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Sarcoma clinical trials

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NCT ID: NCT01882231 Terminated - Osteosarcoma Clinical Trials

Quantitative Imaging Biomarkers of Treatment Response in Osteosarcoma and Ewing Sarcoma

Start date: March 2013
Phase: N/A
Study type: Interventional

The objective of these studies is to use changes in 3 Tesla MRI measurements of tumor protein content, cell density, and microvessel perfusion, obtained before and after a single cycle of NAC, to predict eventual tumor response observed at the conclusion of NAC, within patients with osteosarcoma or Ewing Sarcoma.

NCT ID: NCT01879085 Completed - Sarcoma Clinical Trials

Study of Vorinostat in Combination With Gemcitabine and Docetaxel in Advanced Sarcoma

GemTax
Start date: September 24, 2013
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase Ib/II experimental, open-label, dose escalation, active treatment study designed to determine the safety, tolerability, and recommended dose of the combination. During the Phase 2 portion of the study, we will assess progression-free survival (PFS), overall survival (OS),overall response rate (ORR), correlative endpoints, DNA methylation measured by microarray, and expression level of the genes as measured by microarray

NCT ID: NCT01876303 Completed - Clinical trials for Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor (PNET)

Genetic Biomarkers in Saliva Samples From Patients With Ewing Sarcoma

Start date: December 2012
Phase: N/A
Study type: Observational

This clinical trial studies genetic biomarkers from saliva samples in patients with Ewing sarcoma. Studying samples of saliva from patients with cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.

NCT ID: NCT01875601 Completed - Sarcoma Clinical Trials

NK White Blood Cells and Interleukin in Children and Young Adults With Advanced Solid Tumors

Start date: June 11, 2013
Phase: Phase 1
Study type: Interventional

BACKGROUND: - Despite progress, some children and young adults with solid tumors still experience poor survival. - Activated NK cells potently kill autologous pediatric solid tumors, and clinical grade procedures are available to generate large numbers of activated NK cells for adoptive cell therapy. OBJECTIVES: - Primary objectives are: 1) to assess the feasibility of harvesting and expanding activated NK cells to meet escalating dose goals in Cohort A, 2) to assess the toxicity of infusing escalating doses of activated NK cells following lymphodepleting chemotherapy without rhIL15 (cohort A), and 3) to assess the toxicity of infusing NK activated cells with escalating doses of rhIL15 (cohort B) in pediatric patients with refractory malignant solid tumors. - Secondary objectives are: 1) to identify biologically active doses of activated autologous NK cells plus or minus rhIL15 by monitoring changes in NK cell number, phenotype and function, 2) to assess pharmacokinetics and immunogenicity of rhIL15 in a pediatric population, and 3) assess antitumor effects and changes in FDG-PET following administration of activated NK cells to lymphopenic hosts plus or minus rhIL15. 4) to evaluate saftey and efficacy of subsequent cycles of autologous NK cell infusions in patients in cohort A who received benefit from the first NK cell infusion. ELIGIBILITY: - Patients in Cohort A: 2-29 years with with refractory pediatric malignant solid tumors, Patients in Cohort B: 2-25 years with refractory pediatric malignant solid tumors. - Adequate performance status and organ function, recovered from toxic effects of prior therapy, no requirement for systemic corticosteroids and no history of allogeneic stem cell transplantation. DESIGN: - All patients receive pre-NK lymphodepleting chemotherapy with cyclophosphamide. - Cohort A receives escalating doses of activated autologous NK cells to identify feasibility of generating cells and tolerability, and potentially identify an MTD. - A1: 1x10(6) NK cells/kg - A2: 1 x 10(7) NK cells/kg - A3: 1 x 10(8) NK cells/kg - If feasibility and acceptable toxicity is demonstrated for all doses in Cohort A, patients enrolled on cohort B will receive activated autologous NK cells plus escalating doses of rhIL15 using the following schema: - B1: 1 x 10(7) NK cells/kg + rhIL15 0.25 mcg/kg/d IV x 10 - B2: 1 x 10(7) NK cells/kg + rhIL15 0.5 mcg/kg/d IV x 10 - B3: 1 x 10(7) NK cells/kg + rhIL15 1 mcg/kg/d IV x 10 - B4: 1 x 10(7) NK cells/kg + rhIL15 2 mcg/kg/d IV x 10 - Three patients will be enrolled at each dose level, with the dose level expanded to 6 if dose-limiting toxicity occurs. An expanded group of 12 patients will be treated at the highest tolerable dose level. DLT toxicity monitoring will continue for 21 days after the NK infusion, or 14 days after the last rhIL15 dose in Cohort B (whichever is later).

NCT ID: NCT01864109 Active, not recruiting - Clinical trials for Newly Diagnosed Ewing Sarcoma

Irinotecan and Temozolomide in Combination With Existing High Dose Alkylator Based Chemotherapy for Treatment of Patients With Newly Diagnosed Ewing Sarcoma

Start date: May 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to find out what effects, good and/or bad, the combination of irinotecan and temozolomide has on Ewing sarcoma. Irinotecan and temozolomide are chemotherapy drugs that are used very often to treat pediatric patients at MSKCC. The investigators have used these two drugs for many years to treat patients with Ewing sarcoma whose cancer has relapsed. For patients with newly diagnosed Ewing sarcoma the current standard of care at MSKCC is a five drug chemotherapy regimen in combination with surgery and/or radiation therapy. This standard regimen is called the EFT regimen. . Some patients with Ewing sarcoma do not have their cancer cured by the chemotherapy and surgery/radiation therapy. This study adds the chemotherapy drugs called irinotecan and temozolomide to the standard EFT regimen. The investigators are trying to improve the success of standard therapy by adding these drugs. The use of irinotecan and temozolomide in this study is experimental because they have not been used before in patients with newly diagnosed Ewing sarcoma. However the investigators have found these drugs to be effective in patients with relapsed Ewing sarcoma. It is not known if adding these two drugs will improve the outcomes of patients treated for Ewing sarcoma.

