The following links provide basic information about participating in clinical trials.
National Cancer Institute National Cancer Institute (NCI) “About Clinical Trials” http://www.cancer.gov/clinicaltrials
National Institute of Health (NIH) “About Clinical Trials” http://www.clinicaltrials.gov/ct/gui/info/resources
NIH’s Clinical Trial Search http://clinicaltrials.gov
Genetic Testing – An Opportunity for Sarcoma Patients Genetic testing has the potential to provide sarcoma patients with increased understanding of their disease and optimal treatment options. Currently there are many for-profit companies that will analyze individual’s DNA and provide information on disease risk and treatment options. These are usually “qualified” findings and recommendations and need to be interpreted and acted on carefully in conjunction with your physician and/or a genetic counselor. There are no agreed on standards for testing or for what biomarkers and genes should be analyzed. The Sarcoma Alliance does not endorse any of these companies or their findings and recommendations. 23andMe is one of these companies and provides DNA analysis for a fee but also has a research study to attempt to better understand genetic biomarkers for sarcoma. There is no charge for participating in their study but any individual findings should be discussed with your health care team.
23andMe Research Project While some researchers strive to understand sarcoma by studying tumor samples, 23andMe wants to work with the patient community to find genetic markers associated with the disease. These markers might help us predict how likely someone is to develop sarcoma or how well a particular treatment will work for a specific patient.
There’s strength in numbers. In order to draw meaningful conclusions, 23andMe hopes to find at least 1,000 qualified individuals who have or have had sarcoma. Using simple online questionnaires they will collect information regarding patients’ experiences, environments and responses to different therapies. They will then combine this information with genetic data to find patterns that will help to better understand the biology of sarcoma.
Join the 23andMe Sarcoma Community. If you are a sarcoma patient or survivor, we want to give you the opportunity to take an active role in sarcoma research. For complete information click https://www.23andme.com/sarcoma/. It’s FREE and you get access to the full features of 23andMe
Professional Organizations Sarcoma Alliance for Research through Collaboration (SARC) http://sarctrials.org/sarc-clinical-trials
Advocacy for Rare Diseases
Kakkis Everylife Foundation http://www.kakkis.org/
American Cancer Society’s “Clinical Trials” http://www.cancer.org/docroot/ETO/ETO_6.asp
Coalition of National Cancer Cooperative Group’s “Learn About Cancer Clinical Trials” http://www.cancertrialshelp.org/Icare_content/icMainContent.aspx?intAppMode=1
CenterWatch Oncology Clinical Trials Listing http://www.centerwatch.com/clinical-trials/listings/
MacMillan’s “Clinical Trials” https://www.macmillan.org.uk/information-and-support/treating/clinical-trials
Understanding the Informed Consent Process
Volunteering for a Clinical Trial Brochure http://store.centerwatch.com/p-137-volunteering-for-a-clinical-trial.aspx
European Organisation for Research and Treatment of Cancer (EORTC) Clinical Trials (click on “Protocols Database”) http://www.eortc.be
The following links are to specific clinical trials.
LSD1 Inhibitor Seclidemstat (SP-2577) in Patients with Relapsed/Refractory Ewing Sarcoma
This is an open label, single arm Phase 1 study to evaluate the safety of an orally administered targeted agent, seclidemstat (LSD1 inhibitor), in patients with relapsed or refractory Ewing sarcoma. Patients must have received at least one prior course of therapy for Ewing sarcoma. Groups of patients will receive increasingly higher doses of seclidemstat (dose escalation phase) until the highest tolerated dose has been found. Additional patients will then be enrolled at the highest tolerated dose (dose expansion phase). The primary objective is assessment of the safety and tolerability of seclidemstat.
For more information, please visit: https://clinicaltrials.gov/ct2/show/NCT03600649?term=salarius&draw=2&rank=2 (Identifier # NCT03600649)
Phase 1 trial of CBT-1 in Combination with Doxorubicin in Patients With Metastatic, Unresectable Sarcomas Who Previously Progressed on Doxorubicin
Many cells throughout our bodies naturally contain on their surface a class of proteins that actively
remove toxins from our cells during drug metabolism. Researchers have found that some cancer cells have a higher than normal amount of these proteins on their cell surfaces, allowing cancer cells to remove toxins (chemotherapy) from their cells more quickly. This can lead to drug resistance, as the tumor has developed a way to resist the effects of the drug by quickly removing it from cells before it can take its effect. Researchers believe that sarcoma patients whose tumors have not previously responded to doxorubicin (a common chemotherapy used in the treatment of sarcoma) may not be responding due to this drug resistance scenario. The drug in this trial blocks those cell surface proteins from being able to transport drugs out of the cancer cells, and may reverse drug resistance to doxorubicin.
