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/patient/studies/area12.html
MacMillan’s “Clinical Trials” http://www.macmillan.org.uk/Cancerinformation/Cancertreatment/Clinicaltrials/Clinicaltrials.aspx
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.
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 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 trail to evaluate the progression-fee 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 sarcome in 4 defined subgroups: liposarcoma, leiomyosarcoma, undifferentiated pleomorphic sarcoma and myxofobrpsarcoma, and other STS. For more information click here.
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 www.l-sarcomastudy.com or 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 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 over expressed 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: WChow@coh.org