NCT ID: NCT01861951 Completed - Soft Tissue Sarcoma Clinical Trials

A Trial Comparing Two Medications as First Treatment in Elderly Patients With Metastatic or Advanced Soft Tissue Sarcoma

EPAZ
Start date: October 2012
Phase: Phase 2
Study type: Interventional

Patients with a locally advanced or metastatic (i.e., there are already metastases of the diagnosed tumor in the body outside the primary lesion) soft tissue sarcoma will be recruited for this study. The minimum age to enter the study is 60 years. Therapy with doxorubicin is the mainstay of palliative chemotherapy for these patients, which is associated with hematological toxicity and an increase of the infection rate. Pazopanib is known to rarely induce hematological toxicity or to trigger infection. We therefore assume that pazopanib exerts similar activity while decreasing neutropenia and neutropenic fever. Pazopanib is already approved in the U.S. and Europe for the treatment of advanced soft tissue sarcoma. Doxorubicin and pazopanib will be randomly allocated to either receive doxorubicin or pazopanib in a phase II clinical trial. The aim of this study is to measure the treatment effect (reduction in tumor size or tumor stabilization) for both drugs, as well as the survival rate, and the duration of tumor control by the different therapies. A further objective is to measure the quality of life by standardized questionnaires throughout the course of treatment.

NCT ID: NCT01858168 Active, not recruiting - Rhabdomyosarcoma Clinical Trials

Phase I Study of Olaparib and Temozolomide for Ewings Sarcoma or Rhabdoomyosarcoma

Start date: July 2013
Phase: Phase 1
Study type: Interventional

This research study is a Three arm Phase I clinical trial, which tests the safety of an investigational drug or combination of drugs and also tries to define the appropriate dose of the combination of investigational drugs to use for further studies. "Investigational" means that the combination of drugs is being studied. It also means that the FDA has not yet approved the combination of drugs for your type of cancer. Olaparib works by blocking the activity of a protein called poly (ADP-ribose) polymerase (PARP) which is involved in DNA repair. Cancer cells rely on PARP to repair their DNA and enable them to continue dividing. Olaparib has been used in research studies with other cancers. Information from those other research studies suggests that this drug may help to treat patients with Ewing's sarcoma. The investigational drug olaparib is not approved for any use outside of research studies. Temozolomide (Temodar) is approved by the FDA for the treatment of a type of brain tumor, glioblastoma. It has been studied in Ewing sarcoma in previous research studies. While it is not approved by the FDA for Ewing sarcoma, it is considered part of standard treatment for relapsed disease. Irinotecan is approved by the FDA for the treatment of gastrointestinal cancers. It has been studied in Ewing sarcoma in previous research studies. While it is not approved by the FDA for Ewing sarcoma, it is considered part of standard treatment for relapsed disease. Laboratory studies suggest that the combination of olaparib and temozolomide and/or irinotecan may help kill Ewing sarcoma or rhabdomyosarcoma cells. In this research study, the investigators are looking for the highest dose of the combination of olaparib and irinotecan and/or temozolomide that can be given safely. The investigators will also begin to collect information about the effects of the combination on Ewing sarcoma and rhabdomyosarcoma.

NCT ID: NCT01853345 Completed - Sarcoma Clinical Trials

iCAT for Recurrent/Refractory/HR Solid Tumors

Start date: August 2012
Phase: N/A
Study type: Observational [Patient Registry]

In this study tumor will be tested for cancer causing gene alterations such as mutations or copy number alterations. This is called tumor profiling. A panel of experts will review the tumor profiling results and determine whether there is a cancer-causing alteration present in the tumor. If there is, the experts will determine if there is a targeted drug available that could counteract this alteration. If there is an alteration identified and a targeted drug available the panel of experts will make an individualized treatment recommendation. The results of the tumor profiling and the individualized treatment recommendation can be shared with the primary oncologist.

NCT ID: NCT01851928 Completed - Ovarian Cancer Clinical Trials

Validation of a Nutrition Screening Tool

Start date: July 2011
Phase: N/A
Study type: Observational

The objective of this study is to evaluate the sensitivity and specificity of two nutrition screening tools to identify inpatients with malnutrition or at risk of malnutrition. The two tools are the Royal Marsden Abridged Adult Nutrition Screening Tool (AANST) and the Malnutrition Screening Tool (MST)[10] The tools will be compared with the currently accepted gold standard, Patient Generated Subjective Global Assessment (PG-SGA). Both screening tools are in the form of scored questionnaires and are suitable for electronic input. The ultimate objective is to select an adult inpatient nutrition screening tool with the highest sensitivity for future use in the oncology inpatient setting in order to allow prompt commencement of an appropriate nutrition care plan.

NCT ID: NCT01846520 Completed - Clinical trials for Psychosocial Effects of Cancer and Its Treatment

Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, Urologic and Lung Cancers

Start date: October 2013
Phase: N/A
Study type: Interventional

This randomized clinical trial studies the Family Caregiver Palliative Care Intervention in supporting caregivers of patients with stage II-IV gastrointestinal, gynecologic, urologic and lung cancers. Education and telephone counseling may reduce stress and improve the well-being and quality of life of caregivers of cancer patients.