Sarcoma Clinical Trials

8 trials identified.

Karyopharm - SEAL for De-differentiated Liposarcoma
Principal Investigator: Riedel, Richard
Protocol Number: PRO00072155

Age Group: Adult
Scope: National

Phase: II/III (Cancer Control)
Disease Site: Soft Tissue

Contact: DCI Clinical Research Team, Sarcoma
Email:

What is the Condition Being Studied?
Liposarcoma 
What is the Purpose of this Study?
We are doing this study to find out if study drug (selinexor) is safe and will work with patients who have de-differentiated liposarcoma compared to patients taking the placebo.
Who Can Participate in the Study?
Adults with a diagnosis of de-differentiated liposarcoma that is unresectable (unsuitable for surgery)
What is Involved?
If you choose to join this study, you will be involved in two parts: Screening and Treatment.

During Screening, you will:
- Have a physical exam
- Have blood draws, and a possible tumor tissue biopsy
- Complete quality of life surveys

During Treatment, you will:
- Be randomized (like flipping a coin) to get the study drug, selinexor, or a placebo (sugar pill) 
- Complete tests, exams, and procedures that are standard of care and for study purposes 
- Take the study drug or placebo for 6 week cycles until your disease gets worse or your physician asks you to stop
Participating Institutions:
  • Duke University Health System : Sarcoma DCI Clinical Research Team
View this trial at ClinicalTrials.gov

AROG ARO-012 for GIST with D842V mutation in the PDGFRA gene (Gastrointestinal Stromal Tumors)
Principal Investigator: Riedel, Richard
Protocol Number: PRO00075745

Age Group: Adult
Scope: National

Phase: III (Cancer Control)
Disease Site: Soft Tissue

Contact: DCI Clinical Research Team, Sarcoma
Email:

What is the Condition Being Studied?
Advanced GIST tumors (gastrointestinal stromal tumors) 
What is the Purpose of this Study?
We are doing this study to learn if the study drug crenolanib will work versus placebo (sugar pill) in patients with GIST. 
Who Can Participate in the Study?
Adults with:
- Advanced GIST with a specific genetic abnormalilty (D842V mutation in the PDGFRA gene) 
- Disease progression within 6 months of entering the study. 
- No other therapy within 3 weeks of entering the study
What is Involved?
If you choose to join this study, you will:
- Be randomized (like the flip of a coin) to get crenolanib or placebo (sugar pills) pills that are taken by mouth 3 times a day as long as you are not getting worse.  
- Return to Duke for study visits once a month. 
Participating Institutions:
  • Duke University Health System : Sarcoma DCI Clinical Research Team
View this trial at ClinicalTrials.gov

Tokalas TK216-01 (Ewing Sarcoma)
Principal Investigator: Riedel, Richard
Protocol Number: PRO00076775

Age Group:
Scope:

Phase: I
Disease Site: Bones and Joints

Contact: DCI Clinical Research Team, Sarcoma
Email:

What is the Condition Being Studied?
Ewing Sarcoma
What is the Purpose of this Study?
We are doing this study to find out how safe and if the study drug (TK216) will work in patients with Ewing Sarcoma.
Who Can Participate in the Study?
Adults with a diagnosis of Ewing Sarcoma whose cancer has gotten worse with standard therapy.
What is Involved?
If you choose to join this study, you will:

Be involved in two parts: Screening and Treatment

During Screening, you will have:
- A physical exam
- A urine sample
- Several imaging tests

During Treatment, you will:
- Be admitted to hospital to get study drug
- Get the study drug (TK216), infused through a central line (an I.V.) until your cancer gets worse, or the study doctor takes you off of the study
Participating Institutions:
  • Duke Cancer Center Cary : Sarcoma DCI Clinical Research Team
  • Duke Center for Living/Sarah Stedman Nutrition : Sarcoma DCI Clinical Research Team
  • Duke Primary Care : Sarcoma DCI Clinical Research Team
  • Duke Private Diagnostic Clinic (PDC) : Sarcoma DCI Clinical Research Team
  • Duke Raleigh Hospital : Sarcoma DCI Clinical Research Team
  • Duke Regional Hospital : Sarcoma DCI Clinical Research Team
  • Duke University Health System : Sarcoma DCI Clinical Research Team
  • Duke Women's Cancer Care Raleigh (Macon Pond) : Sarcoma DCI Clinical Research Team
  • Johnston Health (Smithfield) : Sarcoma DCI Clinical Research Team
  • Maria Parham Health (Henderson) : Sarcoma DCI Clinical Research Team
  • Scotland Health Care System (Laurinburg) : Sarcoma DCI Clinical Research Team
  • Southeastern Regional Medical Center (Lumberton) : Sarcoma DCI Clinical Research Team
View this trial at ClinicalTrials.gov

STARTRK-2 for Advanced Solid Tumors with NTRK1/2/3, ROS1, or ALK Gene Rearrangements
Principal Investigator: Riedel, Richard
Protocol Number: PRO00078723

Age Group: Adult
Scope: National

Phase: II (Cancer Control)
Disease Site: Ill-Defined Sites

Contact: DCI Clinical Research Team, Sarcoma
Email:

What is the Condition Being Studied?
Solid tumor cancer with specific gene mutations
What is the Purpose of this Study?
We are doing this study to learn if the study drug (entrectinib) is safe and will work in patients with advanced cancer with a gene mutation.
Who Can Participate in the Study?
Adults diagnosed with solid tumor cancer that has a gene mutation (NTRK1/2/3, ROS1, or ALK gene rearrangement).
What is Involved?
If you choose to be in this study you will:
- Have blood drawn, and a possible tumor tissue biopsy
- Physical and eye exam
- Complete quality of life surveys
- Take study drug (entrectinib) by mouth every day
- Take part in this study until your disease worsens or your study doctor requests you to stop
Participating Institutions:
  • Duke University Health System : Sarcoma DCI Clinical Research Team
View this trial at ClinicalTrials.gov

A Phase 2 Randomized Controlled Trial of Neoadjuvant Pembrolizumab with Radiotherapy and Adjuvant Pembrolizumab in Patients with High-Risk, Localized Soft Tissue Sarcoma of the Extremity
Principal Investigator: Riedel, Richard
Protocol Number: PRO00081828

Age Group: Adult
Scope: National

Phase: II (Cancer Control)
Disease Site: Soft Tissue

Contact: DCI Clinical Research Team, Sarcoma
Email:

What is the Condition Being Studied?
Soft tissue sarcoma of the arms or legs
What is the Purpose of this Study?
We are doing this study to learn whether combining pembrolizumab with radiation therapy and surgery can prevent the growth and spread of cancer to other parts of the body.
Who Can Participate in the Study?
Adults who:
- Have a diagnosis of soft tissue sarcoma of the arms or legs
- Have not had prior chemotherapy, targeted small molecule therapy, or radiation therapy for their current sarcoma  
- Have not had radiation therapy (more than 20 Gy) to the site of the current sarcoma.

What is Involved?
If you join this study, you will   
Be randomly assigned (like the flip of a coin) to one of the two groups:
  
- Patients in Group 1 will get radiation plus a study drug called pembrolizumab by IV every 3 weeks for 3 cycles before surgery. After surgery, you could get up to 14 more cycles of pembrolizumab (up to one year after the start of treatment)  

- Patients in Group 2 will get radiation therapy and surgery alone (this is the standard of care for sarcoma). 
Participating Institutions:
  • Duke University Health System : Sarcoma DCI Clinical Research Team
View this trial at ClinicalTrials.gov

A Phase 1b/2 Dose-Escalation and Expansion Trial of NC-6300 (Nanoparticle Epirubicin) in Patients with Advanced Solid Tumors or Advanced, Metastatic, or Unresectable Soft Tissue Sarcoma
Principal Investigator: Riedel, Richard
Protocol Number: PRO00082899

Age Group: Adult
Scope: National

Phase: I/II (Cancer Control)
Disease Site: Soft Tissue

Contact: Duke Recruitment Innovation Center
Phone: 919.681.5698

What is the Condition Being Studied?
Advanced solid tumors or advanced, metastatic, or unresectable soft tissue sarcoma
What is the Purpose of this Study?
We are doing this study to find out how safe and effective a study drug called Nanoparticle Epirubicin (NC-6300) is for men and women with advanced cancer
Who Can Participate in the Study?
Adult men and women who have:  

Part 1: a diagnosis of advanced solid tumor, including sarcomas that are not responding to standard therapy  

Part 2: a diagnosis of advanced, unresectable or metastatic soft tissue sarcoma not eligible for curative treatment with surgery or radiation.
What is Involved?
This study is divided into two parts.   

Part 1 is looking for the best dose of a study drug called NC-6300 for people with solid tumors.  

Part 2 will look at the activity and safety of the drug when combined with Olaratumab in patients with soft tissue sarcoma.  

In Part 1, patients will receive an intravenous infusion of NC-6300 on day 1 of each 21-day cycle until they have bad side effects or their disease gets worse.  

In Part 2, patients will receive the best dose identified in Part 1 on day 1 of each 21 day cycle plus Olaratumuab on days 1 and 8 of each cycle until they have bad side effects or their disease gets worse.  

All patients will go through a screening period with physical exams, testing and questionnaires.  

While receiving the study drug, all patients will have testing on days 1, 8 and 15 of each cycle. 

Patients in Part 1 will also have several blood tests throughout the day on day 1 of each cycle.
Participating Institutions:
  • Duke University Health System : Sarcoma DCI Clinical Research Team
View this trial at ClinicalTrials.gov

UM1 10005 Atezolizumab (Sarcoma)
Principal Investigator: Abbruzzese, James
Protocol Number: PRO00082954

Age Group: Adult
Scope: National

Phase: II (Cancer Control)
Disease Site: Soft Tissue

Contact: DCI Clinical Research Team, Sarcoma
Email:

What is the Condition Being Studied?
Advanced alveolar soft part sarcoma 
What is the Purpose of this Study?
We are doing this study to test any good and bad effects of the study drug called atezolizumab.  
Who Can Participate in the Study?
Adults with advanced alveolar soft part sarcoma that is not curable by surgery and for which there is no standard treatment.  
What is Involved?
If you join this study you will:
-- Be given the study drug Atezolizumab by vein into your arm. This will take about 1 hour
-- Need to stay in the hospital for 2-3 hours after the first time you get the drug 
--This drug is given in cycles; each cycle involves one dose of study drug every 21 days (on same day of each cycle) until you experience unacceptable side effects or your tumor grows
Participating Institutions:
  • Duke University Health System : Sarcoma DCI Clinical Research Team
View this trial at ClinicalTrials.gov

UM1 10015 Trametinib (Epithelioid Hemangioendothelioma)
Principal Investigator: Abbruzzese, James
Protocol Number: PRO00083588

Age Group: Adult
Scope: National

Phase: II (Cancer Control)
Disease Site: Soft Tissue

Contact: DCI Clinical Research Team, Sarcoma
Email:

What is the Condition Being Studied?
Epithelioid hemangioendothelioma (EHE)
What is the Purpose of this Study?
We are doing this study is to test any good and bad effects of the study drug called trametinib in people with epithelioid hemangioendothelioma (EHE).
Who Can Participate in the Study?
Adult patients with epithelioid hemangioendothelioma (also called EHE), a rare type of cancer that is thought to develop from blood vessel cells. 
What is Involved?
If you join this study you will get the study drug trametinib.  

You will take a pill every day of each treatment cycle. A cycle is 28 days (4 weeks of treatment). 

This study has two parts.  Your doctor will inform you if you are in the first or second group.
-- Group 1 consists of the first 13 participants treated with trametinib. 
-- If the cancer shrinks by 30% or more in at least 1 of the patients, the study will enroll up to 14 more participants.
-- Group 2: consists of the next 14 participants to receive trametinib. 

Participating Institutions:
  • Duke University Health System : Sarcoma DCI Clinical Research Team
View this trial at ClinicalTrials.gov