ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00475670
Conditions: Breast Cancer
Sponsor: Hoffmann-La Roche
Start date: 2005-10-01; Completion date: 2012-06-01
Enrollment: 44 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2 arm study will assess the efficacy and safety of intravenous Herceptin with or without a taxane for the first line treatment of metastatic breast cancer in women who have relapsed at least 12 months after a minimum of 10 months of (neo)adjuvant treatment with Herceptin for HER2-positive early breast cancer.Patients will receive either Herceptin monotherapy (loading dose of 4mg/kg iv, followed by weekly doses of 2mg/kg iv, or 8mg/kg loading dose followed by 3-weekly doses of 6mg/kg)or Herceptin + a taxane (docetaxel 100mg/m2 iv every 3 weeks, or paclitaxel 175mg/m2 iv every 3 weeks or 75mg/m2 every week). The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.

Detailed description:

Arms: arm 1: Participants received an initial loading dose of 4 milligrams per kilogram (mg/kg) trastuzumab intravenous (i.v.) on Day 1, followed by 2mg/kg i.v. weekly, or an initial loading dose of 8 mg/kg i.v. loading dose on Day 1, followed by 6 mg/kg i.v. every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. arm 2: Participant received an initial loading dose of 4 mg/kg trastuzumab i.v. on Day 1, followed by 2mg/kg i.v. weekly, or an initial loading dose of 8 mg/kg i.v. loading dose, followed by 6 mg/kg i.v. every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death; and concomitant taxane, which is either 100 milligrams per square meter (mg/m2) docetaxel i.v. every 3 weeks, or 75 mg/m2 weekly or 175 mg/m2 every 3 weeks paclitaxel for at least 18 weeks, or more at the discretion of the investigator.
Interventions: intervention 1: Trastuzumab intervention 2: Taxane (docetaxel or paclitaxel)
Intervention descriptions: intervention 1: 4 mg/kg i.v. loading dose on Day 1, followed by 2 mg/kg i.v. weekly; or 8 mg/kg i.v. loading dose, followed by 6 mg/kg i.v. every 3 weeks until disease progression, unacceptable toxicity, withdrawal or death. intervention 2: Docetaxel 100 mg/m2 i.v. every 3 weeks, or paclitaxel administered in a dose of 75 mg/m2 i.v. weekly or 175 mg/m2 i.v. every 3 weeks for at least 18 weeks, or more at the discretion of the investigator. Choice of taxane at the discretion of the investigator. Taxane may be administered at the same time, or 24 hours after, administration of trastuzumab.

Protocol documents:
Clinical trial NCT00489086
Conditions: Neoplastic Syndrome
Keywords: nevoid basal cell carcinoma syndrome basal cell carcinoma of the skin
Sponsor: UCSF Benioff Children's Hospital Oakland
Start date: 2004-07-01; Completion date: 2012-06-01
Enrollment: 36 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as tazarotene, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying topical tazarotene to see how well it works in treating patients with basal cell skin cancer and basal cell nevus syndrome on the face.

Detailed description:
OBJECTIVES:

* Determine whether topical tazarotene, administered over a period of 18 months as a chemopreventive agent, reduces the incidence of basal cell carcinomas (BCCs) on treated skin in patients with basal cell nevus syndrome (BCNS).
* Expand and refine chemopreventive strategies in patients with BCNS who are at high risk for the development of BCCs.

OUTLINE: This is an open-label, multicenter study.

Patients apply topical tazarotene cream to the face once daily for 18 months in the absence of unacceptable toxicity.

Arms: arm 1: Open label
Interventions: intervention 1: tazarotene
Intervention descriptions: intervention 1: Tazarotene is a member of the acetylenic class of retinoids.

Protocol documents:
Clinical trial NCT00521053
Conditions: Melanoma
Keywords: immune vaccine systemic Metastatic Melanoma (AJCC Stage III or IV)
Sponsor: Provectus Pharmaceuticals
Start date: 2007-09-01; Completion date: 2012-06-01
Enrollment: 80 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to investigate the effectiveness of intralesional (IL) PV-10 for locoregional treatment of metastatic melanoma. This study will also include assessment of response in untreated bystander lesions following intralesional injection of PV-10 into targeted lesions. Additional objectives are to determine the safety profile of PV-10 following intralesional injection, and assess the pharmacokinetic profile of PV-10 in the bloodstream following intralesional injection.

