ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00003458
Conditions: Childhood Brain Tumors
Keywords: Anaplastic astrocytoma Anaplastic glioma Anaplastic oligodendroglioma Astrocytoma Astrocytoma pilocytic Brain stem glioma Craniopharyngioma Ganglioglioma Glioblastoma multiforme Gliosarcoma Medulloepithelioma Neurocytoma Oligodendroglioma Oligodendroglioma-brainstem Primitive neuroectodermal tumor
Sponsor: Burzynski Research Institute
Start date: 1996-09-01; Completion date: 2014-09-01
Enrollment: 34 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Current therapies for childhood brain tumors provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of childhood brain tumors.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on children (\> 6 months of age) with brain tumors.

Detailed description:
OVERVIEW: This is a single arm, open-label study in which children with brain tumors receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of disease progression or unacceptable toxicity.

OBJECTIVES:

* To determine the efficacy of Antineoplaston therapy in children with a brain tumor, as measured by an objective response to therapy (complete response, partial response or stable disease).
* To determine the safety and tolerance of Antineoplaston therapy in children with a brain tumor.
* To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued to this study.

Arms: arm 1: Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Interventions: intervention 1: Antineoplaston therapy (Atengenal + Astugenal)
Intervention descriptions: intervention 1: Children with a brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal).

Protocol documents:
Clinical trial NCT00081939
Conditions: Multiple Myeloma
Sponsor: University of Arkansas
Start date: 2004-01-01; Completion date: 2014-09-01
Enrollment: 303 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
There have been two previous Total Therapy studies for multiple myeloma (MM) at the Myeloma Institute for Research and Therapy (MIRT): Total Therapy I (from 1989 through 1994) and Total Therapy II (from 1996 to 2004). Results have shown that patients treated on these studies had better outcomes (meaning patients have lived longer and had better responses to treatment) when compared to patients treated with standard chemotherapy.

With this new study, Total Therapy III, researchers will take what they have learned from the first two studies and add new treatment strategies to try to improve the outcomes even more, especially for patients with chromosome abnormalities.

Detailed description:
1.1 To determine, in a historical comparison with TT II (Thalidomide arm), whether two cycles of VDTPACE induction (instead of four induction cycles in TT II) followed by more timely MEL 200-based transplant with DEX + THAL between transplants can:

1.1.1 Increase the CR frequency from 50% to 60% at 18 months from initiation of therapy;

1.1.2 Increase \> n-CR rate pre-transplant #1 from 20% to 40%;

1.1.3 Raise 2-year EFS rates from 55% to 75% in patients with CA and from 80% to 95%, in patients without CA.

Arms: arm 1: Two cycles of VDTPACE induction (Velcade days 1, 4, 8, and 11; DTPACE days 4-7) with interim thalidomide (50 mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle. Induction followed by single or tandem MEL200 transplant (MEL140 mg/m2 for subjects \> 70 years of age) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each transplant. Transplants followed by two cycles of VDTPACE consolidation (Velcade days 1, 4, 8, and 11; DTPACE days 1-4) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle of VDTPACE. Consolidation followed by 3 years of maintenance therapy with VDT (velcade 1.0 mg/m2 days 1, 4, 8, 11 q 28 days; Thal 100 mg QD; and Dex 20mg days 1-4 and 8-11 q 28 days) during Year 1 and TD (Thal 100 mg QD and Dex 20 mg days 1-4, q 28 days) or VTD (velcade 1.0 mg/m2 weekly, Thal 100 mg QD, and Dex 20 mg weekly) during Years 2 and 3.
Interventions: intervention 1: Velcade intervention 2: Thalidomide
Intervention descriptions: intervention 1: Two cycles of induction on days 1,4,8,11 at 1.0mg/m\^2. Two cycles of consolidation on days 1,4,8,11 at 1.0mg/m\^2. Maintenance year one 1.0mg/m\^2 1,4,8,11 q 28 days. intervention 2: Two cycles of VDTPACE 200mg thal days 4-7(cycle 1)and days 1-4 cycle 2 interim Thal 50mg qd between VTDPACE cycles and between cycle 2 and transplant. Thal 100mg between transplants d/c 7 days prior to each transplant. Consolidation therapy cycles 3 and 4 VDTPACE 200mg days 1-4 both cycles. Interim maintenance to maintenance 100mg qd. Maintenance year 1 thal 100mg qd. Maintenance years 2 and 3 Thal 100mg qd.

Protocol documents:
Clinical trial NCT00118157
Conditions: Estrogen Receptor Positive Male Breast Carcinoma Progesterone Receptor Positive Recurrent Breast Carcinoma Stage IIIB Breast Cancer Stage IIIC Breast Cancer Stage IV Breast Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2005-05-01; Completion date: 2014-09-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well giving lapatinib ditosylate together with tamoxifen citrate works in treating patients with breast cancer that has spread from where it started to nearby tissue or lymph nodes or to other areas of the body and did not respond to previous treatment with tamoxifen citrate. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate may fight breast cancer by blocking the use of estrogen by the tumor cells. Sometimes when tamoxifen citrate is given, it does not stop the growth of tumor cells. The tumor is said to be resistant to tamoxifen citrate. Giving lapatinib ditosylate together with tamoxifen citrate may reduce drug resistance and allow the tumor cells to be killed.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the response rate (complete response and partial response) of tamoxifen (tamoxifen citrate) and GW572016 (lapatinib ditosylate) in women with hormone refractory, metastatic breast cancer.

II. To describe the changes in phosphorylation of epidermal growth factor receptor (EGFR), human EGFR 2 (her2), protein B kinase (AKT) kinase, mitogen activated protein kinase (MAPK), estrogen receptor (ER)-Serine (Ser) 118, and ER-Ser167 in tumor tissue after administration of tamoxifen and GW572016.

OUTLINE:

Patients receive lapatinib ditosylate orally (PO) daily and tamoxifen citrate PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 1 month and then every 3 months thereafter.

Arms: arm 1: Patients receive lapatinib ditosylate PO daily and tamoxifen citrate PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Laboratory Biomarker Analysis intervention 2: Lapatinib Ditosylate intervention 3: Tamoxifen Citrate
Intervention descriptions: intervention 1: Correlative studies intervention 2: Given PO intervention 3: Given PO

Protocol documents:
Clinical trial NCT00428220
Conditions: Metastatic Breast Cancer Advanced Breast Cancer Metastatic Castration Resistant Prostate Cancer Metastatic Renal Cell Cancer Non-Small Cell Lung Cancer Thyroid Cancer Advanced/Metastatic Non-Small Cell Lung Cancer Advanced Gastric Cancer Gastrointestinal Stromal Tumor Hepatocellular Carcinoma Pancreatic Islet Cell Carcinoma Pancreatic Neuroendocrine Tumor
Keywords: Potentially other tumor types in the future
Sponsor: Pfizer
Start date: 2007-07-01; Completion date: 2014-09-01
Enrollment: 223 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a study using sunitinib for patients ending treatment on a previous sunitinib malate protocol to continue to receive sunitinib. The patient must have been enrolled in one of the following studies: A6181030, A6181064, A6181078, A6181087, A6181094, A6181107, A6181108, A6181110, A6181111, A6181112, A6181113, A6181120, A6181126 and A6181170. Other Pfizer sponsored sunitinib studies may be included in the future.

Detailed description:

Arms: arm 1: Sunitinib will be administered in a continuous daily dose (oral, once per day). Starting dose will be 37.5 mg daily unless the patient was on a different dose (25 mg or 50 mg daily) on the previous trial. In that case, they will begin treatment on this study at the same dose used at the end of the previous study.

The protocol now allows for patients on dosing regimens other than only continuous dosing (e.g. 4/2, etc.) to be enrolled if eligible.
Interventions: intervention 1: sunitinib
Intervention descriptions: intervention 1: sunitinib

Protocol documents:
Clinical trial NCT00661583
Conditions: Glaucoma
Keywords: trabeculectomy glaucoma ranibizumab
Sponsor: University of Colorado, Denver
Start date: 2008-04-01; Completion date: 2014-09-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to study the safety of the combination of ranibizumab and MMC vs monotherapy MMC vs intravitreal ranibizumab injection in patients with glaucoma.

Detailed description:
A common problem after undergoing trabeculectomy surgery to create a bleb (blister or bubble) to reduce intraocular pressure, is scarring of the opening. This scarring prevents fluid drainage and interferes with the proper functioning of the bleb. MMC (Mitomycin C) is usually administered intraoperatively, to reduce scarring and increase filtration. However, the failure rate of trabeculectomy remains high. Anti-VEGF (Vascular endothelial growth factor) agents have been used successfully in cases requiring bleb needling. The purpose of the study is to determine the safety of the combination of ranibizumab and MMC vs monotherapy MMC in patients with glaucoma.

This is an open-label, Phase I/II safety study of 30 patients randomized to either treatment with ranibizumab 0.5 mg intravitreally injected (n=10), combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10) or MMC therapy alone (n=10).

For the ranibizumab groups, a repeat injection of ranibizumab 0.5mg may be given PRN (as needed) at 1 month if hypervascularity or neovascularization of the conjunctiva exists.

Arms: arm 1: Treatment with ranibizumab 0.5 mg intravitreally injected (n=10) arm 2: Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10) arm 3: MMC therapy alone (n=10)
Interventions: intervention 1: Ranibizumab intervention 2: Ranibizumab and MMC intervention 3: MMC
Intervention descriptions: intervention 1: 0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed intervention 2: Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy intervention 3: MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy.

Protocol documents:
Clinical trial NCT00726375
Conditions: Acute Graft Versus Host Disease
Keywords: (GVHD)
Sponsor: University of Michigan Rogel Cancer Center
Start date: 2008-05-01; Completion date: 2014-09-01
Enrollment: 34 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a clinical trial to see if treatment with etanercept for early skin graft-versus-host disease (GVHD) can effectively treat and prevent progression of the disease without using high dose steroids.

GVHD is a common complication following a bone marrow transplant from another donor. GVHD occurs after transplant, when the donor's blood cells (called lymphocytes) recognize parts of your body, such as the skin, as foreign. A certain chemical, called Tumor Necrosis Factor, or TNF, also causes damage to the skin. The main effect on the skin is a red rash, when the skin GVHD is mild, but in more severe forms the skin can blister.

We have been studying GVHD at the University of Michigan for the past decade. We know that high levels of TNF makes GVHD worse. Our research has shown that adding an anti-TNF drug (called etanercept or Enbrel®) to the standard GVHD treatment of high dose steroids leads to improvement in the GVHD in twice as many patients compared to when steroids alone are used. It is now standard practice at the University of Michigan and many other centers to treat GVHD with both steroids and etanercept.

The management of early skin GVHD for most patients involves treatment with steroids, given both as a cream and by either the mouth (in pills) or IV. Early skin GVHD is also called grade I GVHD, which means the skin rash covers less than half of the body. Steroid treatment can be effective; however, it also causes many complications such as an increased risk of infection, weight gain, stomach ulcers, muscle weakness and bone damage, among many others. We have developed this study to test whether starting treatment with etanercept and steroid creams alone can treat the GVHD without requiring the use of high dose steroids. The goal is to avoid the complications that come with high dose oral or IV steroid treatment. The high dose steroid treatment would only begin if your GVHD got worse.

Detailed description:

Arms: arm 1: a maximum of 8 SQ doses of 'Etanercept (Enbrel) at 0.4mg/kg per dose up to a maximum of 25 mg per dose
Interventions: intervention 1: Etanercept (Enbrel)
Intervention descriptions: intervention 1: Etanercept will begin within 72 hours of the diagnosis of Grade I acute GVHD and after consent for this study. Subjects receive eight doses of etanercept over four weeks. All doses will be administered by SQ injection. All subsequent doses will be given as subcutaneous injections into the skin. Injections will be given twice weekly with at least one day in between injections. The injections can be given in clinic, in the hospital, or self administered injections.

Protocol documents:
Clinical trial NCT00814671
Conditions: Tuberculosis
Keywords: Tuberculosis Pharmacokinetics
Sponsor: Johns Hopkins University
Start date: 2010-04-01; Completion date: 2014-09-01
Enrollment: 153 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of this Phase 2 study is to determine the microbiological activity and safety of rifapentine when given as a component of multidrug intensive phase treatment of smear-positive pulmonary tuberculosis (TB).

Funding Source- FDA Office of Orphan Products Development (OOPD)

Detailed description:
Prospective phase II, open-label, single center study in which each experimental rifapentine regimen is evaluated using a two-stage design. Adults (HIV-negative, or HIV-positive with CD4 \> 200 cells/cu mm) suspected to have pulmonary tuberculosis who meet eligibility criteria will be randomized to receive one of three intensive phase regimens. Intensive phase regimens will consist of once daily isoniazid, pyrazinamide, and ethambutol, plus one of the following: rifampin 600 mg once daily OR rifapentine 450 mg once daily OR rifapentine 600 mg once daily. Randomization will be stratified by presence/absence of cavitation on baseline chest radiograph. In Stage 1, 15 subjects will be randomized to each arm, following which there will be an enrollment pause for efficacy and safety assessment. Any rifapentine regimen for which fewer than 6 of 11 evaluable participants have week 8 culture conversion will be discarded.

Stage 2 will randomize subjects into the remaining "accepted arms" with a maximum of 36 additional subjects per arm.

All subjects will continue TB treatment with a conventional continuation phase treatment.

Study Site

Study subjects will be recruited from the University of Cape Town inpatient wards and outpatient clinics.

Estimated Study Duration

It is estimated that 18 months will be required for recruitment and enrollment of study subjects. The estimated duration of participation for each study subject is 18 months, including 2 months of experimental intensive phase TB treatment, 4 months of non-experimental conventional continuation phase TB treatment, and an additional 12 months for follow-up for TB relapse.

Study Management

Study subjects will have study visits on days 0, 7, 14, 21, 28, 35, 42, 49, and 56 for sputum collection and adverse event assessment. Safety laboratory monitoring will be performed on days 14, 28, 42, and 56 and will consist of complete blood count, serum alanine aminotransferase, serum total bilirubin, and serum creatinine. Steady state pharmacokinetic analysis will be performed on approximately day 28. Subjects will have additional study visits at week 10 and at months 4, 6, 12, and 18.

Arms: arm 1: Rifapentine 450mg daily arm 2: Rifampin 600mg daily arm 3: Rifapentine 600mg daily
Interventions: intervention 1: Rifapentine 450 intervention 2: Rifapentine 600 intervention 3: Rifampin
Intervention descriptions: intervention 1: rifapentine 450 mg intervention 2: rifapentine 600 mg intervention 3: rifampin 600 mg

Protocol documents:
Clinical trial NCT00866281
Conditions: Acute Myeloid Leukemia Acute Lymphoblastic Leukemia
Keywords: Acute Myeloid Leukemia AML Acute Lymphoblastic Leukemia ALL midostaurin PKC412 Pediatric relapsed or refractory FLT3 positive Acute Myeloid Leukemia Pediatric relapsed or refractory Mixed-lineage leukemia gene rearranged Acute Lymphoblastic leukemia
Sponsor: Novartis Pharmaceuticals
Start date: 2009-09-01; Completion date: 2014-09-01
Enrollment: 22 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase I/II pediatric dose-ranging study that will evaluate the safety, tolerability, clinical response, pharmacokinetics and pharmacodynamics of midostaurin in patients \<18 years of age who have relapsed or refractory acute leukemias that may benefit from administration of midostaurin, including MLL-rearranged ALL and FLT3 positive AML.

Detailed description:

Arms: arm 1: Participants received bodyweight and body surface area (BSA) stratified dose of midostaurin 30 mg/m\^2 twice daily (bid) through oral route. The total daily dose in 30 mg/m\^2 bid cohort was 60 mg/m\^2. arm 2: Participants received bodyweight and BSA stratified dose of midostaurin 60 mg/m\^2 bid through oral route. The total daily dose in 60 mg/m\^2 bid cohort was 120 mg/m\^2.
Interventions: intervention 1: midostaurin
Intervention descriptions: intervention 1: Midostaurin 25 mg/mL oral solution was provided in bottles of 50 mL, administered with water. The pediatric starting dose of midostaurin was set at 30 mg/m2 bid and was not to exceed 60 mg/m2 bid.

Protocol documents:
Clinical trial NCT00887575
Conditions: Breast Cancer
Keywords: Breast Cancer Triple-Negative Paclitaxel Carboplatin Sunitinib Sutent Neoadjuvant
Sponsor: SCRI Development Innovations, LLC
Start date: 2009-06-01; Completion date: 2014-09-01
Enrollment: 54 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This trial will examine the combination of sunitinib plus paclitaxel and carboplatin as neoadjuvant treatment for locally advanced breast cancer.

Detailed description:
This open label, Phase I/II trial is designed to evaluate the combination of sunitinib plus paclitaxel and carboplatin as neoadjuvant treatment for locally advanced breast cancer. The Phase I portion of this study will determine the maximum tolerated dose (MTD) of paclitaxel, sunitinib and carboplatin that can be used together as neoadjuvant treatment in patients with locally advanced breast cancer. The MTD identified in the Phase I portion of the study will be used in the Phase II portion which will evaluate the efficacy, safety, and tolerability of neoadjuvant sunitinib/paclitaxel/carboplatin given for 6 cycles in patients with locally advanced breast cancer.

Arms: arm 1: Neoadjuvant - Paclitaxel IV (70 mg/m\^2) days 1, 8 and 15 of each cycle, Carboplatin IV (AUC = 5) day 1 of every cycle and Sunitinib PO (25mg) daily.

Maintenance - Sunitinib PO (25mg) daily arm 2: Paclitaxel IV (80 mg/m\^2) days 1, 8 and 15 of each cycle, Carboplatin IV (AUC = 5) day 1 of every cycle and Sunitinib PO (25mg) daily. arm 3: Paclitaxel IV (80 mg/m\^2) days 1, 8 and 15 of each cycle, Carboplatin IV (AUC = 6) day 1 of every cycle and Sunitinib PO (25mg) daily.
Interventions: intervention 1: Paclitaxel intervention 2: Carboplatin intervention 3: Sunitinib
Intervention descriptions: intervention 1: IV infusion per institutional guidelines on Days 1, 8 and 15 of a 28 day cycle as follows depending on dose level (DL): DL1- 70 mg/m2, DL2- 80 mg/m2, DL3- 80mg/m2, DL4- 80mg/m2, DL-1- 70mg/m2, DL-2- 60mg/m2 intervention 2: IV infusion per institutional guidelines Day 1 of a 28 day cycle as follows depending on dose level (DL): DL1- AUC=5, DL2- AUC=5, DL3- AUC=6, DL4- AUC=6, DL-1- AUC=4, DL-2- AUC=4 intervention 3: By mouth (PO) once daily on days 1-21 of a 28 day cycle as follows depending on dose level (DL): DL1- 25mg, DL2-25mg, DL3- 25mg, DL4- 37.5mg, DL-1- 25mg, DL-2- 25mg. Maintenance therapy of 25mg daily

Protocol documents:
Clinical trial NCT00894504
Conditions: Metastatic Breast Cancer
Keywords: Metastatic Breast Cancer Triple Negative Panitumumab Vectibix Gemcitabine Gemzar Carboplatin
Sponsor: SCRI Development Innovations, LLC
Start date: 2010-02-01; Completion date: 2014-09-01
Enrollment: 71 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
In this Phase II trial, the investigators will evaluate the combination of gemcitabine, carboplatin, and panitumumab in the treatment of patients with metastatic triple-negative breast cancer. In addition, to assess the efficacy of this combination, tumor tissue will be examined for the presence of various markers, including K-ras and PI3K-activating mutations, EGFR, PTEN, and p53. Correlation of tumor response with marker expression may define a patient subset that is particularly responsive to treatment with a panitumumab-containing combination.

Detailed description:
All patients will receive a pre-emptive skin care regimen during panitumumab therapy to reduce skin toxicity. Treatment cycles will be repeated every 14 days (2 weeks). During each treatment, panitumumab will be administered first, then carboplatin, then gemcitabine. All drugs will be administered according to standard guidelines. Patients will be re-evaluated for response after completion of 3 cycles (6 weeks) of treatment. Patients with objective response or stable disease will continue treatment. Subsequent re-evaluations will occur every 6 weeks. Patients will continue treatment with all three drugs until tumor progression, or until unacceptable toxicity occurs. If patients experience toxicity caused by gemcitabine/carboplatin and are continuing to benefit from treatment, panitumumab can be continued as a single agent (at the same dose and schedule), at the discretion of the investigator, until disease progression occurs.

Arms: arm 1: Systemic therapy
Interventions: intervention 1: Panitumumab intervention 2: Carboplatin intervention 3: Gemcitabine
Intervention descriptions: intervention 1: 6 mg/kg IV on Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks) intervention 2: AUC=2.5 IV, Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks) intervention 3: 1500 mg/m2 IV, Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks)

Protocol documents: