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Clinical Trials

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Introduction

This section will provide links to various Clinical Trials that may be of interest to patients with desmoplastic small round cell tumors. Please check the links, the dates of the trial, eligibility, and contact information thoroughly.

As with any treatment for DSRCT some of these drugs may work for certain patients depending upon body type, age, health circumstances, disease stage, and probably just luck.

Locations for the clinical trials may be varied or may be localized, please check with your physician or call directly. You may be able to find a clinical trial closer to where you live. Ask.

Clinical Trials may be conducted by government health agencies such as NIH, researchers affiliated with a hospital or university medical program, independent researchers, or private industry.

Please remember that in Clinical Trials, especially Phase 1 trials that you may not be receiving the best dosage of drug (you may even receive a placebo) to treat your disease. Clinical Trials should be undertaken at the advice and guidance of a qualified oncologist who is interested in your specific well being. The Trial may not be effective for your needs. Consider also that Clinical Trials will take up valuable time. However, a Clinical Trial will also offer new drugs that have the potential to help a DSRCT patient and all patients with DSRCT. At the moment chemotherapy options are limited for this patient population. More drugs are needed that will work for DSRCT and the only way to find more drugs that work is through a Clinical Trial. It is a serious risk, but even with conventional chemotherapy there seems to come a time when the drugs stop working. So DSRCT patients are always at risk. Investigate the Clinical Trial thoroughly to make sure you understand the risks and the potential benefits. Even if the drug fails remember that will be an added bit of information in the advancement of finding cures and treatment options for DSRCT.

  • Important Definitions:

Phase 1 Clinical Trials - First study that determines how the drugs will affect human beings, the side effects associated with increasing doses, and to begin the process of evaluating the drugs effectiveness; may include healthy participants and/or patients. Phase 1 trials generally can include a large group of people. Phase 1 trials are investigational and patients should remember that they may be in a cohort that does not receive the full benefit of the drugs or treatments (you can ask specifically about this - as it is rare for advanced cancer patients to be given a placebo). Phase 1 Clinical Trials may not benefit you individually, but may give clues in the overall scheme of trying to find drugs that work for DSRCT.


Dana Farber Cancer Institute: Entering a Clinical Trial: Is it Right for You? - Download video that explains clinical trials simply.

Trials Specifically for Desmoplastic Small Round Cell Tumor

1. Irinotecan, Temozolomide and Bevacizumab in Combination With Existing High Dose Alkylator Based Chemotherapy for Treatment of Newly Diagnosed Patients With Desmoplastic Small Round Cell Tumor Memorial Sloan-Kettering Cancer Center August 25, 2010

2. Phase 1 Intraperitoneal Radioimmunotherapy With 131I-8H9 for Patients With Desmoplastic Small Round Cell Tumors and Other Solid Tumors Involving the Peritoneum Memorial Sloan-Kettering Cancer Center, April 2010

Phase 1 Clinical Trials

1. Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Refractory, Recurrent, or Advanced CNS or Leptomeningeal Cancer -This study is currently recruiting patients. Patients receive iodine I 131 monoclonal antibody 8H9 (which has been identified in DSRCT). Verified by National Cancer Institute (NCI) April 22, 2010

2. Intraperitoneal Hyperthermic Perfusion With Oxaliplatin in Treating Patients With Stage IV Peritoneal Cancer Due to Appendix Cancer or Colorectal Cancer - This study is ongoing, but not recruiting participants. Verified by National Cancer Institute (NCI) Feb 2009

3. Continuous Hyperthermic Peritoneal Perfusion (CHPP) With Cisplatin for Children With Abdominal Cancer - This study is ongoing, but not recruiting participants. Verified by M.D. Anderson Cancer Center July 2010

4. Drug Interaction Study of Sorafenib and Rapamycin in Advanced Malignacies - This study has been completed. Verified by University of Chicago January 27, 2010

5. Study of ZIO-201 in Advanced Sarcoma - Phase 1/Phase 2. The study of safety of Isophosphoramide Mustard (IPM) in the treatment of advanced sarcoma. A Phase IB/IIA Study of the Saftey and Activity of Intravenous Isophosporamide Mustard (ZIO-201) in Patients With Advanced Sarcoma This study is ongoing, but not recruiting participants. Verified by ZIOPHARM Sept 2009

6. CCI-779 and EKB-569 in Treating Patients With Advanced Solid Tumors - This study has been completed. Verified by National Cancer Institute (NCI) Feb 2009 CCI-779 (Temsirolimus)

7. One Time Injection of Bacteria to Treat Solid Tumors That Have Not Responded to Standard Therapy - This study has been suspended. Verified by Sidney Kimmel Comprehensive Cancer Center 2008


8. Safety Study of IPI-504 in Patients With Gastrointestinal Stromal Tumors (GIST) or Soft Tissue Sarcomas (STS) - (HSP90)IPI-504 is a novel, water-soluble analog of 17-AAG and a potent inhibitor of Hsp90. This study is ongoing, but not recruiting participants. Verified by Infinity Pharmaceuticals April 2008

9. Phase 1 Study Of Anti-IGF-IR CP-751,871 In Patients With Solid Tumors - This study is ongoing, but not recruiting participants. Verified by Pfizer August 2010. Inclusion criteris: Diagnosis of rhabmyosarcoma or PNET/Ewing's sarcoma family tumor, including synovial sarcoma and desmoplastic round small cell tumors

10. A Phase I Trial Of CCI-779 In Combination With EKB-569, An EGFR Inhibitor, In Patients With Solid Tumors (Cohort B) -This study has been completed. Verified by National Cancer Institute (NCI) Feb 2009. Temsirolimus (Rapamycin derivative)

11. MP470 in Treating Patients With Unresectable or Metastatic Solid Tumor or Lymphoma - This study has been terminated. March 2010. Company sponsoring the trial is SuperGen which has an affiliation with the Stehlin Foundation. Principle investigator is Anthony Tolcher.

Phase II Clinical Trials

1. Chemotherapy Followed by Donor Peripheral Stem Cell Transplantation in Treating Young Patients With Recurrent Sarcoma - This study is ongoing, but not recruiting participants. Verified by National Cancer Institute (NCI) July 2010.

2. Ecteinascidin 743 in Treating Young Patients With Recurrent or Refractory Soft Tissue Sarcoma or Ewing's Family of Tumors - [Yondelis] This study is ongoing, but not recruiting participants. Verified by National Cancer Institute (NCI) April 2010.

3. a Multicenter Clinical Trial for the Treatment of Children and Adolescents With Soft Tissue Sarcoma Stage 4 This study has been completed. Verified by Cooperative Weichteilsarkom Gruppe April 2009

4. Ixabepilone in Treating Young Patients With Refractory Solid Tumors This study has been completed. Verified by National Cancer Institute (NCI) January 2010

5. A Pilot Study of Tumor Cell Vaccine for High-Risk Solid Tumor Patients Following Stem Cell Transplantation This study is ongoing, but not recruiting participants. Verified by University of Michigan Cancer Center Feb 2010

6. Iodine I 131 Monoclonal Antibody 3F8 in Treating Patients With Central Nervous System Cancer or Leptomeningeal Cancer This study is currently recruiting participants. Verified by National Cancer Institute (NCI) Aug 2010

7. Irinotecan in Treating Patients With Newly Diagnosed Ewing's Sarcoma This study is currently recruiting patients. Verified by National Cancer Institute (NCI) November 2006

8. Sorafenib in Treating Patients With Soft Tissue Sarcomas This study is currently recruiting patients. Verified by National Cancer Institute (NCI) November 2006

9. Study of Vinorelbine and Cyclofosfamide Among Patients With Refractory Tumours or in Relapse This study is currently recruiting patients. Verified by Institut Gustave Roussy September 2006

10. Study of ZIO-201 in Advanced SarcomaThis study is currently recruiting patients. (Intravenous Isophosporamide Mustard). Verified by ZIOPHARM February 2007

11. Imatinib Mesylate in Patients With Refractory Desmoplastic Small Round Cell Tumors - This study has been completed. Verified by Novartis April 2010.

12. Ecteinascidin 743 in Treating Young Patients With Recurrent or Refractory Soft Tissue Sarcoma or Ewing's Family of Tumors -A Phase II Study Of Trabectedin (ET-743, Yondelis®) in Children With Recurrent Rhabdomyosarcoma, Ewing Sarcoma, or Nonrhabdomyosarcomatous Soft Tissue Sarcoma. - This study is not yet open for patient recruitment. Verified by National Cancer Institute (NCI) February 2007

13. Cytarabine in Treating Young Patients With Recurrent or Refractory Ewing's Sarcoma - Phase II Trial of Intermediate-Dose Cytarabine to Modulate EWS/FLI for Children and Young Adults With Recurrent or Refractory Ewing Sarcoma - This study is currently recruiting patients. Verified by National Cancer Institute (NCI) June 2007Cytarabine

14. Trial of Dasatinib in Advanced Sarcomas - This study is not yet open for patient recruitment. Verified by Sarcoma Alliance for Research through Collaboration April 2007

15. Sunitinib in Treating Patients With Metastatic, Locally Advanced, or Locally Recurrent Sarcomas - This study is currently recruiting patients. Verified by National Cancer Institute (NCI) May 2007

16. Etoposide, Cyclophosphamide, Thalidomide, Celecoxib, and Fenofibrate in Treating Young Patients With Relapsed or Progressive Cancer - This study is currently recruiting patients. Verified by National Cancer Institute (NCI) April 2007. Anti-Angiogenic Chemotherapy, the idea is to keep tumors from growing by cutting off blood supply. A new drug may be added periodically. Considered a maintenance treatment.

17. BI 2536 in Treating Patients With Recurrent or Metastatic Solid Tumors studying the side effects and how well BI 2536 works in treating patients with recurrent or metastatic solid tumors. Verified by National Cancer Institute (NCI) September 2007. This study is currently recruiting participants.

18. Safety and Efficacy Study of REOLYSIN® in the Treatment of Bone and Soft Tissue Sarcomas Metastatic to the Lung This study is currently recruiting participants. Verified by Oncolytics Biotech July 2007. Intravenous REOLYSIN® (Wild-Type Reovirus) in the Treatment of Patients With Bone and Soft Tissue Sarcomas Metastatic to the Lung.

Phase III Clinical Trials

1.Doxorubicin With or Without Ifosfamide and Pegfilgrastim in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma - Adults. This study is currently recruiting patients. Verified by National Cancer Institute (NCI) November 2006.

2. Study to Provide Access to Trabectedin in Patients With Soft Tissue Sarcoma Who Have Persistent or Recurrent Disease and Who Are Not Expected to Benefit From Currently Available Standard of Care - (Yondelis) 18 Years and above. This study is currently recruiting patients. Verified by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. May 2007


No Longer Recruiting

1. 17-N-Allylamino-17-Demethoxygeldanamycin (17-AAG) in Treating Young Patients With Recurrent or Refractory Leukemia or Solid Tumors -No longer recruiting patients

2. Phase II Trial of Imatinib Mesylate (Gleevec) in Therapy of Ewing's Family of Tumors and Desmoplastic Small Round Cell Tumors No longer recruiting

3. Phase II Study of AP23573, An MTOR Inhibitor, in Patients with Advanced Sarcoma - No longer recruiting

4. Arsenic Trioxide in Treating Patients With Advanced Neuroblastoma or Other Childhood Solid Tumors - This study has been suspended. Verified by National Cancer Institute (NCI) April 2007

5. Mitomycin as a Hyperthermic Peritoneal Perfusion in Treating Patients With Malignant Ascites - This study is no longer recruiting patients.

6. Vinblastine, Celecoxib, and Combination Chemotherapy in Treating Patients With Newly-Diagnosed Metastatic Ewing's Sarcoma Family of Tumors This study has been suspended. Verified by National Cancer Institute (NCI) June 2007

7. FR901228 (Depsipeptide) in Treating Patients With Metastatic or Unresectable Soft Tissue Sarcoma Verified by National Cancer Institute (NCI) March 2007. This study has been suspended.

Fast Tract Status

Clinical Trial Results

As Clinical trials come to a close data will start drifting in and often end up as reports at Entrez Pubmed. You can conduct an online search looking for this information or go to Entrez Pubmed to search their database:

Entrez Pubmed - National Library of Medicine has over 17 million publications.

You can find documented ongoing studies about DSRCT with most reports based on information gathered during a Clinical Trial.

DSRCT Publications

You can also look up companies that have conducted Clinical trials and the results:

Clinical Study Results

Find Clinical Trials

There may be some duplications of the above information. You should be able to follow the link to this site and specifically check what clinical trials are offered at each research facility.

1. US National Institute of Health - A searchable database of past and current clinical trials available.

2. City of Hope Clinical Trials Online -A searchable database of all clinical trials available at this facility.

3. University of Florida Shands Cancer Center - A searchable database of all clinical trials available at this facility. Requires registration.

4. Center Watch: Oncology

5. Cancertrialshelp.org

6. Fred Hutchinson Cancer Research Center -Searchable database

7. MSKCC Soft Tissue Sarcoma Trials

8. CureSeach Clinical Trials -Searchable database for children and young people with cancer.

9. Liddy Shriver Initiative Clinical Trials - Updated regularly. Good source when looking specifically for sarcoma Clinical Trials. Includes trials for adults and children.

10. Cancer Therapy and Research Center in San Antonio Texas - A not-for-profit, freestanding, multidisciplinary cancer center.

DSRCT References

Contact: dsrct.wiki@gmail.com

Disclaimer: The information of this page is not intended to be an endorsement for any clinical trial, drug, or treatment method. Please check with your health care professional about whether these clinical trials are beneficial in your own situation.

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