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Chordoma clinical trials

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NCT ID: NCT04832620 Recruiting - Clinical trials for Magnetic Resonance Imaging

Image Assisted Optimization of Proton Radiation Therapy in Chordomas and Chondrosarcomas

CHIPT
Start date: February 2, 2021
Phase:
Study type: Observational

Rationale: Chordomas and chondrosarcomas located in the axial skeleton are malignant neoplasms of bone. These tumors share the same clinical challenges, as the effect of the disease is more a function of their local aggressiveness than their tendency to metastasize (20% metastasize). The local aggressive behavior can cause debilitating morbidity and mortality by destruction of nearby located critical neurovascular structures. Imaging has, in addition to histopathology, a role in diagnosis and in guiding (neo)adjuvant and definitive treatment. Despite the low sensitivity to radiotherapy, proton radiotherapy has been successfully used as an adjunct to resection or as definitive treatment for aggressive chordomas and chondrosarcomas, making it a standard indication for proton therapy in the Netherlands. Chordomas and chondrosarcomas consist, especially after previous therapy, of non-viable and viable tumor components. Identification of these viable components by functional imaging is important to determine the effect of previous therapy, as change in total tumor volume occurs more than 200 days after change of functional imaging parameters. Objective: The main objective of this study is to determine if functional MRI parameters change within 6 months, and earlier than volumetric changes after start of proton beam therapy. This would allow timely differentiation between affected and unaffected (viable) tumor components, which can be used for therapy adjustment. Secondary objectives: Determine which set of parameters (PET-CT and secondary MRI) can predict clinical outcome (tumor specific mortality, development of metastases, morbidity secondary to tumor activity and morbidity secondary to treatment); determine what type of imaging can accurately identify viable tumor nodules relative to critical anatomical structures; improving understanding of relevance of changing imaging parameters by correlating these with resected tumor. Study design: Prospective cohort study Study population: LUMC patients diagnosed with primary or recurrent chordoma or chondrosarcoma in the axial skeleton. A number of 20 new patients per year is expected. Main study parameters: Volumetric and functional MR imaging parameters including permeability parameters. Secondary parameters are generated by PET-CT (SUV, MTV and TLG), MR (perfusion, permeability and diffusion), therapy (proton beam dose mapping, surgery) and clinical outcome. End points are disease specific survival, progression free survival (including development of metastases), side effects of treatment, and functional outcome (see CRF). In patients who are treated with surgical resection following neo-adjuvant therapy, the surgical specimen will be correlated with imaging findings. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Treatment and clinical management will not be affected in this study, thus the additional burden, risks, and benefits associated with participation in this study are minimal. Two extra MRI and one PET-CT examination will be planned during proton therapy.

NCT ID: NCT04486820 Completed - Chordoma Clinical Trials

Immunohistochemical Study of Chordomas to Improve Their Diagnosis and Prognosis Care

CHORDOMES
Start date: April 1, 2020
Phase:
Study type: Observational

Chordomas are very rare malignant tumors, chemo-resistant with high propensity for recurrence. The role of immunotherapy in these patients remains largely unexplored while PD-L1 and CD8 status in the micro-environment of chordomas is basically not known. Similarly, this tumor often poses diagnostic difficulties due to its resemblance with metastasis or chondrosarcoma, thus, it would be useful to know the expression status of factors used during the work-up of metastatic or mesenchymal tumors, like CDX2, INSM1 and FOXA1, which remains unknown for chordomas. Thus, the aim of the study is to explore PD-L1, CD8, CDX2, INSM1 and FOXA1 expression in a series of chordomas and compare it with clinico-pathological and prognostic features.

NCT ID: NCT04416568 Recruiting - Epithelioid Sarcoma Clinical Trials

Study of Nivolumab and Ipilimumab in Children and Young Adults With INI1-Negative Cancers

Start date: August 14, 2020
Phase: Phase 2
Study type: Interventional

This clinical trial is studying two immunotherapy drugs (nivolumab and ipilimumab) given together as a possible treatment for INI1-negative tumors.

NCT ID: NCT04246671 Active, not recruiting - Clinical trials for HER2-positive Breast Cancer

TAEK-VAC-HerBy Vaccine for Brachyury and HER2 Expressing Cancer

Start date: August 10, 2020
Phase: Phase 1
Study type: Interventional

A Phase 1 open label trial of intravenous administration of TAEK-VAC-HerBy vaccine in patients with advanced brachyury and/or HER2- expressing cancer. The study will be completed in 2 stages. In Stage 1 patients will be enrolled and treated according to a 3+3 dose escalation scheme. Up to 4 dose levels will be explored to determine the recommended dose of TAEK-VAC-HerBy for Stage 2 of the trial. Stage 2 will enroll either chordoma patients for treatment with TAEK-VAC-HerBy alone, or HER2- positive breast and gastric/gastroesophageal junction cancer patients for combination treatment of TAEK-VAC-HerBy vaccine and therapeutic HER2 antibodies (trastuzumab, pertuzumab). Patients in both stages will receive TAEK-VAC-HerBy intravenously, every three weeks, three administrations in total.

NCT ID: NCT04091295 Available - Pancreatic Cancer Clinical Trials

Expanded Access for DeltaRex-G for Osteosarcoma, Chondrosarcoma, Soft Tissue Sarcoma, Pancreas and Breast Cancer

Start date: n/a
Phase:
Study type: Expanded Access

Forty patients with osteosarcoma, chondrosarcoma, soft tissue sarcoma, pancreas and breast cancer will receive DeltaRex-G intravenously at a dose of 1-4 x 10e11 colony forming units (cfu) or equivalent 0.6-1.8 x 10e10 RV copies per dose one to three times a week. DeltaRex-G may be given alone or with one or more FDA approved cancer therapies/immunotherapies. Based on previous Phase 1/2 US based clinical studies, DeltaRex-G does not suppress the bone marrow or cause serious organ dysfunction, and enhanced immune cell trafficking in tumors may cause the tumors to appear larger or new lesions to appear on CT, PET or MRI. Further, tumor stabilization/regression/remission may occur later during the treatment period. Therefore, DeltaRex-G will be continued regardless of CT, PET or MRI results if the patient has clinical benefit and does not have symptomatic disease progression.

NCT ID: NCT04087902 Recruiting - Meningioma Clinical Trials

Long-Term Longitudinal QoL in Patients Undergoing EEA

Start date: July 16, 2019
Phase:
Study type: Observational

This is a prospective longitudinal study to access postoperative 2-year quality of life in patients who undergo endonasal endoscopic approach surgeries of the skull base.

NCT ID: NCT04042597 Recruiting - Quality of Life Clinical Trials

Anlotinib Hydrochloride Versus Imatinib Mesylate in Locally Advanced, Unresectable or Metastatic Chordoma

CSSG-03
Start date: July 18, 2019
Phase: Phase 2
Study type: Interventional

For local relapse not amenable to reasonable curative surgery or for those with metastatic chordoma, chemotherapy is recognised as inactive. The major study drug is the small molecular tyrosine kinase inhibitors targeted at the stem cell factor receptor (KIT) and the platelet-derived growth factor receptors (PDGFRA and PDGFRB), eg. imatinib. Anlotinib is a novel tyrosine kinase inhibitor targeting both at VEGFR-2, -3 and PDGFRA and PDGFRB with high affinity, which also showed broad antitumor activity against EGFR and so on. Thus this multicenter, two-armed phase II trial of PKUPH-sarcoma 05 intended to investigate the efficacy and safety of anlotinib versus imatinib on advanced chordoma.

NCT ID: NCT03955042 Completed - Chordoma Clinical Trials

Pemetrexed for the Treatment of Chordoma

Start date: September 6, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study is to test the safety and tolerability of pemetrexed administered to people with chordoma. Other purposes of this study are to: - find out side effects (good and bad) of pemetrexed; - learn more about how pemetrexed might affect the growth of cancer cells; - evaluate tumor characteristics by collecting tumor tissue samples if available; - look at biomarkers (biochemical features that can be used to measure the progress of disease or the effects of a drug) in blood and cerebrospinal fluid if available.

NCT ID: NCT03910465 Recruiting - Chordoma Clinical Trials

Children and Adults With Chordoma

Start date: April 16, 2019
Phase:
Study type: Observational

Background: Chordoma is a rare type of bone cancer. It occurs in the skull base or spine. Researchers want to study people with chordoma in different ways. They hope this will help them design better future treatments and supportive care studies for this disease. Objective: To learn more about chordoma by looking at its clinical course, how it appears on imagine scans, and how it responds to therapies and treatments. Eligibility: People ages 2 and older with chordoma who are enrolled in NCI protocol 19-C-0016 Design: Participants will be screened with their medical history. Participants will have a visit to examine their disease. This will include: - Physical exam - Neurologic exam - CT scan and MRI: Participants will lie on a table. The table will slide into a machine. The machine will take pictures of the body. Participants will have other tests every 6-12 months: - Smell test - Surveys to assess their emotional, physical, and behavioral well-being and needs - Cognitive function tests Participants or their home doctors will be contacted every 6 12 months. They will be asked to provide information about their disease. This could include test results and imaging evaluations. Some participants may be asked to come to the clinic for more visits.

NCT ID: NCT03874455 No longer available - Clinical trials for Renal Cell Carcinoma

Tazemetostat Expanded Access Program for Adults With Solid Tumors

Start date: n/a
Phase:
Study type: Expanded Access

Patients with a diagnosis listed under "conditions" below are eligible to be considered for the EAP. These conditions must be serious or life-threatening at the time of enrollment and appropriate, comparable, or satisfactory alternative treatments must have been tried without clinical success. Patients with conditions not listed under "conditions" below are not eligible for the tazemetostat EAP.