ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00580970
Conditions: Prostate Cancer
Keywords: prostate cancer radiation therapy lovastatin rectal injury
Sponsor: Virginia Commonwealth University
Start date: 2007-04-01; Completion date: 2015-08-01
Enrollment: 73 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Lovastatin may protect against late effects of radiation therapy in patients with prostate cancer

Detailed description:
Oral lovastatin will be given at the dose of 20 mg/day with evening meal beginning on the first day of external beam radiation therapy (external beam alone or external beam followed by brachytherapy) or on the first day of brachytherapy (brachytherapy alone or brachytherapy followed by external beam radiotherapy) and continue for 12 months.

Arms: arm 1: Lovastatin (20-80 mg/d) was started on day 1 of radiation and continued for 12 months. Patients were followed for an additional 12 months. Lovastatin once per day for 1 year. After the implant, they are asked to return for checkups (study visits 4-13) 4 weeks, 8 weeks, 4 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months and 24 months after the procedure. At 8 weeks, 4 months, 6 months, 9 months and 12 months, will also have a blood test to check their liver.
Interventions: intervention 1: lovastatin
Intervention descriptions: intervention 1: The HMG-coA reductase inhibitor used in this study will be lovastatin. Dosage: 20 mg/d PO with evening meal. Patients on a higher dose of lovastatin at the time of study entry may continue at that dose level; for patients switching to lovastatin, the dose will be at the discretion of the prescribing physician, but must be at least 20 mg/day.Schedule: begin on the first day of external beam radiation therapy (external beam alone or external beam followed by brachytherapy) or on the day of brachytherapy (brachytherapy alone or brachytherapy followed by external beam radiotherapy) and continue for 12 months. Patients or their third party payers will be expected to cover the cost of the drug.

Protocol documents:
Clinical trial NCT00582816
Conditions: Leukemia Solid Tumors
Keywords: Recurrent or Refractory Leukemia or Solid Tumors in Pediatrics
Sponsor: University of Wisconsin, Madison
Start date: 2008-08-01; Completion date: 2015-08-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will assess the feasibility of utilizing a reduced intensity conditioning regimen, in the setting of haploidentical transplantation, for patients with recurrent acute lymphoblastic leukemia (ALL), AML and high risk or refractory solid tumors. In addition, the feasibility and safety of administering post-transplant NK cell infusions will be evaluated. Data obtained from this study will help determine the efficacy of allogeneic HSCT in the treatment of pediatric sarcomas and add to the small body of literature utilizing haploidentical HSCT to treat acute leukemia in pediatric patients. This study will also further elucidate the role of NK cells in mediating a graft vs. tumor effect in allogeneic HSCT. The main benefit to society is that this study will explore a novel therapy for children with highly refractory cancer who are felt to be incurable with conventional approaches. If feasibility is demonstrated, and there is evidence of anti-tumor activity, then this will open up a new area of clinical research to better define the efficacy of this approach for specific childhood malignancies.

Detailed description:

Arms: arm 1: patients will undergo a standard pre-transplant evaluation, but will also have blood drawn to evaluate their HLA class I killer immunoglobulin-like receptor (KIR) ligand typing. Parents will undergo KIR genotyping and phenotyping, and a donor will be selected based on which parent shows the greatest degree of KIR receptor-ligand mismatching. Once the donor has been selected he/she will undergo a peripheral blood stem cell (PBSC) collection utilizing G-CSF and GM-CSF for stem cell mobilization. The PBSC collection will be performed utilizing standard procedures. The PBSC will then be processed in the UW BMT Laboratory in order to deplete the graft of T cells. This will be accomplished using the CliniMACS cell separation system. T cell depletion is a standard procedure for patients receiving haploidentical stem cell grafts. The resulting stem cell product will be analyzed for T cell, stem cell and NK cell content.
Interventions: intervention 1: Clinimacs Cell Separation System intervention 2: conditioning chemotherapy intervention 3: DLI
Intervention descriptions: intervention 1: Depletion of T-cells intervention 2: Methylprednisolone, Equine ATG, Cyclosporine, Fludarabine, Melphalan, Thiotepa and Rituximab. intervention 3: NK Cell selected DLI

Protocol documents:
Clinical trial NCT00671437
Conditions: Carcinoma, Squamous Cell
Keywords: squamous cell carcinoma of the head and neck
Sponsor: Washington University School of Medicine
Start date: 2008-06-01; Completion date: 2015-08-01
Enrollment: 42 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to collect data and evaluate how the tumor is broken down in response to standard of care cetuximab treatment by evaluating the FDG-PET/CT scans, toxicity, see how well the FDG-PET/CT scans predict response to treatment and survival.

Detailed description:
Primary Endpoint

To compare the SUV (standardized uptake value) at up to three target tumor sites as assessed by FDG-PET/CT of eligible patients at baseline and then after eight weeks of treatment with cetuximab.

Secondary Endpoints

* To determine the overall tumor metabolic response (complete metabolic response, partial metabolic response, stable metabolic disease or progressive metabolic disease \[CMR, PMR, SMD, or PMD\]) to eight weeks of scheduled weekly doses of cetuximab as assessed by FDG-PET/CT performed at baseline and then after therapy.
* To correlate the overall tumor metabolic response (CMR, PMR, SMD, or PMD) as assessed by FDG-PET/CT with the anatomic tumor response rate (complete response, partial response, stable disease or progressive disease \[CR, PR, SD, or PD\]) by RECIST criteria as assessed by CT and clinical examination performed after eight weeks of scheduled weekly doses of cetuximab.
* To correlate the overall tumor metabolic response (CMR, PMR, SMD, or PMD) as assessed by FDG-PET/CT and to correlate the overall anatomic tumor response (CR, PR, SD, or PD) by RECIST criteria as assessed by CT and clinical examination obtained at baseline and after eight weeks of treatment with weekly scheduled doses of cetuximab to TTP (time to progression) and OS (overall survival) with cetuximab therapy.
* To determine the overall best anatomic tumor response rate (CR, PR, SD, or PD) to cetuximab given until disease progression as assessed by RECIST criteria using CT and clinical examination.
* To determine the overall disease control rate (CR, PR, and SD) by RECIST criteria as assessed by CT and clinical examination and to determine the TTP and the OS with cetuximab therapy.
* To assess the toxicity profile for standard of care cetuximab given to patients with metastatic squamous cell carcinoma of the head and neck.

Arms: arm 1: Whole body FDG-PET/CT scan and CT scan of neck and chest (within 28 days of Day 1)

Cetuximab 400 mg/m2 intravenously (IV) over 2 hours on day 1 and 250 mg/m2 IV over 1 hour on days 8, 15, 22, 29, 36, 43, and 50.

Whole Body FDG-PET/CT scan and CT scan of neck and chest on Day 57 (prior to cetuximab infusion)

Cetuximab 250 mg/m2 IV over 1 hour on Day 57

Cetuximab 250 mg/m2 IV over 1 hour weekly until progressive disease
Interventions: intervention 1: FDG-PET/CT intervention 2: Cetuximab
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00715793
Conditions: Malignant Melanoma
Keywords: Decitabine Temozolomide Metastatic Melanoma Non-resectable Stage IIIB melanoma stage IV melanoma TMZ DTIC promoter methylation skin cancer chemotherapy
Sponsor: Hussein Tawbi
Start date: 2008-06-01; Completion date: 2015-08-01
Enrollment: 39 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The combination of TMZ and DAC may effect dual modulation of DNA repair genes resulting in improved clinical response.

Detailed description:
Primary Objectives:

* Phase I: To determine the safety, tolerability, and Phase II recommended dose of the combination of extended schedule TMZ and DAC.
* Phase II: To determine the efficacy, as measured by overall response rate, of the combination of extended schedule TMZ and DAC given at the Phase II recommended dose to patients with metastatic melanoma.

Secondary Objectives:

* To determine pharmacokinetics of the combination of TMZ and DAC in patients with metastatic melanoma.
* To determine, in peripheral blood mononuclear cells (PBMC) and tumor tissue, the pharmacodynamic effects of the combination of TMZ and DAC on promoter methylation and expression of selected genes and correlate these with response.
* To determine the progression-free survival of patients treated with the combination of TMZ and DAC.

Arms: arm 1: None
Interventions: intervention 1: Decitabine intervention 2: Temozolomide intervention 3: biopsy
Intervention descriptions: intervention 1: In Part I patients will be treated on a standard "3+3" phase I dose-escalation design starting at 0.075 mg/kg until a decitabine dose level of 0.15 mg/kg is reached, or, in case unacceptable toxicities are observed, at the maximum tolerated dose (Phase II recommended dose). Decitabine will be administered at the specified dose level, intravenously, daily 5 days a week for the first 2 weeks of a 6-week cycle. intervention 2: Temozolomide is available in 25 mg and 100 mg tablets that will be administered orally; doses will be rounded to the nearest 25 mg. Temozolomide will be administered orally at 75 mg/m2 daily for 4 weeks starting on week 2 of a 6-week cycle. intervention 3: Fine needle aspirates (FNA) and/or core biopsies of tumor samples will be obtained from consenting patients with accessible, evaluable disease, on days 1, 8, 15, and 29 of the first cycle and when patients go off study. Biopsies are optional in Phase I and required for all consenting subjects in Phase II.

Protocol documents:
Clinical trial NCT00781898
Conditions: Opiate Addiction
Keywords: Depot naltrexone Parolees Opioid addiction prevention Medication Treatment Alternatives Prevention of Relapse to Opioid Addiction
Sponsor: University of Pennsylvania
Start date: 2008-06-01; Completion date: 2015-08-01
Enrollment: 308 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this project is to conduct a multi-site effectiveness study to determine whether the addition of a monthly injection of depot naltrexone to treatment as usual (TAU) will significantly improve outcome in parolees and probationers with a history of opioid addiction compared to TAU alone. Participants will be randomized to either treatment as usual in community programs or monthly injections of depot naltrexone for six months with treatment as usual in community programs. The effectiveness of depot naltrexone has never been studied in opioid dependent parolees. all parolee subjects will be evaluated at baseline, while in treatment, and at 6, 12 and 18 month post entry time points. The primary study outcomes are retention in treatment, drug use, re-arrests, psychosocial and medical/psychiatric functioning, and economic costs and benefit costs of naltrexone.

Detailed description:
This site serves as the coordinating center for five sites conducting the trial under the same IND and same protocol.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Depot naltrexone intervention 2: Treatment as Usual (TAU)
Intervention descriptions: intervention 1: Vivitrol® extended release naltrexone 380 mg per month delivered in monthly intramuscular injections. intervention 2: Treatment as Usual (TAU) community treatment provided to the participant

Protocol documents:
Clinical trial NCT00806676
Conditions: Chronic Kidney Disease
Keywords: chronic kidney disease children dialysis kidney transplant human papilloma virus Gardasil Chronic kidney disease (non-dialysis, dialysis, and kidney transplant) secondary to any cause.
Sponsor: Johns Hopkins University
Start date: 2008-12-01; Completion date: 2015-08-01
Enrollment: 67 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
People with chronic kidney disease are known to have immune response abnormalities, including a diminished response to some vaccinations. Those with chronic kidney disease have a disproportionate burden of HPV 6-, 11-, 16- and/or 18-related genital tract disease. Due to immune response abnormalities, the CKD population may or may not respond to the recommended three-dose regimen of Gardasil®, a vaccine intended to protect against HPV 6-, 11-, 16-, and 18-related genital tract disease. The objective of this study is to measure the antibody response to Gardasil® in female patients 9-21 years of age with chronic kidney disease (CKD) (Stage 1-4), end-stage kidney disease (Stage 5 CKD), and status-post kidney transplant. Gardasil® vaccine will be administered according to the FDA-approved schedule. Blood samples to measure antibody levels to vaccine strains of human papillomavirus (HPV) will be obtained at months 0, 7 and 24.

Detailed description:

Arms: arm 1: Gardasil vaccine series will be administered according to FDA-approved schedule, as recommended by the Centers for Disease Control and Prevention and the American Academy of Pediatrics. Geometric antibody titers among those with chronic kidney disease will be compared to titers in the general population measured during Phase III clinical studies by Merck \& Co, Inc, to prove efficacy of the vaccine and obtain FDA approval. arm 2: Gardasil vaccine series will be administered according to FDA-approved schedule, as recommended by the Centers for Disease Control and Prevention and the American Academy of Pediatrics. Geometric antibody titers among those with ESRD will be compared to titers in the general population measured during Phase III clinical studies by Merck \& Co, Inc, to prove efficacy of the vaccine and obtain FDA approval. arm 3: Gardasil vaccine series will be administered according to FDA-approved schedule, as recommended by the Centers for Disease Control and Prevention and the American Academy of Pediatrics. Geometric antibody titers among those with a kidney transplant will be compared to titers in the general population measured during Phase III clinical studies by Merck \& Co, Inc, to prove efficacy of the vaccine and obtain FDA approval.
Interventions: intervention 1: Gardasil® Vaccine (FDA-approved vaccination regimen)
Intervention descriptions: intervention 1: Standard Gardasil® 3-dose regimen (0.5 mL/dose; doses at 0, 2 and 6 months) delivered to females with chronic kidney disease 9-21 years of age.

Protocol documents:
Clinical trial NCT00824408
Conditions: Carcinoma, Non-Small-Cell Lung
Sponsor: Boehringer Ingelheim
Start date: 2009-03-01; Completion date: 2015-08-01
Enrollment: 143 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The trial objective will be to evaluate whether BI 6727 monotherapy or in combination with pemetrexed may be effective in the treatment of advanced or metastatic NSCLC in patients who relapsed after or failed first-line platinum based therapy.

The secondary objectives are to identify the acceptable dose of BI 6727 in combination with pemetrexed and to characterize the pharmacokinetic profiles of BI 6727 alone. Arm A, BI6727 monotherapy arm is closed to further recruitment.

Detailed description:

Arms: arm 1: BI 6727 plus 500 mg/\^m2 pemetrexed i.v. on day 1 of 21 day cycle arm 2: 500 mg/m\^2 i.v. on day 1 of a 21 day cycle
Interventions: intervention 1: pemetrexed intervention 2: pemetrexed intervention 3: BI 6727
Intervention descriptions: intervention 1: 500 mg/m\^2 i.v. on day 1 of 21 day cycle intervention 2: 500 mg/m\^2 i.v. on day 1 of 21 day cycle intervention 3: BI 6727 i.v. on day 1 of a 21 day cycle

Protocol documents:
Clinical trial NCT00861614
Conditions: Prostate Cancer
Sponsor: Bristol-Myers Squibb
Start date: 2009-05-01; Completion date: 2015-08-01
Enrollment: 988 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine if advanced prostate cancer patients that are treated with radiotherapy (RT) plus ipilimumab live longer that those treated with RT alone

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ipilimumab intervention 2: Placebo
Intervention descriptions: intervention 1: 5 mg/ml solution, Intravenous, 10 mg/kg, Every 3 weeks for up to 4 doses in the Induction Phase. Every 12 weeks in the Maintenance Phase, Up to 24 weeks in Induction, 48+ weeks in the Maintenance Phase, or until Treatment Stopping Criteria are met, withdrawal of consent, lost to follow-up, death, study closure intervention 2: Solution, Intravenous, 0 mg, Every 3 weeks for up to 4 doses in the Induction Phase. Every 12 weeks in the Maintenance Phase, up to 24 weeks in Induction, 48+ weeks in the Maintenance Phase, or until Treatment Stopping Criteria are met, withdrawal of consent, lost to follow-up, death, study closure

Protocol documents:
Clinical trial NCT00874497
Conditions: Chronic Obstructive Pulmonary Disease
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2009-03-01; Completion date: 2015-08-01
Enrollment: 84 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Phase 2a multicenter, randomized, double-blind, placebo-controlled study to assess the pharmacodynamics, efficacy, and safety of tetomilast in patients with emphysema.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: tetomilast intervention 2: placebo
Intervention descriptions: intervention 1: Oral tetomilast 25 mg once daily for 2 weeks followed by 50 mg once daily for 2 years. intervention 2: Placebo for 104 weeks (2 years)

Protocol documents:
Clinical trial NCT00874848
Conditions: NSCLC
Keywords: Imprime PGG NSCLC Cetuximab
Sponsor: HiberCell, Inc.
Start date: 2009-08-01; Completion date: 2015-08-01
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The Phase 2 study described in this protocol will serve to evaluate the antitumor activity, safety and pharmacokinetic profile of Imprime PGG when combined with cetuximab and concomitant paclitaxel and carboplatin therapy in patients with previously untreated advanced NSCLC. Additionally, this study will provide guidance for the design of more definitive efficacy studies of Imprime PGG in NSCLC patients.

Detailed description:

Arms: arm 1: Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin arm 2: Cetuximab + Paclitaxel/Carboplatin
Interventions: intervention 1: Imprime PGG Injection intervention 2: Cetuximab intervention 3: Paclitaxel intervention 4: Carboplatin
Intervention descriptions: intervention 1: 4 mg/kg i.v. over 2 hrs, weekly, in three week cycles intervention 2: initial loading dose of 400 mg/m\^2 over 120 min and subsequent doses at 250 mg/m\^2 over 60 min, weekly on Days 1, 8 and 15 of each 3-week treatment cycle intervention 3: 200 mg/m\^2 i.v. over 3 hr on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles intervention 4: dose equal to an AUC of 6 mg/mL · min based on the Calvert formula; i.v. over 30 min on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles

Protocol documents:
Clinical trial NCT00895661
Conditions: B-cell Lymphoma Indolent B-cell Lymphoma
Keywords: rituximab
Sponsor: Massachusetts General Hospital
Start date: 2009-07-01; Completion date: 2015-08-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this clinical trial is to see if increased doses of rituximab are safe and effective for the initial treatment of indolent B-cell lymphomas. Rituximab (Rituxan) is a type of drug called an "antibody" that specifically targets B-cell lymphoma cells, and is approved by the FDA for the treatment of indolent B-cell non-hodgkin lymphomas and certain other types of non-hodgkin lymphomas. Standard doses currently used may not be achieving maximal efficacy. Higher doses have been shown to be safe in other clinical trials, and may offer superior efficacy to the current standard dose. This trial also employs intermittent maintenance doses of rituximab at the standard dose, which has been shown to prolong remissions and survival in patients with relapsed indolent B-cell lymphomas. This trial is designed to show that higher dose rituximab plus maintenance rituximab can achieve similarly good results to chemotherapy approaches, but without chemotherapy-related toxicity.

Detailed description:
* All participants will receive increased-dose rituximab through a vein in the arm once a week for 4 weeks (on Days 1, 8, 15, and 22 of the initial 28-day study cycle). This first cycle of study treatment is called the Induction Phase. If the participant responds well to the Induction Phase, they then may continue to the Maintenance Therapy Phase, where they will receive a lower dose of rituximab once every three months for up to 2 years.
* During the Induction Phase, the following procedures will take place before the participant receives each dose of rituximab: medical review, physical exam, performance status, and ECG. Blood tests will be drawn about 30-60 minutes after the first dose of rituximab on Day 1. Samples will be drawn immediately before each dose and again 30-60 minutes after each dose on Days 1, 8, 15 and 22.
* During the Maintenance Therapy Phase, the following procedures will take place before the participant receives each dose of rituximab: medical review, physical exam, performance status, ECG, blood tests and response assessments by CT scan.

Arms: arm 1: single-arm, open-label, interventional
Interventions: intervention 1: rituximab
Intervention descriptions: intervention 1: Increased dose (750 mg/m2) intravenously for 4 weekly doses followed by maintenance dosing once every three months for up to 2 years. Maintenance dose is standard (375 mg/m2).

Protocol documents: