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Neoplasms clinical trials

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NCT ID: NCT04099797 Recruiting - High Grade Glioma Clinical Trials

C7R-GD2.CAR T Cells for Patients With GD2-expressing Brain Tumors (GAIL-B)

Start date: February 3, 2020
Phase: Phase 1
Study type: Interventional

This study is for patients with diffuse midline glioma, high grade glioma, diffuse intrinsic pontine glioma, medulloblastoma, or another rare brain cancer that expresses GD2. Because there is no standard treatment at this time, patients are asked to volunteer in a gene transfer research study using special immune cells called T cells. T cells are a type of white blood cell that help the body fight infection. This research study combines two different ways of fighting cancer: antibodies and T cells. Both antibodies and T cells have been used to treat cancer patients. They have shown promise but have not been strong enough to cure most patients. Researchers have found from previous research that they can put a new antibody gene into T cells that will make them recognize cancer cells and kill them. GD2 is a protein found on several different cancers. Researchers testing brain cancer cells found that many of these cancers also have GD2 on their surface. In a study for neuroblastoma in children, a gene called a chimeric antigen receptor (CAR) was made from an antibody that recognizes GD2. This gene was put into the patients' own T cells and given back to 11 patients. The cells did grow for a while but started to disappear from the blood after 2 weeks. The researchers think that if T cells are able to last longer they may have a better chance of killing tumor cells. In this study, a new gene will be added to the GD2 T cells that can cause the cells to live longer. T cells need substances called cytokines to survive. The gene C7R has been added that gives the cells a constant supply of cytokine and helps them to survive for a longer period of time. In other studies using T cells researchers found that giving chemotherapy before the T cell infusion can improve the amount of time the T cells stay in the body and therefore the effect the T cells can have. This is called lymphodepletion and it will allow the T cells to expand and stay longer in the body and potentially kill cancer cells more effectively. After treating 11 patients, the largest safe dose of GD2-CAR T cells given in the vein (IV) was determined. Going forward, IV infusions will be combined with infusions directly into the brain through the Ommaya reservoir or programmable VP shunt. The goal is to find the largest safe dose of GD2-C7R T cells that can be administered in this way. The GD2.C7R T cells are an investigational product not approved by the FDA.

NCT ID: NCT04096911 Recruiting - Cervical Cancer Clinical Trials

Combination of PD-1 Monoclonal Antibody and HPV Vaccine in Patients With Cervical Cancer

Start date: July 31, 2019
Phase: Phase 2
Study type: Interventional

The investigators propose to evaluate the efficacy of the combination of Pd-1 Monoclonal Antibody and HPV Vaccine in the patients with cervical cancer who fails in or can not endure the standard treatment

NCT ID: NCT04094610 Recruiting - Lymphoma Clinical Trials

A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations

Start date: March 12, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Phase 1 will evaluate the safety and tolerability at different dose levels of repotrectinib in pediatric and young adult subjects with advanced or metastatic malignancies harboring anaplastic lymphoma kinase (ALK), receptor tyrosine kinase encoded by the gene ROS1 (ROS1), or neurotrophic receptor kinase genes encoding TRK kinase family (NTRK1-3) alterations to estimate the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) and select the Pediatric Recommended Phase 2 Dose (RP2D). Phase 2 will determine the anti-tumor activity of repotrectinib in pediatric and young adult subjects with advanced or metastatic malignancies harboring ROS1 or NTRK1-3 alterations.

NCT ID: NCT04093466 Recruiting - Clinical trials for Advanced Solid Tumor

A Phase 1 Study of CX1003 (Kanitinib) in Patients With Advanced Solid Tumors

Start date: April 27, 2020
Phase: Phase 1
Study type: Interventional

CX1003 is a novel multi-target tyrosine kinase inhibitor that is designed to primarily inhibit vascular endothelial growth factor receptor 2 (VEGFR2) and hepatocyte growth factor receptor (HGFR/MET). This study aimed to evaluate the safety, pharmacokinetics, and antitumor activity of CX1003 in patients with refractory advanced or metastatic solid tumors.

NCT ID: NCT04092673 Recruiting - Solid Tumor, Adult Clinical Trials

Study of eFT226 in Subjects With Selected Advanced Solid Tumor Malignancies

Zotatifin
Start date: October 25, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This clinical trial is a Phase 1-2, open-label, sequential-group, dose-escalation and cohort-expansion study evaluating the safety, pharmacokinetics (PK), pharmacodynamics, and antitumor activity of Zotatifin (eFT226) in subjects with selected advanced solid tumor malignancies.

NCT ID: NCT04086485 Recruiting - Clinical trials for Neuroendocrine Tumors

Lu-177-DOTATATE (Lutathera) in Combination With Olaparib in Inoperable Gastroenteropancreatico Neuroendocrine Tumors (GEP-NET)

Start date: October 3, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

Background: A neuroendocrine tumor is a rare type of tumor. It comes from body cells called neuroendocrine cells. Sometimes, these tumors develop in the gastrointestinal tract and pancreas. Researchers want to find out if a combination of drugs can shrink these tumors. Objective: To learn if people with certain neuroendocrine tumors can take a combination of 2 drugs, Lutathera and Olaparib, without having severe side effects, and if this treatment makes the tumors shrink. Eligibility: Adults 18 and older who have a neuroendocrine tumor in the pancreas or intestine that cannot be cured by surgery and has somatostatin receptors on the cells. Design: Participants will be screened under protocol 01-C-0129. They may have a tumor biopsy. Eligible participants will get Lutathera through an intravenous (IV) infusion every 8 weeks for 4 cycles. One cycle is 8 weeks. Each cycle includes a follow-up visit at week 4. For the IV, a small plastic tube is put into an arm vein. Participants will also take Olaparib by mouth twice a day for 4 weeks of each cycle. They will use a medicine diary to track the doses. During the study, participants will have physical exams. They will have blood and urine tests. They will fill out questionnaires about their general well-being and function. Their heart function will be tested. They will have scans of their chest, abdomen, and pelvis. One type of scan will use an IV infusion of a radioactive tracer. Participants will have a follow-up visit about 4 weeks after treatment ends. Then they will have follow-up visits every 12 weeks for 3 years. Then they will have yearly phone calls.

NCT ID: NCT04085185 Recruiting - Clinical trials for Advanced Malignancies

A Study Evaluating the Safety, Tolerability, and Initial Efficacy of IBI110 in Subjects With Advanced Malignant Tumors

Start date: December 4, 2019
Phase: Phase 1
Study type: Interventional

This is an open-label, dose escalation, Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy of IBI110 in subjects with advanced malignancies.

NCT ID: NCT04084249 Recruiting - Colorectal Cancer Clinical Trials

ctDNA-guided Surveillance for Stage III CRC, a Randomized Intervention Trial

Start date: January 1, 2020
Phase: N/A
Study type: Interventional

IMPROVE-IT2 is a randomized multicenter trial comparing the outcomes of ctDNA guided post-operative surveillance and standard-of-care CT-scan surveillance. The hypothesis of this study is that ctDNA guided post-operative surveillance combining ctDNA and radiological assessments could result in earlier detection of recurrent disease and identify more patients eligible for curative treatment.

NCT ID: NCT04084067 Recruiting - Solid Tumor Clinical Trials

Indocyanine Green (ICG) Guided Tumor Resection

Start date: February 7, 2020
Phase: Phase 1
Study type: Interventional

This is a study to assess the ability of Indocyanine Green (ICG) to identify neoplastic disease. For many pediatric solid tumors, complete resection of the primary site and/or metastatic deposits is critical for achieving a cure. An optimal intra-operative tool to help visualize tumor and its margins would be of benefit. ICG real-time fluorescence imaging is a technique being used increasingly in adults for this purpose. We propose to use it during surgery for pediatric malignancies. All patients with tumors that require localization for resection or biopsy of the tumor and/or metastatic lesions will be eligible. Primary Objective To assess the feasibility of Indocyanine Green (ICG)-mediated near-infrared (NIR) imagery to identify neoplastic disease during the conduct of surgery to resect neoplastic lesions in children and adolescents. NIR imaging will be done at the start of surgery to assess NIR-positivity of the lesion(s) and at the end of surgery to assess completeness of resection. Separate assessments will be made for the following different histologic categories: 1. Osteosarcoma 2. Ewing Sarcoma 3. Rhabdomyosarcoma (RMS) 4. Non-Rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS) 5. Neuroblastoma 6. Renal tumors (Only bilateral Wilms Tumor patients will be included.) 7. Metastatic pulmonary deposits 8. Liver tumors, lymphoma, other rare tumors, and nodules of unknown etiology Exploratory Objectives 1. To compare the ICG uptake by primary vs metastatic site and pre-treated (chemotherapy, radiation, or both) vs non-pre-treated. 2. Assess the sensitivity and specificity of NIR imagery to find additional lesions not identified by standard of care intraoperative inspection and tactile feedback. 3. Assess the sensitivity and specificity of NIR imagery to find additional lesions not identified on preoperative diagnostic imaging. 4. Assess the sensitivity and specificity of NIR imagery for identifying residual disease at the conclusion of a tumor resection.

NCT ID: NCT04083599 Recruiting - Melanoma Clinical Trials

GEN1042 Safety Trial and Anti-tumor Activity in Subjects With Malignant Solid Tumors

Start date: September 17, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

To evaluate the safety and anti-tumor activity of GEN1042 in patients with metastatic or locally advanced solid tumors.