ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00788775
Conditions: Mucosal Lentiginous Melanoma Acral Melanoma Melanoma
Keywords: nilotinib
Sponsor: Dana-Farber Cancer Institute
Start date: 2009-01-23; Completion date: 2014-03-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Given the poor prognosis and limited treatment options available for patients with mucosal or acral/lentiginous melanomas who develop metastatic disease, genetic discoveries of KIT mutations in these cancers present the need to test multi-targeted kinase inhibitors with potent KIT inhibitory activity in this patient population. Imatinib and other tyrosine kinase inhibitors (TKIs) have the potential to be effective in this patient population, but patients may develop resistance to treatment. Therefore, in this study, we propose to test nilotinib in patients with metastatic mucosal, acral, or chronically sun-damaged melanoma following treatment with another TKI.

Detailed description:
OBJECTIVES:

Primary

\* To estimate the proportion of patients, with metastatic mucosal, acral, or chronically sun damaged melanomas, whose tumors have KIT aberrations, and who progressed or could not tolerate a KIT targeting tyrosine kinase inhibitor (TKI) (e.g. including but not limited to imatinib mesylate, sunitinib, or dasatanib), who are alive and without progression of disease four months after beginning treatment with nilotinib.

Secondary

* To determine early evidence of biologic and clinical activity by best overall response rate.
* To estimate time to progression of disease and overall survival.
* To determine the tolerability of nilotinib.
* To evaluate the use of FDG-PET scanning in determining early biologic response to therapy.
* To correlate c-kit mutational status and amplification status with response to therapy.
* To evaluate the feasibility of nilotinib.
* To evaluate the tolerability of nilotinib in patients with brain metastases.

Arms: arm 1: Nilotinib was given at a dose of 400 mg orally daily (200 mg pills twice per day). Patients received treatment up to 12 months as long as they were receiving clinical benefit.
Interventions: intervention 1: Nilotinib
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00799383
Conditions: Risperidone-induced Hyperprolactinemia
Keywords: Risperidone hyperprolactinemia children adolescents antipsychotics prevention calcium vitamin D Risperidone-induced hyperprolactinemia
Sponsor: Chadi A. Calarge
Start date: 2008-11-01; Completion date: 2014-03-01
Enrollment: 47 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether calcium and vitamin D supplementation, over a nine-month period, optimizes bone mineralization in boys with risperidone-induced hyperprolactinemia. We hypothesize that, by the end of the stuy, children in the supplementation group will have higher bone mineral density compared to those in the placebo group.

Detailed description:

Arms: arm 1: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period. arm 2: Placebo
Interventions: intervention 1: Calcium and Vitamin D intervention 2: Placebo
Intervention descriptions: intervention 1: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period. intervention 2: None

Protocol documents:
Clinical trial NCT00919061
Conditions: Extrahepatic Bile Duct Cancer Gallbladder Cancer
Keywords: GALL BLADDER BILE DUCTS BAY 43-9006 SORAFENIB CISPLATIN GEMCITABINE 09-029
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2009-08-01; Completion date: 2014-03-01
Enrollment: 39 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to test an investigational combination of drugs for bile duct or gallbladder cancers.

Gemcitabine and cisplatin are two forms of chemotherapy commonly used in combination to treat bile duct and gallbladder cancers. We are looking to improve treatment results. We will attempt to do so by adding sorafenib (a type of monoclonal antibody) to your treatment plan. Sorafenib acts by attaching to blocking specific targets on cells. These targets may help the cancer cells grow and divide. This study will help answer the question of whether sorafenib is a helpful drug in patients with bile duct or gallbladder cancers when given with gemcitabine and cisplatin.

This study is a phase 2 study. The purpose of a phase 2 study is to find out what effects, good and/or bad, sorafenib in combination with gemcitabine and cisplatin has on advanced bile duct and gallbladder cancers.

Detailed description:

Arms: arm 1: This is a non-randomized, open label, single institution, phase II study of gemcitabine and cisplatin plus sorafenib for the treatment of patients with advanced or biliary tract carcinomas naïve to systemic therapy.
Interventions: intervention 1: Gemcitabine intervention 2: Cisplatin intervention 3: Sorafenib
Intervention descriptions: intervention 1: Gemcitabine: 800 mg/m\^2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment. intervention 2: 20 mg /m\^2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment. intervention 3: 400 mg PO once a day continuously.

Protocol documents:
Clinical trial NCT00951379
Conditions: Oral Leukoplakia
Sponsor: National Cancer Institute (NCI)
Start date: 2010-02-01; Completion date: 2014-03-01
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of this clinical research study is to learn how Actos (pioglitazone) may affect oral premalignant lesions (OPLs) and/or the risk of mouth cancer. The safety of this drug will also be studied.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the clinical and histologic response of oral premalignant lesions to 24 weeks of therapy with pioglitazone, 45 mg once daily (qd), defined as 50% or greater reduction in the sum of all measured products of perpendicular dimensions of target lesions, or improvement in the degree of dysplasia or hyperplasia.

SECONDARY OBJECTIVES:

I. To determine the degree of change of putative biomarkers of pioglitazone efficacy including (but not restricted to) and in order of priority, tissue levels of:

* PPAR gamma,
* cyclin D1 and p21 as indirect measures of pharmacological effect
* TUNEL for apoptosis and Ki-67 for proliferation
* transglutaminase and involucrin as markers of squamous differentiation
* 15-PGDH, loss of heterozygosity (LOH). II. To determine the degree of change of C-reactive protein (CRP) in plasma. III. To assess tobacco and alcohol use among trial participants and to examine the relationship of tobacco and alcohol use to treatment response.

IV. To assess the safety of this agent in this population.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive pioglitazone hydrochloride orally (PO) once daily (QD) for 24 weeks.

ARM II: Patients receive placebo PO QD for 24 weeks.

After completion of study treatment, patients are followed up for 2 weeks.

Arms: arm 1: Three (3) Pioglitazone 15 mg capsules by mouth once daily for 24 weeks arm 2: Three (3) placebo capsules by mouth once daily for 24 weeks
Interventions: intervention 1: Pioglitazone hydrochloride intervention 2: placebo intervention 3: laboratory biomarker analysis
Intervention descriptions: intervention 1: Three (3) pioglitazone 15 mg capsules by mouth once daily for 24 weeks (+/- 1 week) intervention 2: Three (3) pioglitazone placebo capsules by mouth once daily for 24 weeks (+/- 1 week) intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT00982657
Conditions: Solid Tumor
Keywords: Phase Ib Phase II Advanced solid tumor Clear cell renal cancer Sunitinib plus / minus CVX-060
Sponsor: Pfizer
Start date: 2009-09-01; Completion date: 2014-03-01
Enrollment: 34 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The safety and tolerability of CVX-060 have been established in the first-in-human clinical trial, CVX-060-101. Thus, this phase Ib/II trial is to assess the safety and pharmacokinetics (PK) profiles of combining CVX-060 with sunitinib in patients with advanced solid tumors, and to subsequently assess the treatment efficacy of the combination treatment, as well as that of sunitinib alone in patients with advanced renal cell carcinoma (mRCC).

Detailed description:
On 23-Nov-2010, B1131001 (CVX-060-102) was closed to enrollment due to emerging clinical data which led to a re-assessment of the strategic goals of the PF-04856884 program. The study enrolled the Phase 1b portion only. Subsequently, on 25-Oct-2012, due to data safety signals in a separate clinical trial with PF-04856884 (CVX-060), all PF-04856884 studies were discontinued and ongoing patients on B1131001 were permitted to remain on study at a reduced PF-04856884 dose if determined to have been deriving clinical benefit.

Arms: arm 1: CVX-060 + sunitinib arm 2: CVX-060 + sunitinib arm 3: CVX-060 + sunitinib arm 4: CVX-060 + sunitinib arm 5: CVX-060 + sunitinib arm 6: sunitinib alone
Interventions: intervention 1: CVX-060 + sunitinib intervention 2: CVX-060 + sunitinib intervention 3: CVX-060 + sunitinib intervention 4: CVX-060 + sunitinib intervention 5: CVX-060 + sunitinib intervention 6: Sunitinib
Intervention descriptions: intervention 1: CVX-060 weekly infusions at 6.0 mg/kg + 50 mg sunitinib daily (4 out of 6 weeks) intervention 2: CVX-060 weekly infusions at 12.0 mg/kg + 50 mg sunitinib daily (4 out of 6 weeks) intervention 3: CVX-060 weekly infusions at 15.0 mg/kg + 50 mg sunitinib daily (4 out of 6 weeks) intervention 4: CVX-060 weekly infusions at TBD mg/kg + 50 mg sunitinib daily (4 out of 6 weeks) intervention 5: CVX-060 weekly infusions at TBD mg/kg + 50 mg sunitinib daily (4 out of 6 weeks) intervention 6: 50 mg sunitinib daily (4 out of 6 weeks)

Protocol documents:
Clinical trial NCT00993265
Conditions: Trichotillomania Hair Pulling
Keywords: Trichotillomania Hair pulling glutamate N-Acetylcysteine Children
Sponsor: Yale University
Start date: 2009-10-01; Completion date: 2014-03-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Trichotillomania (hair pulling) has an estimated lifetime prevalence of 1-3%. Children with trichotillomania can experience significant impairment due to peer teasing, avoidance of activities (such as swimming and socializing), difficulty concentrating on school work and medical complications due to pulling behaviors. Despite the fact that trichotillomania has a childhood onset, no randomized, controlled trials have been completed in childhood trichotillomania.

Research in adults with trichotillomania has demonstrated that most commonly currently prescribed treatment for trichotillomania, (pharmacotherapy with selective serotonin reuptake inhibitors) is ineffective in treating this condition. By contrast, randomized controlled trials in adults have suggested the efficacy of N-acetylcysteine as well as behavioral treatments such as Habit Reversal Therapy.

The goal of this trial is to determine the efficacy of N-Acetylcysteine for pediatric trichotillomania. N-Acetylcysteine is a glutamate modulating agent, with a fairly benign side-effect profile.

Detailed description:

Arms: arm 1: Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment. arm 2: Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.
Interventions: intervention 1: N-Acetylcysteine intervention 2: Placebo
Intervention descriptions: intervention 1: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks intervention 2: placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks

Protocol documents:
Clinical trial NCT01035658
Conditions: Ovarian Cancer Fallopian Tube Cancer Peritoneal Carcinoma
Keywords: Pazopanib Doxil Liposomal doxorubicin Advanced relapsed platinum-sensitive platinum-resistant
Sponsor: SCRI Development Innovations, LLC
Start date: 2010-01-01; Completion date: 2014-03-01
Enrollment: 22 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
In this study, patients with relapsed or refractory ovarian cancer will receive treatment with pazopanib and liposomal doxorubicin (Doxil) until disease progression or unacceptable toxicity occurs. The Phase I portion will define the dose limiting toxicity (DLT) of pazopanib and liposomal doxorubicin when administered in combination. Once the maximum tolerated dose has been identified in the Phase I portion, the Phase II portion will evaluate efficacy and safety of this combination in the same patient population.

Detailed description:
In this study, patients with relapsed or refractory ovarian cancer will receive treatment with pazopanib and liposomal doxorubicin (Doxil) until disease progression or unacceptable toxicity occurs. The Phase I portion will define the dose limiting toxicity (DLT) of pazopanib and liposomal doxorubicin when administered in combination. Once the maximum tolerated dose has been identified in the Phase I portion, the Phase II portion will evaluate efficacy and safety of this combination in the same patient population.

Arms: arm 1: Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (40mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal. arm 2: Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (30mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal. arm 3: Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (30mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal. arm 4: Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (40mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.
Interventions: intervention 1: Pazopanib intervention 2: Doxil
Intervention descriptions: intervention 1: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle. intervention 2: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle

Protocol documents:
Clinical trial NCT01048905
Conditions: Pulmonary Hypertension Sickle Cell Disease Thalassemia
Keywords: Pulmonary Hypertension Sickle Cell Disease Thalassemia
Sponsor: UCSF Benioff Children's Hospital Oakland
Start date: 2009-03-01; Completion date: 2014-03-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary hypothesis of this study is that glutamine supplementation will improve the erythrocyte glutamine/glutamate ratio, a biomarker of oxidative stress, hemolysis and pulmonary hypertension (PH) in sickle cell disease (SCD) and thalassemia (Thal) patients with PH. PH is defined as a tricuspid regurgitant jet velocity (TRV) on Doppler echocardiography \> 2.5 m/s. We also predict that glutamine therapy will increase arginine bioavailability and subsequently alter sickle red cell endothelial interaction that can be identified using endo-PAT technology through nitric oxide (NO) generation, leading to changes in biological markers, and clinical outcome. Specifically our second hypothesis is that oral glutamine will decrease biomarkers of hemolysis and adhesion molecules, and improve the imbalanced arginine-to-ornithine ratio that occurs in hemolytic anemias, leading to improved arginine bioavailability and clinical endpoints of endothelial dysfunction and PH in patients with SCD and Thal.

Detailed description:

Arms: arm 1: Patients will receive an 8-week course of oral L-glutamine 10 grams TID
Interventions: intervention 1: L-Glutamine
Intervention descriptions: intervention 1: Oral L-glutamine 10 grams TID or (0.1g/kg TID) for children \< 15 years of age.

Protocol documents:
Clinical trial NCT01055496
Conditions: Lymphoma, B-Cell
Keywords: Non-Hodgkin's lymphoma
Sponsor: Pfizer
Start date: 2010-03-01; Completion date: 2014-03-01
Enrollment: 103 participants; Allocation: NON_RANDOMIZED; Intervention model: 

Brief summary:
This is a phase 1 trial designed to evaluate safety and tolerability of chemotherapy in combination with inotuzumab ozogamicin, an investigational product, in adults with CD22-positive non-Hodgkin's lymphoma. The trial will involve two arms. In one arm, subjects will receive chemotherapy regimen R-CVP (rituximab, cyclophosphamide, vincristine and prednisone). In the other arm, subjects will receive R-GDP (rituximab, gemcitabine, cisplatinum and dexamethasone). Subjects in both arms will also receive inotuzumab ozogamicin.

Detailed description:

Arms: arm 1: Subjects in arm 1 will be enrolled in dose escalation cohorts that will initially evaluate an escalating dose of cyclophosphamide in combination with set doses of inotuzumab ozogamicin, vincristine, prednisone, and rituximab. arm 2: Subjects in arm 2 will be enrolled in dose escalation cohorts that will initially evaluate escalating doses of gemcitabine and/or cisplatinum in combination with set doses of inotuzumab ozogamicin, dexamethasone, and rituximab.
Interventions: intervention 1: inotuzumab ozogamicin+rituximab +cyclophosphamide+vincristine+prednisone intervention 2: inotuzumab ozogamicin+rituximab+gemcitabine+cisplatinum+dexamethasone
Intervention descriptions: intervention 1: Day 1:

Rituximab at 375 mg/m2 Cyclophosphamide at 375 mg/m2 (cohort 1), 550mg/m2 (cohort 2), 750 mg/m2 (cohort 3, 4) Vincristine at 1.4 mg/m2 (max 2 mg)

Day 2 Inotuzumab ozogamicin at 0.8 mg/m2 (cohort 1, 2, 3), 1.3 mg/m2 (cohort 4)

Days 1-5:

Prednisone at 40 mg/m2

Each cycle is 3 weeks, with a maximum of 6 cycles total. intervention 2: Day 1:

Rituximab at 375 mg/m2 Gemcitabine at 500 mg/m2 (cohort 1, 2b, 3b), 1000mg/m2 (cohort 2a, 3a, 4, 5) Cisplatin at 37.5 mg/m2 (cohort 1, 2a), 50mg/m2 (cohort 2b, 3a), 75mg/m2 (cohort 3b, 4, 5)

Day 2:

Inotuzumab ozogamicin at 0.8 mg/m2 (cohort 1, 2a, 2b, 3a, 3b, 4), 1.3mg/m2 (cohort 5)

Days 1-4:

Dexamethasone at 40 mg

Each cycle is 3 weeks, with a maximum of 6 cycles total.

Protocol documents:
Clinical trial NCT01078441
Conditions: Refractory Multiple Myeloma
Keywords: Bortezomib Liposomal Doxorubicin Dexamethasone Cyclophosphamide refractory multiple myeloma
Sponsor: National Cancer Institute (NCI)
Start date: 2010-09-01; Completion date: 2014-03-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well giving bortezomib together with liposomal doxorubicin hydrochloride, dexamethasone, and cyclophosphamide works in treating patients with multiple myeloma that relapsed after autologous stem cell transplant. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as liposomal doxorubicin hydrochloride, dexamethasone, and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with liposomal doxorubicin hydrochloride, dexamethasone, and cyclophosphamide may kill more cancer cells.

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate the 1-year survival of patients with relapsed multiple myeloma treated with bortezomib, liposomal doxorubicin, dexamethasone, and cyclophosphamide.

SECONDARY OBJECTIVES:

I. To evaluate response rates in patients treated with this regimen.

II. To evaluate the median time to progression in patients treated with this regimen.

III. To evaluate the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive bortezomib 1.3 mg/m2 subcutaneously on days 1, 8, and 15; liposomal doxorubicin 30 mg/m2 intravenously (IV) over 1 hour on day 4; oral dexamethasone 20mg on days 1, 2, 8, 9, 15 and 16; and cyclophosphamide 750 mg/m2 IV over 2 hours on day 1. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.

Peripheral blood and bone marrow samples may be collected for future research. Patients complete the Functional Assessment of Cancer Therapy (FACT) neurotoxicity questionnaire periodically.

After completion of study treatment, patients are followed up every 3 months for 3 years.

Arms: arm 1: Patients receive bortezomib 1.3 mg/m2 subcutaneously on days 1, 8, and 15; liposomal doxorubicin 30 mg/m2 intravenously (IV) over 1 hour on day 4; oral dexamethasone 20mg on days 1, 2, 8, 9, 15 and 16; and cyclophosphamide 750 mg/m2 IV over 2 hours on day 1. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: liposomal doxorubicin intervention 2: bortezomib intervention 3: dexamethasone intervention 4: cyclophosphamide
Intervention descriptions: intervention 1: Given IV intervention 2: Given subcutaneously. intervention 3: Given orally intervention 4: Given IV

Protocol documents: