View clinical trials related to Neoplasms.
Filter by:To investigate the dosage of RRx-001 by the subcutaneous route.
Multicenter randomized phase II study, double-blind, comparing Taxotere plus curcumin versus Taxotere plus placebo combination in first-line treatment of prostate cancer metastatic castration resistant. Assess time to progression (time to progression) of metastatic disease (from first day of treatment in the trial).
Cervical cancer is a leading cause of mortality among women in developing countries. A key factor has been the failure to achieve good coverage. The development in the last years of HPV-DNA based tests has changed the scenario, because it combines a high performance to detect disease with a reduction of screening frequency. Through self-testing, HPV testing has the potential of reducing social and health service barriers faced by women to access screening. This study is carried out in Jujuy, one of the Argentinian provinces with highest cervical cancer mortality rates and where HPV testing has been introduced as a primary screening test for all women attending public health sector. The study was conducted between July 2012-December 2013, and supported by the Argentinean National Cancer Institute. The protocol was approved by the institutional review committees of the Ministry of Health of Jujuy. This trial is a randomized by population clusters study that aims to assess the effectiveness of self-testing to increase coverage. The aims of this study are: a) to assess the self-test effectiveness to increase the participation of women in screening programs, b) to assess the self-test acceptability by women, c) to assess HPV self-test effectiveness measurement for the detection of CIN2+ lesions against cytology in primary screening. An overall number of 200 community health workers (CHWs) from the Primary Health Care System (PHCS) of Jujuy will be randomized into two groups that will be named Self-test Group (ST) and Conventional Sample Group (CS): 1. ST Group: CHWs will invite eligible women of their area to choose between doing a self-test or having a conventional sample taken by a health professional of the closest health care center. 2. CS Group: CHWs will invite eligible women in their area to have a conventional sample taken by a health care professional of the nearest health care center. In order to measure the self-test relative sensitivity against cytology to detect CIN2+ in primary screening, all the women in the Self-test Group who have decided to do the self-test and all the women of 30 years of age and older that were screened with cytology by the provincial program for the prevention of cervical cancer in 2011 will be considered. A database built specifically for the study will be used; it will hold the list of eligible women to participate in the study. The records of women of 30 years of age and older residing in the areas included in the study will be imported from the PHCS databases. In addition, the data surveyed by the study will be uploaded: randomization Group, presence of the woman at home during the CHW's visit, agreement to participate in the study, realization of self-test (in the corresponding group), and if appropriate, reasons for not doing the self-test. Lastly, the HPV Test realization will be uploaded importing the data on SITAM, (link of data done as from the identity card number). Data Analysis Self-test acceptability: Acceptability is defined as the number of women accepting the self-test against the number of women offered the option between the self-test and the conventional sample (proportion of women accepting the self-test). The acceptability in this population will be estimated as the average of acceptabilities calculated by CHW, as to control the impact of the CHWs on acceptability and reach an appropriate variance estimate. Besides, the variability introduced by the CHWs on acceptability will be studied and the results obtained by male and female CHWs will be compared, as well as those obtained by the CHWs in rural and urban areas. Self-test effectiveness to enhance participation of women in screening and diagnosis: There will be a comparison of the percentage of women that did the HPV test in the Self-test group and the Conventional sample group. Three different coverage indicators will be considered for every CHW. These will be defined as the number of women screened within the field work regarding: 1. The number of women reached by the CHW who accepted participating in the study. 2. The number of eligible women for that CHW (regardless of whether the CHW was able to contact them or not). The effect of the strategy (offering the self-test option against promotion of the conventional sample) will be estimated for each one of the coverage measures using a means difference test or a non-parametric test for independent samples. CIN 2+ detection rate: The effectiveness of the HPV Self-test against screening cytology to detect CIN2+ will be estimated as the detection rates difference and as the detection rates ratio. In addition, there will be a comparison of the CIN2+ detection rate in the group of women who did the self-test against the total number of women in the province of Jujuy that were tested for HPV (conventional sample strategy + triage Pap test) until December 2012.
This phase I/II trial studies the side effects and best dose of adavosertib and irinotecan hydrochloride in treating younger patients with solid tumors that have come back (relapsed) or that have not responded to standard therapy (refractory). Adavosertib and irinotecan hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
The goal of this clinical research study is to find the highest tolerable dose of the combination of regorafenib and cetuximab that can be given to patients with advanced solid tumors. The safety and effectiveness of this drug combination will also be studied.
The purpose of this study is to assess the efficacy of rTMS over primary motor cortex in patients suffering from malignant visceral pain. Thirty four patients were included in the study. They are divided randomly into 2 groups using closed envelop as real rTMS group and sham group. Real rTMS over the hand area of motor cortex (20 Hz, 10 trains with inter train interval 30 second with total pulses 2000, intensity 80% of motor threshold) every day for ten consecutive days (5 days/week) and the coil elevated and angled away from the head as sham stimulation. Patients were evaluated by verbal descriptor scale (VDS), visual analog scale (VAS), and Hamilton rating scale for depression (HAM-D) at the baseline, after 1st, 5th, 10th session, 15 day and 1 month after end of sessions. Serum human dynorphin (Dyn) level was measured at baseline, 5th and 10th session.
This is an open-label, multicenter, Phase I study to evaluate the safety, tolerability, and PK of escalating doses of DLYE5953A administered to patients with incurable, locally advanced, or metastatic solid malignancy that has progressed on standard therapy. The Phase I study consists of two stages: Stage 1 dose-escalation and Stage 2 expansion in selected patients. In Stage 1, a 3 + 3 dose-escalation design will be used to examine the safety, tolerability, and PK of increasing doses of DLYE5953A. In Stage 2, patients will be enrolled to further characterize the safety, tolerability, and PK of the proposed dose and schedule for future studies.
The purpose of this study is to evaluate the safety and pharmacokinetics of enfortumab vedotin as well as assess the immunogenicity and antitumor activity in subjects with metastatic urothelial cancer and other malignant solid tumors that express Nectin-4.
This multicenter, non-randomized, open-label study will evaluate the efficacy and safety of six treatment regimens in participants with advanced solid tumors for whom therapies that will convey clinical benefit are not available and/or are not suitable options per the treating physician's judgment.
This will be an open-label, single agent, multi-institutional phase Ib/II study of ACY-1215 for the treatment of patients with relapsed or refractory lymphoid malignancies. The target population will include patients with histologically confirmed relapsed or refractory non-Hodgkin's lymphoma or Hodgkin's lymphoma, with an expansion cohort of patients with mantle cell lymphoma. The phase Ib will be conducted to determine the safety and tolerability of two dosing schedules of ACY-1215 monotherapy in patients with lymphoid malignancies. Patients will be accrued simultaneously to two dose cohorts (Arm A and Arm B) of ACY-1215. Selection into each cohort will occur by alternation. All patients will take the prescribed dose of ACY-1215 orally for 28 consecutive days. Patients enrolled into Arm A will take ACY-1215 160 mg daily (QD), whereas patients enrolled into Arm B will take ACY-1215 160 mg twice daily (BID). ACY-1215 will be supplied as a liquid for oral administration (PO). Each dose will be administered at least 1 hour after ingestion of food followed by at least 4 ounces of water. Patients will be instructed not to ingest food or other oral medication for at least 2 hours after each ACY-1215 dose. Frequency in phase II will be determined based on Phase Ib results.