unsafe for me.I am not allergic to paclitaxel, cabozantinib, nivolumab, or their ingredients.I haven't had major surgery, except for a biopsy, in the last 28 days.My angiosarcoma can't be cured with surgery or I've chosen not to undergo curative treatment.I am HIV-positive, on treatment, and my viral load is undetectable.I do not have untreated spinal issues related to my cancer.I have never been treated with taxane for my angiosarcoma.I am not on certain blood thinners but can use low-dose heparin unless I have brain metastases or bleeding issues.I haven't had serious heart issues or strokes in the last 3 months.I can speak and understand English or Spanish well enough to complete required forms.I am not taking strong CYP3A4 inhibitors or inducers, or can stop them as required before joining the study.I do not have any planned pain relief procedures like radiation or surgery.My cancer can be measured and has grown after my last cancer treatment.I have a history of cancer.I am 18 years old or older.I have had a condition where my lymphocytes multiply unusually.You have enough infection-fighting white blood cells in your body.I have not experienced significant nerve pain or damage.
- Group 1: Arm I (nivolumab, paclitaxel)
- Group 2: Arm II (paclitaxel)
- Group 3: Arm III (nivolumab, cabozantinib S-malate)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Are people still being enrolled in this experiment?
"This clinical trial is currently recruiting patients, according to the information available on clinicaltrials.gov. The original posting date for the trial was 9/4/2020, and it was last updated on 11/16/2022."
Are there different research centers participating in this trial throughout the US?
"Queen's Cancer Center - Kuakini in Honolulu, Hawaii, Smilow Cancer Hospital-Orange Care Center in Orange, Connecticut and Siteman Cancer Center at Christian Hospital in Saint Louis, Missouri are a few of the 100+ locations where patients can enroll in this study."
How many people have signed up to participate in this experiment?
"That is correct, the online information does show that this study requires participants. The listing was created on September 4th 2020 with the most recent update being November 16th 2022. They are 90 patients needed in total from 100 hospitals or research centres."
Can you explain what Paclitaxel is most often used to treat?
"Various forms of aggressive cancer, such as unresectable melanoma and squamous cell carcinoma, can be mitigated through Paclitaxel treatment."
What is the precedence of Paclitaxel in medical research?
"City of Hope Comprehensive Cancer Center first researched paclitaxel in 1997 and, since then, 1644 completed trials have yielded data. As of now, there are 1657 ongoing clinical trials; a considerable number of these studies take place in Honolulu, Hawaii."
Has Paclitaxel been cleared by the FDA?
"Paclitaxel is still being clinically tested for both efficacy and safety. Right now, there is some evidence to support its safety, but none to suggest that it actually works. Our team gave it a 2."
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