For more information, please visit: https://clinicaltrials.gov/ct2/show/NCT03002805?term=CBT1 (Identifier # NCT03002805)
Phase 1/1b Study of MGCD516 in Patients with Advanced Cancer
All the cells in our bodies communicate by sending signals to one another through a type of molecule that exists on the surface of our cells called a receptor. One type of receptor that exists on all of our cells is called a receptor tyrosine kinase (RTK). The job of RTKs is to communicate signals to surrounding cells that will increase cell growth, cell survival, and cell migration (movement throughout our bodies). RTKs will naturally stop sending their signal when it is time for surrounding cells to stop growing. Many cancers grow because of a genetic mutation that causes the RTK signal to never turn off, so the cells keep multiplying and cause tumors to grow. The drug in this trial is taken orally and is designed to inhibit certain RTKs that are contributing to tumor growth by helping to turn off signals that otherwise will not turn off because of an existing mutation. This study is looking at patients with certain specific mutations, so the patient will be asked to provide tumor samples (either from surgery or biopsy) to test for these mutations.
For more information, please visit: https://clinicaltrials.gov/ct2/show/NCT02219711?term=NCT02219711 (Identifier # NCT02219711)
Phase 1b/2 Dose-Escalation and Expansion Trial of NC-6300 in Patients with Advanced Solid
Tumors or Soft Tissue Sarcoma
Targeted drug delivery is a method of delivering medication to a patient in a way that will increase the concentration of the drug in certain specific areas of the body more than others. A micelle is a group of molecules naturally produced by our bodies that come together to make an enclosed circle around another molecule in order to safely transport that molecule to somewhere else in the body. In this study, researchers have developed a micelle that will specifically transport the chemotherapy epirubicin into tumors cells only, allowing the chemotherapy to accumulate in tumor cells. This allows the chemotherapy to be delivered to the tumor over a longer period of time in order to increase its effect on the cancer. This therapy is also expected to decrease side effects because the drug is delivered very specifically to the tumor, avoiding toxicity in healthy cells.
For more information, please visit: https://clinicaltrials.gov/ct2/show/NCT03168061?term=NCT03168061 (Identifier # NCT03168061)
Phase 3 Trial of Anlotinib in Metastatic or Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma and Synovial Sarcoma (APROMISS)
This study evaluates the safety and efficacy of AL3818 (anlotinib) hydrochloride in the treatment of metastatic or advanced alveolar soft part sarcoma (ASPS), leiomyosarcoma (LMS), and synovial sarcoma (SS). All participants with ASPS will receive open-label AL3818. In participants with LMS or SS, AL3818 will be compared to IV dacarbazine. Two-thirds of the participants will receive AL3818, one-third of the participants will receive IV dacarbazine.
The Sarcoma Oncology Center in Southern California has created a shareable document with information about this study and contact information for their center for those who are interested or have questions. Anlotinib Clinical Trial PDF
For more information, please visit: https://clinicaltrials.gov/ct2/show/NCT03016819?term=NCT03016819&rank=1 (Identifier # NCT03016819)
A Randomized Phase 3, Multicenter, Open-Label Study Comparing TH-302 in Combination With Doxorubicin vs. Doxorubicin Alone in Subjects With Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma – Threshold Pharmaceuticals
The purpose of this study is to determine whether TH-302 in combination with Doxorubicin is safe and effective in the treatment of Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma.
Primary Outcome Measures:
- Efficacy of TH-302 in combination with doxorubicin [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Efficacy will be determined by overall survival in subjects with locally advanced unresectable or metastatic soft tissue sarcoma previously untreated with chemotherapy compared with doxorubicin alone
Secondary Outcome Measures:
- Safety of TH-302 in combination with doxorubicin in subjects with locally advanced unresectable or metastatic soft tissue sarcoma compared with doxorubicin alone [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
To investigate the pharmacokinetics of TH-302, Br-IPM, doxorubicin, and doxorubicinol in plasma
|Estimated Enrollment:||620 – Reached completion of target enrollment in 2013; no longer recruiting patients|
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||April 2015|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
For more information please visit: http://clinicaltrials.gov/ct2/show/NCT01440088?spons=Threshold&rank=16
A Randomized Trial of Pembrolizumab & Radiotherapy Versus Radiotherapy in High-Risk Soft Tissue Sarcoma of the Extremity (SU2C-SARC032)
This is a multicenter, randomized phase II trial with an initial safety run-in to test the safety and efficacy of neoadjuvant pembrolizumab with image-guided radiotherapy and adjuvant pembrolizumab compared to radiation therapy alone in patients with clinically localized extremity soft tissue sarcoma at high risk for developing metastatic disease (tumor size > 5 cm, intermediate- to high-grade; approximately 50% risk for distant disease at 2 years). Histologies will be limited to undifferentiated pleomorphic sarcoma and dedifferentiated/pleomorphic liposarcoma based on preliminary data from SARC028. Other terms for undifferentiated pleomorphic sarcoma may include, but are not limited to. pleomorphic undifferentiated sarcoma, unclassified spindle cell sarcoma, spindle cell sarcoma not otherwise specified, pleomorphic spindle cell sarcoma, pleomorphic fibroblastic sarcoma, undifferentiated high-grade pleomorphic sarcoma, pleomorphicsarcoma with prominent inflammation, pleomorphic sarcoma with giant cells, malignant fibrous histiocytoma (including storiform-pleomorphic and inflammatory subtypes), fibrosarcoma, and myxofibrosarcoma (located deep to the fascia in muscle). Radiation therapy with three cycles of pembrolizumab will be administered as neoadjuvant therapy for patients randomized to the experimental arm. These patients will also receive up to fourteen cycles of adjuvant pembrolizumab after surgical resection. Patients in the standard of care arm will receive neoadjuvant radiotherapy (50 Gy in 25 fractions) followed by surgical resection as in RTOG 0630.
For more information, please visit: https://clinicaltrials.gov/ct2/show/NCT03092323 (Identifier # NCT03092323) and https://progress.standuptocancer.org/trials/sarcoma
SAINT: Phase 1&2 study of safety/efficacy using Trabectedin, Ipilimumab and Nivolumab as First
Line Treatment for Advanced Soft Tissue Sarcoma
This study uses three treatments that have already been FDA approved to treat cancer, although they are not typically all used at the same time. Of the three drugs used in this study, two of them are considered immunotherapy, which means they use different ways to increase the ability of your immune system to fight cancer, and the third is a chemotherapy drug that itself fights and kills cancer cells. Researchers believe that delivering these drugs simultaneously will have a synergistic effect, causing each drug to work better than it normally would on its own.
For more information, please visit: https://clinicaltrials.gov/ct2/show/NCT03138161?term=NCT03138161 (Identifier # NCT03138161)
Study to Evaluate Apatinib (Also Known as Rivoceranib) Plus Nivolumab in Patients with
Unresectable or Metastatic Cancer
Our immune systems are extremely effective in ridding our bodies of anything foreign that may cause disease. These cells need to have an “off-switch” so that when the foreign entity has been destroyed by our immune system, our immune system stops fighting and doesn’t start also destroying healthy cells. The reason that cancer grows in our bodies is because cancer has evolved over time to find ways to hide itself, making the cancer invisible to the cells in our immune system. One way it does this is by producing a special molecule on the surface of tumor cells that effectively turn-off our immune cells so that they do not fight the cancer, thus allowing the cancer to continue to grow. Nivolumab is a molecule designed to block the “switch” so it cannot be turned off by cancer cells, allowing your own immune system to effectively fight the cancer. Apatinib is a drug that works by blocking tumor cell growth. This study uses a combination of apatinib and nivolumab, which researchers believe will increase the effect of nivolumab by simultaneously slowing down the growth of the cancer which our immune cells destroy existing tumor cells.
For more information, please visit: https://clinicaltrials.gov/ct2/show/NCT03396211?term=NCT03396211 (Identifier # NCT03396211)
A Study of the Safety and Efficacy of the Combination of Gemcitabine and Docetaxel with MORAb-004 in Metastatic Soft Tissue Sarcoma Morphotek is conducting this phase II trial to evaluate the progression-free survival (PFS) of subjects treated with the combination of gemcitabine and docetaxel plus MORAb-004 versus gemcitabine and docetaxel plus placebo in subjects with metastatic soft tissue sarcoma in 4 defined subgroups: liposarcoma, leiomyosarcoma, undifferentiated pleomorphic sarcoma and myxofibrosarcoma, and other STS. For more information view the PDF.
Trabectedin or Dacarbazine – Janssen Research & Development, L.L.C.
A Study of Trabectedin or Dacarbazine for the Treatment of Patients with Advanced Liposarcoma or Leiomyosarcoma Janssen Research & Development, L.L.C. is conducting a Phase 3 clinical trial for trabectedin or dacarbazine in patients with liposarcoma or leiomyosarcoma. This is a randomized (study drug assigned by chance), open-label (all patients and study staff know the identity of the assigned study drug), active-controlled (comparing to a different drug used for the same condition), parallel-group (different treatment groups continue with separate treatments throughout the study), multicenter study. This study will be divided into three phases, screening, treatment, and follow-up. During screening, potential patients will be assessed for study eligibility after providing signed informed consent. During the treatment phase, patients will receive study drug once every 3 weeks, until disease progression or signs of toxicity. Assessments will be performed to evaluate the effectiveness of the drug, and patient safety will be monitored. During the follow-up phase, after the last dose of study drug, clinical outcomes for patients will be evaluated. Trabectedin will be administered at a dose of 1.5 mg/m2 through a catheter into a large vein as a 24-hour intravenous (IV) infusion, once every 3 weeks, until disease progression or signs of toxicity. Dacarbazine will be administered at a dose of 1.0 g/m2 as a 20 to 120-minute infusion, once every 3 weeks, until disease progression or signs of toxicity. For more information on this study, please visit http://www.clinicaltrials.gov (Identifier # NCT01343277).
Sarcoma Vacine – MabVax Therapeutics, Inc
MabVax Therapeutics, Inc. is conducting a Phase II clinical trial testing a novel vaccine for sarcoma. This clinical trial is for individuals who have recently been diagnosed with metastatic sarcoma (Stage IV) or who were previously diagnosed, recently underwent surgery, and are now disease free. The investigational vaccine is designed to instruct the immune system to destroy any sarcoma cells that remain in the body after surgery The investigational vaccine will be compared to non-specific immune therapy and is given as an outpatient treatment with the goal of preventing or delaying sarcoma recurrence.
Initial entry criteria include: being 18 year of age or older, having a diagnosis of metastatic sarcoma that can or already has been completely removed by surgery and receiving your first does of investigational vaccine within 8 weeks of having surgery.
If interested in learning more and to see if you qualify for further evaluation, please visit us at http://www.clinicaltrialspotlight.com
Pazopanib – GlaxoSmithKline GlaxoSmithKline is actively recruiting participants for an international Phase III, double-blind trial of pazopanib in patients with soft tissue sarcoma. Pazopanib is an oral angiogenesis inhibitor targeting VEGFR, PDGFR and cKit. Eligible subjects may have received a maximum of 4 prior lines of systemic therapies (including up to 2 combination regimens) for advanced disease, including an anthracycline-based regimen; (neo)adjuvant/maintenance treatments are not counted against this criterion. Other primary inclusion criteria include confirmed disease progression, metastatic and not only locally advanced disease and measurable disease according to RECIST criteria. No liposarcomas (all subtypes), Ewing tumors or GIST tumors are eligible. See Clintrials.gov Identifier NCT00753688 for complete eligibility criteria and participating centres.
Trivalent Vaccine for Sarcoma Trial – MabVac Therapeutics Inc. MabVax Therapeutics is actively recruiting patients for a Phase 2 sarcoma vaccine trial who have recently been treated for metastatic sarcoma and whose status is “No Evidence of Disease” or NED. The patients in the study will be randomized to receive either a vaccine that is combined with an immune system stimulant or the immune system stimulant alone. The immune system stimulant is called OPT-821 and is an immunological booster. If the trivalent vaccine can stimulate the patient’s immune system to develop antibodies which recognize and target the GM2, GD2 and GM3 sugars that are overexpressed on the surface of most sarcomas, then the patient’s antibodies could attack and kill any remaining sarcoma cells potentially preventing the recurrence of sarcoma. For more information about the trial, please visit the clinical trial overview.
http://www.clinicaltrials.gov/ct/show/NCT00233948?order=1 Investigator: Warren Chow, MD Email: [email protected]