47 Clinical Trials for Various Conditions
The researchers are doing this study is to find out whether ERAS-601 is a safe and effective treatment that causes few or mild side effects in people with advanced and progressing chordoma.
Chordoma
Primary Objective: 1. To determine objective response rate (ORR) according to RECIST v1.1 of pembrolizumab and high-dose pemetrexed in the treatment of patients with chordoma until disease progression. The OOR will be investigator assessed. Secondary Objectives: 1. To describe the adverse events associated with administering pembrolizumab and high-dose pemetrexed combination treatment. 2. To determine disease control rate based on imaging and overall survival. 3. To determine median PFS and PFS rates at 6, 9, 12, and 18 months. 4. To evaluate changes in volumetric tumor measurements based on imaging. 5. To determine the effects of combination treatment on quality of life, assessed by the EORTC-QLQ-C30 questionnaire. 6. To assess tumor evolution over time in patients with chordoma based on imaging, and molecular profiling. 7. To assess the pharmacodynamic effects of treatment in blood. Exploratory Objective: 1. To explore the relationship between molecular phenotype and patient response.
Chordomas, Chordoma
This is a multicenter, single arm, phase 2 study designed to evaluate the efficacy and safety of cetuximab for the treatment of advanced (unresectable)/metastatic, chordoma. The target patient population will be any chordoma patient 18 years of age with locally unresectable disease or metastatic disease.
Chordoma, Metastatic Chordoma, Unresectable Chordoma
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.
Chordoma
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.
Chordoma
QUILT 3.091 Chordoma Vaccine: Phase 1B/2 NANT Chordoma Vaccine vs Radiation in Subjects with Unresectable Chordoma.
Chordoma, Unresectable Malignant Neoplasm
This phase II trial studies how well nivolumab and relatlimab work in treating participants with chordoma that has spread to other places in the body. Monoclonal antibodies, such as nivolumab and relatlimab, may interfere with the ability of tumor cells to grow and spread.
Chordoma, Locally Advanced Chordoma, Metastatic Chordoma, Unresectable Chordoma
The goal of this study is to determine if the combination of BN-Brachyury plus radiation therapy can induce objective radiographic response rate (ORR) in patients, using a Simon 2-stage optimal design. In stage 1, a minimum of threshold of activity is needed to proceed to stage 2.
Chordoma
This phase I trial studies the side effects of nivolumab with or without stereotactic radiosurgery (SRS) in treating patients with chordoma that has come back or spread from where it started to other places in the body. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. It is not yet known whether giving nivolumab with or without stereotactic radiosurgery may work better in treating patients with chordoma.
Chordoma
This is a phase 2 clinical trial to determine whether the yeast-brachyury vaccine GI-6301 improves the effectiveness of radiation for patients with localized chordoma. Chordoma patients with inoperable or residual tumor who do not have metastases and are planning to be treated with definitive (\>70Gy) radiation were enrolled. Patients were randomized to receive radiation plus the vaccine or radiation plus a blinded placebo. The study compared the outcomes of patients treated with radiation with and without the vaccine to determine whether the vaccine can increase the chances of shrinking the tumor and/or preventing further tumor growth.
Chordoma
The objectives of this study are 1) To evaluate the feasibility and acute side effects of proton therapy for chordomas and chondrosarcomas and 2) To evaluate clinical outcomes and long term side effects of proton beam radiation for treatment of chordomas and chondrosarcomas.
Chordomas, Chondrosarcomas
The study drug, Nilotinib, is believed to slow down tumor growth by regulating a gene involved in cellular growth of chordoma cells. During this research study, subjects will also receive radiation therapy which is considered a standard treatment for advanced chordomas. It is hoped by adding nilotinib, the benefits of radiation therapy can be enhanced without adding significant toxicities. The purpose of this research study is to determine the safety of nilotinib when used in combination with radiation therapy, and the highest dose of nilotinib that can be given safely with radiation therapy.
Chordoma
This is a multi-center study to assess the safety and to determine the maximum tolerated dose of the combination of imatinib and LBH589 in patients with newly diagnosed and recurrent chordoma. For the recurrent population, those patients that do not require immediate surgical resection will be eligible. Patients will be treated with 4 cycles, followed by surgical resection if possible. If indicated, surgery may take place prior to the completion of 4 cycles.
Chordoma
The purpose of this study is to collect information from medical records to see what effects proton beam radiation has on cancer and analyze possible side effects.
Chordomas, Chondrosarcomas
Before radiation treatment is given to treat chordomas, CT and MRI scans are used to create a three dimensional picture of the tumor using x-rays. The CT and MRI scans are used to determine the size and location of the area that will receive radiation treatment. The purpose of this research study is to see if combining the images from the FMISO-PET scan and the CT and MRI scans in radiation treatment planning changes the size and location of the area that will receive radiation treatment when compared to planning the radiation treatment with CT and MRI scans alone.
Chordoma
The primary purpose of this study is to determine if the administration of a higher dose would decrease the chance of tumor recurrence, compared to the risk of tumor recurrence with a lower dose. Most of the treatment will be given protons, but participants may receive a small portion of treatment with x-rays, because less radiation is given to the skin with x-rays. This study uses two slightly different doses of radiation It is not clear at this time which of the dose levels is better.
Chordoma, Chondrosarcoma
The goal of this clinical research study is to learn if proton beam therapy, with or without photon beam radiation therapy, is effective in the treatment of skull base chordoma. The safety of this treatment will also be studied.
Chordoma
This pilot study, conducted by the National Cancer Institute and the Massachusetts General Hospital, will investigate genetic factors that contribute to the development of chordoma in people from some families. Chordoma is a very rare, potentially fatal, slow-growing bone tumor derived from remnants of embryonic material. This study will determine the feasibility of conducting a larger study aimed at identifying new families with multiple members affected by chordoma to study the genetic basis of the disease. English-speaking persons diagnosed with chordoma when they were 18 years of age or younger and who were treated at the Massachusetts General Hospital Department of Radiation Oncology between 1988 and the end of the study period may be eligible for this protocol. The age range of these patients is currently from about 5 months to 33 years. Patients (or parents of minor patients) will be mailed a packet with instructions for completing the following procedures at home: * Provide permission for researchers to obtain medical records relating to the patient's chordoma and any other serious medical conditions he or she has had, and to obtain a piece of the patient's stored tumor tissue. * Complete a questionnaire about the patient's close blood relatives, including parents, brothers, sisters, and any more distant relatives who have had chordoma or a cancer or tumor which started in the brain or spine. The questionnaire will also include demographic information, such as education, marital status, ethnicity, religion, and household income. * Collect two samples of cheek cells (only from patients 6 years and older). Patients' packets include instructions and materials for collecting the cells. Parents of children 6 to 9 years old will collect cells from the child's mouth using a sterile soft-bristled brush contained in a tube. They will brush the inside of the child's cheek with the brush for about 30 seconds and then place the brush back in the tube. They will repeat this procedure with a second brush. Patients 10 years of age and older will rinse their mouth for about 45 seconds with a mouthwash provided in their packets and then spit the mouthwash into a collection container. They will repeat the procedure several hours later. All participants will return the signed permission forms, questionnaires, and cheek cell samples to the researchers in a pre-addressed stamped envelope, which is also provided in the packet. ...
Chordoma
Chordoma is an uncommon (400 case/year in the U.S.) and potentially fatal bone tumor derived from remnants of embryonic notochord. It occurs primarily in the axial skeleton and has a mean age at diagnosis of 55 years, with a range from early childhood to over 70 years. This tumor usually presents at an advanced stage and the associated mortality is high due to local destruction and distant metastases. Chordoma is rare in African-Americans and is typically sporadic; there are few reports of these tumors arising congenitally or within members of the same family. Recently, we have identified and studied one large family in which 10 relatives in three generations have chordoma; the inheritance pattern suggests transmission of a mutation in an autosomal dominant gene. Using information from this family, we have tentatively napped this gene to the long arm of chromosome 7. To confirm this finding, and to fine map and clone the gene, we need to study additional chordoma families. In an effort to identify such families, we have developed collaborations with four SEER registries covering the populations of Detroit, Los Angeles, Iowa, and New Mexico. Each registry will identify all chordoma cases diagnosed since 1988 and invite them (or the next of kin of deceased cases) to participate in our study. Through 1997, the registries have identified a total of 140 chordoma cases, 96 of whom are living. The registries will invite these patients (or their next of kin) to participate in the study. The study components include completion of a self-administered personal and family medical history questionnaire, retrieval of medical records and pathology reports pertaining to chordoma, and collection of paraffin-embedded chordoma tissue and buccal mucosal cells for genetic studies. NCI will carry out all the data collection activities for the study subjects identified through the Detroit registry. NCI will also conduct the buccal cell collection component of the study for all patients identified by the other three registries. These three registries will carry out all other study activities on these patients/next of kin and will send the data and slides prepared from the paraffin blocks to NCI. NCI will analyze the questionnaire data to determine if any unusual patterns of cancers other than chordoma or other medical conditions appear to cluster in families of the chordoma patients. Selected members of any families with two or more relatives with chordoma will be invited to participate in a separate clinical and molecular study conducted at NIH to try to identify the chordoma gene. DNA from the buccal cells and tumor blocks from all other patients with "sporadic" chordoma identified through the registries (likely to comprise most patients) will not be studied until we or others have identified such a gene.
Chordoma
In this study the investigators will study the effects of neoadjuvant radiation therapy (RT), in the form of either proton therapy or stereotactic body radiation therapy (SBRT), on the Circulating tumor DNA (ctDNA), radiographic changes and radiomics, and the validity of these findings will be compared using the current gold standard- pathologic findings. The purpose of this work is to explore whether the biomarkers may be used diagnostically to better understand radiographic changes following RT. The investigators hypothesize that ctDNA levels in combination with imaging biomarkers identified through radiomics will be a sensitive and specific tool for predicting histopathologic response to RT.
Chordoma of Spine, Chordoma of Skull Base, Chordoma of Sacrum
Background: Chordoma is a rare, slow growing, often fatal bone cancer derived from remnants of the embryonic notochord. It occurs mostly in the axial skeleton (skull base, vertebrae, sacrum and coccyx), is more frequent in males than females, and has a median age at diagnosis of 58.5 years, with a wide age range. This typically sporadic tumor is often advanced at presentation, and mortality is high due to local recurrence or distant metastases. The usual treatment is surgery, followed by adjuvant radiation therapy. Chemotherapy has not had a significant treatment role. Reports of a small number of families worldwide with two or more relatives with chordoma support a role for susceptibility genes in chordoma etiology. Recently we determined that duplications of the T gene co-segregated with disease in four multiplex chordoma families. The T gene encodes brachyury, a tissue-specific transcription factor that is expressed in notochord cells and is essential for formation and maintenance of the notochord. Some of the other chordoma families that we studied did not have T-gene duplications; the aggregation of chordomas in these families may result from changes in other susceptibility genes or other types of mutations targeting the T gene. We are continuing gene identification studies of multiplex chordoma families at the NIH Clinical Center under protocol 78-C-0039. We also want to determine whether alterations in any identified chordoma susceptibility genes are associated with sporadic chordoma in the general population. Objectives: The major goal of this protocol is to identify sporadic chordoma patients willing to provide germline and tumor DNA for studies to determine the frequency of alterations in chordoma susceptibility genes. Our previous protocols with SEER and Massachusetts General Hospital to identify chordoma patients were limited to residents of specific geographic regions in the U.S. (2 states and 2 metropolitan areas) or to patients with pediatric skull base tumors. This protocol will enroll patients who more broadly represent the age, site and gender distributions of sporadic chordoma in the general U.S. population. Eligibility: Eligible patients are males and females in the U.S. with chordoma diagnosed at any age and at any primary site. Because we want to obtain saliva from all participants, eligibility is limited to patients who will be greater than or equal to age 6 years at the time of enrollment. Design: The study description and contacting information including an e-mail link to the study contact person will be posted on web sites of two chordoma support groups. We will mail study information to be given to patients to colleagues at major medical centers that treat chordoma. The components of the study will be carried out in subjects' homes using materials mailed to them. Up to 100 participants will: 1) complete a self-administered Personal and Family Medical History Questionnaire, 2) collect saliva using a saliva collection kit, and 3) provide permission to obtain medical/pathology records, and paraffin blocks or slides on each primary chordoma. Parents will serve as proxies for minor children. We will recontact patients who report chordoma in at least one blood relative. If we confirm the relative's chordoma diagnosis, we will invite the study subject and selected family members to participate in clinical and gene mapping studies under protocol 78-C-0039. We may also recontact study participants to tell them about any new studies on chordoma etiology. They can decide at that time whether they want to participate in them.
Genes, Sporadic Chordoma
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 cancer patients for combination treatment of TAEK-VAC-HerBy vaccine and therapeutic HER2 antibodies (trastuzumab). Patients in both stages will receive TAEK-VAC-HerBy intravenously, every three weeks, three administrations in total.
Chordoma, HER2-positive Breast Cancer
There are two types of external radiation treatments; proton beam and photon beam radiation. What type of therapy participants will receive will depend upon the location of their tumor. Standard treatment would involve receiving either proton or photon radiation delivered by a three dimensional (3-D) conformal radiation technique. 3-D conformal radiation therapy is a technique where the beams of radiation used in the treatment are shaped to match the tumor in order to avoid damaging the healthy surrounding tissue. Standard treatment also may include photon radiation delivered by intensity modulated (IMRT) technique. In this research study we are using an investigational technique to deliver proton radiation therapy called intensity modulated proton radiation treatment (IMPT) which is used to target cancer while sparing healthy tissue. With IMPT (and standard IMRT), radiation intensity can be turned down during the treatment. This control over the intensity of the radiation dose has the potential to provide accuracy and allows us to more safely increase the amount of radiation delivered to the tumor. This accuracy may potentially reduce side effects that patients would normally experience with 3-D proton radiation therapy. Surgery is often an important component of the treatment for these tumors and may be integrated with the IMPT.
Chordoma of Spine, Chordoma of Sacrum, Chordoma of Base of Skull, Chondrosarcoma of the Spine, Chondrosarcoma of the Sacrum
Hematopoietic stem cell transplantation can cure patients with blood cancer and other underlying diseases. αβ-T cell and B cell depletion has been introduced to decrease GVHD and PTLD and has demonstrated effectiveness for hematologic malignancies and non-malignant diseases additionally increasing the donor pool as to allow for haploidentical transplant to safely occur. While solid tumors can be highly chemotherapy sensitive, many remain resistant and require multimodalities of treatment. Immunotherapy has been developed to harness the immune system in fighting solid tumors, though not all have targeted effects. Some solid tumors are treated with autologous transplants; however, they do not always demonstrate an improved event free survival or overall survival. There has been evidence of the use of allogeneic stem cell transplants to provide a graft versus tumor effect, though studies remain limited. By utilizing αβ-T cell and B cell depletion for stem cell transplants and combining with zoledronic acid, the immune system may potentially be harnessed and enhanced to provide an improved graft versus tumor effect in relapsed/refractory solid tumors and promote an improved event-free survival and overall survival. This study will investigate the safety of treatment with a stem cell graft depleted of αβ-T cell and CD19+ B cells in combination with zoledronic acid in pediatric and young adult patients with select solid tumors, as well as whether this treatment improves survival rates in these patients.
Neuroblastoma, Rhabdomyosarcoma, Synovial Sarcoma, Peripheral Nerve Sheath Tumors, Clear Cell Sarcoma, Alveolar Soft Part Sarcoma, Desmoplastic Small Round Cell Tumor, Chordoma, Rhabdoid Tumor, Epithelioid Sarcoma, Myoepithelial Tumor, Osteosarcoma, Ewing Sarcoma
This research study involves a combination of three drugs given together as a possible treatment for malignant rhabdoid tumor, atypical teratoid rhabdoid tumor, epithelioid sarcoma, chordoma or other tumors that are deficient in one of two possible proteins, either INI-1 (SMARCB1) or SMARCA4. The names of the study drugs involved in this study are: * Tazemetostat (TAZVERIK) * Nivolumab (OPDIVO) * Ipilimumab (YERVOY)
Atypical Teratoid Rhabdoid Tumor, INI1 (SMARCB1)-deficient Primary CNS Malignant Tumors, SMARCA4-deficient Primary CNS Malignant Tumors, Malignant Rhabdoid Tumor (MRT), Rhabdoid Tumor of the Kidney (RTK), Epithelioid Sarcoma, Chordoma
This study compares carbon ion therapy, surgery, and proton therapy to determine if one has better disease control and fewer side effects. There are three types of radiation treatment used for pelvic bone sarcomas: surgery with or without photon/proton therapy, proton therapy alone, and carbon ion therapy alone. The purpose of this study is to compare quality of life among patients treated for pelvic bone sarcomas across the world, and to determine if carbon ion therapy improves quality of life compared to surgery and disease control compared with proton therapy.
Bone Sarcoma, Chondrosarcoma, Chordoma, Ewing Sarcoma of Bone, Pelvic Rhabdomyosarcoma
Forty patients with pancreatic cancer, sarcoma and carcinoma of breast will receive DNG64 intravenously at a dose of 1-4 x 10e11 colony forming units (cfu) or equivalent 1.0-6.0 x 10e10 RV copies per dose one to three times a week. DNG64 may be given alone or with one or more FDA approved cancer therapies/immunotherapies. Based on previous Phase 1/2 US based clinical studies, DNG64 does not suppress the bone marrow or cause 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, DNG64 will be continued regardless of CT, PET or MRI results if the patient has clinical benefit and does not have symptomatic disease progression.
Pancreatic Cancer, Osteosarcoma, MPNST (Malignant Peripheral Nerve Sheath Tumor), Chondrosarcoma, Soft Tissue Sarcoma, Chordoma, Sarcoma, Carcinoma of Breast
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.
Pituitary Tumor, Meningioma, Rathke Cleft Cysts, Chordoma, Chondrosarcoma, Craniopharyngioma, Encephalocele, Esthesioneuroblastoma
This study investigates the safety/toxicity and potential anti-tumor activity of sequential administration of nivolumab and escalating doses of the mammalian target of rapamycin (mTOR) inhibitor nab-rapamycin (ABI-009) in advanced Ewing's sarcoma, perivascular epithelioid cell tumor (PEComa), epithelioid sarcoma, desmoid tumor, chordoma, non-small cell lung cancer, small cell lung cancer, urothelial carcinoma, melanoma, renal cell carcinoma, squamous cell carcinoma of head and neck, hepatocellular carcinoma, classical Hodgkin's lymphoma, high microsatellite instability (MSI-H)/ mismatch repair deficient (dMMR) metastatic colorectal cancer, and tumors with genetic mutations sensitive to mTOR inhibitors.
Ewing Sarcoma, PEComa, Epithelioid Sarcoma, Desmoid Tumor, Chordoma, Non Small Cell Lung Cancer, Urothelial Carcinoma, Melanoma, Renal Cell Carcinoma, Squamous Cell Carcinoma, Hepatocellular Carcinoma, Classical Hodgkin Lymphoma, Colorectal Cancer, MTOR Activating Mutation
This research trial studies genes in tissue samples from younger and adolescent patients with soft tissue sarcomas. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors find better ways to treat cancer
Childhood Alveolar Soft-part Sarcoma, Childhood Angiosarcoma, Childhood Desmoplastic Small Round Cell Tumor, Childhood Epithelioid Sarcoma, Childhood Fibrosarcoma, Childhood Leiomyosarcoma, Childhood Liposarcoma, Childhood Malignant Mesenchymoma, Childhood Neurofibrosarcoma, Childhood Synovial Sarcoma, Chordoma, Desmoid Tumor, Metastatic Childhood Soft Tissue Sarcoma, Nonmetastatic Childhood Soft Tissue Sarcoma, Recurrent Childhood Soft Tissue Sarcoma