Detailed description:
This is a multicenter, open-label, single-agent study. Subjects with at least one melanoma lesion ≥ 0.2 cm in diameter that can be accurately measured by ruler/caliper or ultrasound will receive intralesional injection of PV-10 into each of up to twenty (20) Study Lesions. Additionally, one to two measurable Bystander Lesions may remain untreated and will be followed for assessment of bystander response.

To accurately reflect anticipated clinical use, repeat dosing of treated lesions will be allowed at the Investigator's discretion at weeks 8, 12 and 16 following initial treatment for those lesions not exhibiting complete response. Subjects will be followed for 52 weeks following initial treatment with PV-10.

Arms: arm 1: None
Interventions: intervention 1: PV-10 (10% rose bengal disodium)
Intervention descriptions: intervention 1: Intralesional injection for chemoablation

Protocol documents:
Clinical trial NCT00524225
Conditions: Von Willebrand Disease
Keywords: IL-11 von Willebrand disease von Willebrand factor VWFmRNA surgery
Sponsor: Margaret Ragni
Start date: 2008-02-01; Completion date: 2012-06-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the efficacy and safety of rhIL-11 when given subcutaneously in adults with type 1 von Willebrand disease undergoing elective surgery or major dental procedure. Efficacy will be measured by estimated blood loss, and frequency and severity of bleeding and transfusion requirement during and after surgery. Safety will be measured by the frequency of adverse events, including fever, headache, fatigue, myalgias, arthralgias, fluid retention, or edema.

Detailed description:
This study is a prospective, single-center Phase II trial of Neumega (rhIL-11) in adults with type 1 VWD undergoing elective surgery or major dental procedure. It is anticipated that 10 subjects who meet eligibility criteria will enroll and complete the study. The specific objectives are to determine the efficacy and safety or rhIL-11 during and after elective surgery, and to determine the mechanism of the hemostatic response of rhIL-11.

Arms: arm 1: Neumega (Oprelvekin, Interleukin 11, IL-11) 25 mcg/kg subcutaneously, given for 4 days preoperatively, and on day 5 preoperatively, and for up to 2 days postoperatively
Interventions: intervention 1: Neumega (Oprelvekin, Interleukin 11, IL-11)
Intervention descriptions: intervention 1: 25 micrograms/kg by subcutaneous injection once daily for four days, followed by once daily on days 1-3 before and after elective surgery or dental procedure

Protocol documents:
Clinical trial NCT00540722
Conditions: Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma Recurrent Adult Brain Tumor
Sponsor: National Cancer Institute (NCI)
Start date: 2008-01-01; Completion date: 2012-06-01
Enrollment: 56 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well gossypol works in treating patients with progressive or recurrent glioblastoma multiforme. Gossypol may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. To estimate the overall survival rate associated with AT-101 in treating adult patients with recurrent glioblastoma multiforme.

SECONDARY OBJECTIVES:

I. To assess and estimate the acute and late toxicities. II. Tumor response rate. III. To estimate 6-month progression free survival. IV. To explore associations of the clinical outcome (overall survival) among the changes of potential serum biomarkers, baseline tumor protein expression and gene methylation status.

OUTLINE: This is a multicenter study.

Patients receive oral R-(-)-gossypol once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Patients undergo tumor tissue and blood sample collection at baseline and periodically during study for biomarker correlative studies. Archived tumor tissue samples, if available, are analyzed for Bcl-2 family protein expression (e.g., Bcl-2, Bcl-xL, MCl-1, Bax, Bak, and BH3 domain for BH3 members only) and 06-methylguanine-DNA-methyltransferase (MGMT) gene methylation status. Blood samples are analyzed for apoptotic protein levels (Bcl-2) by enzyme-linked immunosorbent assay.

After completion of study therapy, patients are followed every 2 months.

Arms: arm 1: Patients receive oral R-(-)-gossypol once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Patients undergo tumor tissue and blood sample collection at baseline and periodically during study for biomarker correlative studies. Archived tumor tissue samples, if available, are analyzed for Bcl-2 family protein expression (e.g., Bcl-2, Bcl-xL, MCl-1, Bax, Bak, and BH3 domain for BH3 members only) and MGMT gene methylation status. Blood samples are analyzed for apoptotic protein levels (Bcl-2) by enzyme-linked immunosorbent assay.
Interventions: intervention 1: R-(-)-gossypol acetic acid intervention 2: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given PO intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT00549393
Conditions: Nosocomial Infections
Keywords: intensive care unit Healthcare associated infections (HAI) pediatric
Sponsor: Johns Hopkins University
Start date: 2008-02-01; Completion date: 2012-06-01
Enrollment: 5659 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The investigators propose to conduct a large clinical study to determine if daily bathing with chlorhexidine impregnated cloths will reduce the incidence of healthcare-associated infections in the Pediatric Intensive Care Unit (PICU).

Detailed description:

Arms: arm 1: Daily bathing with 2% chlorhexidine gluconate arm 2: Standard bathing with soap and water basin or disposable cloth
Interventions: intervention 1: 2% Chlorhexidine gluconate cloth
Intervention descriptions: intervention 1: Daily bathing

Protocol documents:
Clinical trial NCT00556322
Conditions: Non-Small Cell Lung Cancer
Sponsor: Hoffmann-La Roche
Start date: 2006-03-01; Completion date: 2012-06-01
Enrollment: 424 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2 arm study will evaluate the efficacy, safety, and pharmacokinetics of Tarceva and that of standard of care chemotherapy in patients with advanced, recurrent, or metastatic NSCLC experiencing disease progression after failure of platinum-based chemotherapy.Eligible patients will be randomized to receive either Tarceva 150mg po daily, or comparator (either Alimta 500mg/m2 every 3 weeks, or Taxotere 75mg/m2 every 3 weeks). The anticipated time on study treatment is until disease progression ,and the target sample size is 500+ individuals.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Alimta or Taxotere intervention 2: erlotinib [Tarceva]
Intervention descriptions: intervention 1: 500mg/m2 / 3 weeks (Alimta) or 75mg/m2 / 3 weeks (Taxotere) intervention 2: 150mg po daily

Protocol documents:
Clinical trial NCT00564889
Conditions: Multiple Myeloma and Plasma Cell Neoplasm
Keywords: primary systemic amyloidosis
Sponsor: Mayo Clinic
Start date: 2007-12-01; Completion date: 2012-06-01
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop plasma cells from growing. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of plasma cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with cyclophosphamide and dexamethasone may be an effective treatment for primary systemic amyloidosis.

PURPOSE: This phase II trial is studying how well giving lenalidomide together with cyclophosphamide and dexamethasone works in treating patients with primary systemic amyloidosis.

Detailed description:
OBJECTIVES:

Primary

\* Assess the hematologic response rate in patients with primary systemic amyloidosis treated with lenalidomide, cyclophosphamide, and dexamethasone.

Secondary

* Determine the organ response rate in patients treated with this regimen.
* Determine the toxicity of this regimen in these patients.
* Determine the time to progression in patients treated with this regimen.
* Determine the survival of patients treated with this regimen.

OUTLINE: Patients receive oral lenalidomide on days 1-21, oral cyclophosphamide\* on days 1, 8, and 15, and oral dexamethasone on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

NOTE: \*Patients may receive cyclophosphamide for up to 1 year. After completion of study treatment, patients are followed every 6 months for up to 3 years.

Arms: arm 1: Lenalidomide 15mg daily (days 1-21)

Cyclophosphamide 300 mg/m\^2 (days 1, 8, 15)

Dexamethasone 40 mg weekly
Interventions: intervention 1: cyclophosphamide intervention 2: dexamethasone intervention 3: lenalidomide
Intervention descriptions: intervention 1: 300 mg/m\^2 days 1, 8 \& 15 of a 28 day cycle taken orally with food intervention 2: 40 mg weekly taken orally intervention 3: 15 mg daily days 1-21 of a 28 day cycle taken orally with food

Protocol documents:
Clinical trial NCT00578071
Conditions: Cancer of the Esophagus
Keywords: esophageal cancer
Sponsor: Brian Czito
Start date: 2007-12-01; Completion date: 2012-06-01
Enrollment: 29 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary purpose of this trial is to define the maximum tolerated and/or recommended phase II dose of the combination of panitumumab, oxaliplatin and capecitabine in patients undergoing radiation therapy for carcinoma of the thoracic esophagus or gastroesophageal junction. An additional primary objective is to describe the frequency and nature of grade III/IV and grade I/II toxicities associated with this regimen. Secondary objectives include describing 1-year disease-free survival and overall survival rates as well as to estimate clinical and pathologic complete response rates associated with this regimen.

Detailed description:
This study has a phase I/II design. For this study the administration of panitumumab is considered investigational.

Pretreatment: Part of regular cancer care and disease staging includes Chest/Abdomen CT Scan, upper endoscopic ultrasound, PET scan, J-Tube Placement (if clinically indicated), bronchoscopy (per clinician judgment), ECG, and baseline laboratory studies.

During Treatment Weeks 1-5.5 of Radiation Therapy(RT)/Chemotherapy:

* RT (180 cGy/fx, Mon-Fri) days 1-5, 8-12, 15-19, 22-26, 29-33 and 36-38.
* Panitumumab (per dose level) days 1, 15, 29.
* Oxaliplatin (per dose level) days 1, 8, 15, 22, 29, 36.
* Capecitabine (per dose level M-F) 1-5, 8-12, 15-19, 22-26, 29-33, 36-38.

Arms: arm 1: panitumumab, oxaliplatin, capecitabine and EBRT
Interventions: intervention 1: Panitumumab intervention 2: Capecitabine intervention 3: Oxaliplatin intervention 4: Radiation Therapy (RT)
Intervention descriptions: intervention 1: Dose per cohort level (3.6, 4.8 or 6.0 mg/kg ), given intravenously (IV) days 1, 15 and 29 of radiation. intervention 2: Dose per cohort level (500, 625 or 825 mg/m2) taken by mouth twice each day of radiation intervention 3: Dose per cohort level (30, 40, or 50 mg/m2). Given IV one day each week during radiation intervention 4: Daily for 6 weeks

Protocol documents:
Clinical trial NCT00583700
Conditions: Fibrosis
Keywords: Breast Neoplasms Radiotherapy
Sponsor: University of Iowa
Start date: 2003-02-01; Completion date: 2012-06-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study seeks to determine if a combination of Trental and Vitamin E prevents the development of radiation fibrosis in women treated with radiation for the definitive management of their breast cancer.

Detailed description:
Radiation fibrosis occurs in approximately 25% of those women treated with radiation for breast cancer. Of these, approximately 3 to 5% will develop into an acute, painful form of fibrosis. Mild fibrosis can present as a thicker or more dense breast where the acute form can cause pain in the breast, significant hardening, and inflammation.

Treatments for fibrosis are lacking, with the primary treatment being hyperbaric oxygen therapy. The combination of Trental \& Vitamin E has been used with success in Europe and at the University of Iowa.

The focus of this study is to prevent fibrosis through intervention with Trental \& Vitamin E. The study has two arms, a control arm and an intervention arm. The study is not blinded. Measurements are taken at standard follow-up visits to measure breast density and lymphedema.

Arms: arm 1: Control for study - watchful waiting. arm 2: Combined treatment with Pentoxifylline and Vitamin E.
Interventions: intervention 1: Pentoxifylline intervention 2: Vitamin E
Intervention descriptions: intervention 1: Pentoxifylline 400 mg, 3 times daily for 7 months, beginning immediately after radiation therapy. intervention 2: Vitamin E (Over-the-counter) 400 I.U. once daily

Protocol documents:
Clinical trial NCT00601796
Conditions: Lung Cancer
Keywords: adenocarcinoma of the lung stage IV non-small cell lung cancer
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Start date: 2006-10-01; Completion date: 2012-06-01
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to find out what effects (good and/or bad) a tumor vaccine used in combination with two drugs (ATRA and cytoxan) have on the patient and their cancer. We also want to find out if the vaccine and the drugs can boost the patient's immune system and how their immune system reacts, both before and after the vaccine treatment.

Detailed description:
This protocol describes a phase II study involving patients with stage IV adenocarcinoma of the lung. Treatment will consist of Cyclophosphamide (300 mg/m²) to be given IV on day 1 and day 57. On day 4 immunization with intradermal vaccine injections at 4 separate sites (bilateral upper arms and bilateral upper thighs will be repeated every 14 days times 2 followed by every 28 days times 3 (day 4, 18, 32, 60, 88, and 116). Decavac (tetanus shot) 0.5 cc intramuscular (IM) will be given after the first vaccine. ATRA (150 mg/m2/day) oral three times daily (TID) dosing administered after the first and fourth vaccines (day 5-7 \& day 61-63). Those patients achieving stable disease (SD), partial response (PR), or complete response (CR) at restaging after the initial 6 vaccines will receive additional vaccines every 3 months until disease progression. The vaccine will consist of GM.CD40L bystander cells admixed with an equivalent number of the 2 allogeneic tumor cell lines. There will be a +/- 7 day window for all study related exams, tests, and procedures.

Arms: arm 1: Vaccine + Cytoxan + ATRA as outlined in Detailed Description
Interventions: intervention 1: Vaccine Treatment intervention 2: Cyclophosphamide intervention 3: All-trans retinoic acid (ATRA)
Intervention descriptions: intervention 1: We created a vaccine in which irradiated allogeneic lung adenocarcinoma cells are combined with a bystander K562 cell line transfected with hCD40L and hGM-CSF. By recruiting and activating dendritic cells, we hypothesized the vaccine would induce tumor regression in metastatic lung adenocarcinoma. Intradermal vaccine was given every 14 days x3, followed by monthly x3. intervention 2: Cyclophosphamide (300 mg/m\^2 IV) was administered before 1st and 4th vaccines to deplete regulatory T-cells. intervention 3: All-trans retinoic acid was given (150/mg/m\^2/day) after 1st and 4th vaccines to enhance dendritic differentiation.

Protocol documents:
Clinical trial NCT00615927
Conditions: Glioblastoma Gliosarcoma
Keywords: Glioblastoma Gliosarcoma glioblastoma multiforme (GBM) GBM Imatinib Mesylate Gleevec Hydroxyurea Droxia Hydrea Hydroxycarbamide Imatinib Brain tumor Malignant brain tumor Recurrent glioblastoma multiforme Progressive glioblastoma multiforme
Sponsor: Duke University
Start date: 2006-02-01; Completion date: 2012-06-01
Enrollment: 64 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Primary objective:

* To evaluate activity of imatinib mesylate and hydroxyurea among patients with progressive/recurrent grade II low-grade glioma (LGG) as measured by 12-month progression free survival

Secondary objectives:

* To evaluate progression-free survival (PFS), overall survival and objective response rate among patients with progressive/recurrent grade II LGG treated with imatinib mesylate plus hydroxyurea
* To assess safety and tolerability of imatinib mesylate + hydroxyurea in this population

Detailed description:
This is an open-label, single stage, uncontrolled, non-randomized Phase II study of continuous, daily doses of imatinib mesylate \& hydroxyurea in adult patients with progressive/recurrent Grade II low-grade glioma (LGG). The treatment cycle is defined as imatinib mesylate \& hydroxyurea administered daily for 28 days for purpose of scheduling evaluations. All patients who receive 1 or more doses of either imatinib mesylate or hydroxyurea will be evaluable for toxicity, whereas all patients who receive a minimum of 14 consecutive days of study regimen will be evaluable for response. Patients who discontinue therapy prior to receiving 14 consecutive days of study regimen will be regarded as ineligible for evaluation of response and will be replaced.

Arms: arm 1: Grade II Astrocytoma arm 2: Grade II Oligodendroglioma or oligoastrocytomas
Interventions: intervention 1: Imatinib Mesylate & Hydroxyurea
Intervention descriptions: intervention 1: Imatinib administered orally on daily. Imatinib is local irritant \& must be taken in sitting position; mini of 2hrs should be allowed between last drug intake \& going to bed. Imatinib doses 400mg/600mg administered once daily, whereas daily doses of 800mg/\> administered as equally divided dose taken twice day. Dose for imatinib: Pts not receiving p450-inducing antiepileptic drugs: 400 mg/day. Pts receiving p450-inducing antiepileptic drugs: 500 mg twice day. It is recommended that pts take their prescribed imatinib mesylate at same time that they take their prescribed hydroxyurea, however, 30-60min interval between agents is acceptable if required for practical/other compliance issues.

Hydroxyurea administered orally twice day. Dosing will begin on day 1 of cycle 1 \& continue daily. Drug is approximately 80 percent bioavailable. Dose will be 500mg twice day for all pts.

Protocol documents: