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Neoplasms clinical trials

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NCT ID: NCT02564536 Withdrawn - Clinical trials for Myelodysplastic Syndromes

Pacritinib in Combination With Low Dose Decitabine in Intermediate-High Risk Myelofibrosis or Myeloproliferative Neoplasm (MPN)/Myelodysplastic Syndrome (MDS)

Start date: June 2017
Phase: Phase 1
Study type: Interventional

For the first 28 day cycle, all patients will be treated with single agent pacritinib at 200 mg twice daily. The investigators chose this starting dose based on the previous three phase I studies of pacritinib as a single agent which showed that the maximum tolerated dose (MTD) to be 500 mg, and subsequently, the dose of 400 mg daily was recommended for the phase II studies. Recently, the results of the phase III PERSIST-1 trial comparing pacritinib to best available therapy (BAT) in patients with MF was reported at the 2015 American Society of Clinical Oncology (ASCO) annual meeting. Pacritinib was found to be significantly more effective than BAT at reducing spleen volume at 24 weeks of therapy and improving constitutional symptoms. Low dose decitabine has demonstrated depletion of DNMT1 in normal hematopoietic stem cells (HSC) without cytotoxicity and subcutaneous (SC) instead of intravenous (IV) administration may avoid high peak levels that can cause apoptosis. Furthermore, the low toxicity associated with low dose decitabine would allow for more frequent (1 to 3 times weekly) administration of the drug which would catch more cells in S-phase via greater exposure time. Based on these findings, a starting dose of decitabine 5 mg/m2 SC twice weekly should be well tolerated and effective in patients with MF and MPN/MDS syndromes when combined with pacritinib 400 mg daily.

NCT ID: NCT02548715 Withdrawn - Neoplasms Clinical Trials

Levothyroxine Treatment for Subclinical Hypothyroidism After Head and Neck Surgery

LSHT
Start date: July 2015
Phase: Phase 2/Phase 3
Study type: Interventional

Patients that require treatment for cancers of the head and neck often require a combination of surgery and/or radiation and chemotherapy. Hypothyroidism is one of the most common complications, and has been associated with post-operative complications such as wound healing problems, fistula formation, and decreased quality of life and survival. Several studies have examined hypothyroidism after radiation to the head and neck, but few have examined this after non-thyroid head and neck surgery. Head and neck resection is theorized to devascularize the thyroid, thus resulting in post-operative hypothyroidism. Synthroid is a synthetic thyroid hormone often used in cases of patients with proven hypothyroidism and after surgical thyroid removal. It's use has been in effect and studied for over fifty years. Treatment algorithms for hypothyroidism are well published. However, treatment of subclinical hypothyroidism (elevated TSH with normal or near-normal T3/T4) is controversial. The rate of subclinical hypothyroidism after non-thyroid head and neck surgery is high (up to 20%), and is associated with post-operative complications as noted above. Therefore the investigators propose a double blinded randomized controlled trial comparing outcomes of patients that develop subclinical hypothyroidism after head and neck surgery, who are given a standardized dose of synthroid treatment versus those treated with placebo. The main outcomes to be examined are post-operative complications (wound healing issues, fistula formation), survival, and quality of life measures.

NCT ID: NCT02540135 Withdrawn - Clinical trials for Glioblastoma Multiforme

Fluorescein vs. iMRI in Resection of Malignant High Grade Glioma

Start date: March 1, 2015
Phase: N/A
Study type: Interventional

This study plans to learn more about if fluorescein with intraoperative Magnetic Resonance Imaging (MRI) is as good as intraoperative MRI (iMRI) alone in detecting the presence of tumor tissue during surgery. Both fluorescein and intraoperative MRI have been studied and routinely used to aid the neurosurgeon in distinguishing normal brain from tumor, helping the neurosurgeon to safely resect more tumor tissue during surgery. This study will enroll patients with malignant high grade glioma who are going to have a surgery to remove their brain tumor. For half of the patients, fluorescein and intraoperative MRI will be used together during surgery. For half of the patients, only intraoperative MRI will be used during surgery. iMRI is used as final verification of complete, safe resection in both arms.

NCT ID: NCT02487459 Withdrawn - Clinical trials for Hematologic Malignancies

Safety Study of Gene Modified Donor T-Cells in Adults With Advanced Hematologic Malignancies

Start date: July 2016
Phase: Phase 1
Study type: Interventional

This is an open-label, non-randomized study to evaluate the safety of two planned infusions of BPX-501 T cells after partially mismatched, related (haploidentical) HSCT in adults with hematologic malignancies.

NCT ID: NCT02458040 Withdrawn - Neoplasms Clinical Trials

Clinical Benefit of Genetic Biomarkers for Guiding Treatment Decisions in Oncology Drugs

Start date: May 2015
Phase:
Study type: Observational

This study is a meta-epidemiological study which aim is to quantify the clinical benefit of the biomarker-based strategy compared to conventional strategy across all drugs with such a strategy.

NCT ID: NCT02439723 Withdrawn - Clinical trials for Metastatic Solid Malignancies

Effects of LBM and PPIs on Pharmacokinetics and Safety of Regorafenib (BAY 73-4506) in Cancer Patients

Start date: March 2016
Phase: Phase 1
Study type: Interventional

The FDA and Health Canada have approved regorafenib at a daily dose of 160mg for the treatment of metastatic colorectal cancer and gastrointestinal stromal cancer; however, the 160 mg dose is not well tolerated by patients, especially women. The purpose of this study is to determine if lean body mass and acidity in the intestinal tract impact how regorafenib is absorbed into the bloodstream and then broken down and removed from the body. This may explain the side effects experienced at the 160 mg dose, especially by women, and inform regorafenib dosing in the future.

NCT ID: NCT02432612 Withdrawn - Advanced Cancer Clinical Trials

A Study to Assess the Pharmacokinetic (PK) Properties of Sativex® in Patients With Advanced Cancer

Start date: October 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the pharmacokinetics (PK) of a single oromucosal dose of Sativex in subjects with advanced cancer currently on background Step III opioid therapy.

NCT ID: NCT02430649 Withdrawn - Prostatic Neoplasms Clinical Trials

Irreversible Electroporation(IRE) For Unresectable Prostatic Neoplasms

IRE
Start date: January 1, 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Prostatic Neoplasms.

NCT ID: NCT02382068 Withdrawn - Malignant Neoplasm Clinical Trials

Dexamethasone in Preventing Hearing Loss in Patients Receiving Cisplatin

Start date: August 2014
Phase: N/A
Study type: Interventional

This randomized pilot clinical trial studies dexamethasone in preventing hearing loss in patients receiving cisplatin. Injecting a steroid, such as dexamethasone, behind the eardrum before chemotherapy may help protect against cisplatin-associated hearing loss.

NCT ID: NCT02376413 Withdrawn - Clinical trials for Local Recurrence of Malignant Tumor of Breast

Oncoplastic Breast-conserving Surgery in Non-metastatic Breast Cancer Patients

Start date: March 2015
Phase: N/A
Study type: Observational

Breast-conserving surgery (BCS) is the traditional surgical treatment for early-stage breast cancer patients. There are evidences indicating that oncoplastic-BCS (displacement technique) could improve cosmetic outcomes and/or quality of life, and has similar oncological safety as traditional BCS does. However, there are no prospective trial comparing oncoplastic-BCS vs. traditional BCS in terms of cosmetic outcomes and oncological safety. In this study, the investigators are going to address this issue by assigning patients into traditional and oncoplastic-BCS group, based on their preference.