ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00090870
Conditions: Kidney Cancer
Keywords: stage IV renal cell cancer
Sponsor: Medical University of South Carolina
Start date: 2002-04-01; Completion date: 2010-03-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining PEG-interferon alfa-2b with sargramostim and thalidomide may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving PEG-interferon alfa-2b together with sargramostim and thalidomide works in treating patients with metastatic kidney cancer.

Detailed description:
OBJECTIVES:

Primary

* Determine the response to PEG-interferon alfa-2b, sargramostim (GM-CSF), and thalidomide in patients with metastatic renal cell carcinoma.

Secondary

* Determine duration of response in patients treated with this regimen.
* Determine the tolerance to and toxicity of this regimen in these patients.
* Determine the median and progression-free survival of patients treated with this regimen.

OUTLINE: Patients receive PEG-interferon alfa-2b subcutaneously (SC) on days 1 and 8, sargramostim (GM-CSF) SC on days 1-10, and oral thalidomide once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

Arms: arm 1: None
Interventions: intervention 1: PEG-interferon alfa-2b intervention 2: GM-CSF intervention 3: thalidomide
Intervention descriptions: intervention 1: Peg-Intron 1ug/kg Subcutaneous on day 1 and day 8 of each cycle. Each cycle is 21 days. intervention 2: GM-CSF 250 ug/m2 subcutaneously daily from days 1-10 or each 21 day Peg-Intron cycle intervention 3: 200mg daily by mouth

Protocol documents:
Clinical trial NCT00104650
Conditions: Bone Metastases in Men With Hormone-Refractory Prostate Cancer Bone Metastases in Subjects With Advanced Breast Cancer Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma
Keywords: Bone Metastases AMG 162 Bisphosphonates Solid Tumor Carcinomas Advanced
Sponsor: Amgen
Start date: 2005-01-01; Completion date: 2010-03-01
Enrollment: 111 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to determine the effectiveness of AMG 162 in reducing urinary N-telopeptide in advanced cancer subjects with bone metastases.

Detailed description:

Arms: arm 1: This is an open-label randomization to receive IV bisphosphonate (administered per package insert) every 4 weeks during the treatment phase. If subjects are enrolled into the extension phase, they will receive AMG 162 180mg (SC) every 4 weeks. arm 2: This is an open-label randomization to receive 180 mg AMG 162 (SC) every 12 weeks during the treatment phase. If subjects are enrolled into the extension phase, they will continue to receive 180 mg AMG 162 (SC) every 12 weeks. arm 3: This is an open-label randomization to receive 180 mg AMG 162 (SC) every 4 weeks during the treatment phase. If subject is enrolled into the extension phase, they will continue to receive 180 mg AMG 162 (SC) every 4 weeks.
Interventions: intervention 1: AMG 162 180 mg (SC) q 12 weeks intervention 2: IV Bisphosphonate q 4 weeks intervention 3: AMG 162- 180 mg q 4 weeks
Intervention descriptions: intervention 1: A 180 mg AMG 162 (SC) administered every 12 weeks for 2 doses (Day 1 and wk 13) in the treatment phase. If subjected are enrolled in the extension phase, they will continue to receive a 180 mg AMG 162 (SC) administered every 12 weeks for 9 doses. intervention 2: IV Bisphosphonate (eg pamidronate or zoledronic acid) every 4 weeks for 6 doses as described by package insert during the treatment phase. If enrolled to the extension phase, subject will be assigned to the AMG 162 180mg (SC) every 4 weeks for 26 doses. intervention 3: A 180 mg AMG 162 (SC) administered every 4 weeks for 6 doses in the treatment phase. If subjected are enrolled in the extension phase, they will continue to receive a 180 mg AMG 162 (SC) administered every 4 weeks for 26 doses.

Protocol documents:
Clinical trial NCT00106028
Conditions: Osteogenesis Imperfecta
Keywords: Primary disease: Osteogenesis Imperfecta
Sponsor: Warner Chilcott
Start date: 2004-11-01; Completion date: 2010-03-01
Enrollment: 143 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Children with Osteogenesis Imperfecta (OI) have bone pain, low bone mass and fractures. There are no approved drugs for the treatment of OI in children, even though some intravenous (IV) bisphosphonates are used off-label in some countries. In a single dose, pharmacokinetic study, data showed that risedronate was well tolerated in 28 children with OI. This three year study will test the safety and efficacy of risedronate in the treatment of children with OI. For the first year, patients will be randomized to the risedronate and placebo groups in a 2:1 ratio. For the second and third years of the study, all patients will receive risedronate.

Detailed description:

Arms: arm 1: placebo tablet, once a day for one year then for two years open label risedronate arm 2: risedronate tablet, once a day for one year then for two years open label risedronate once a day
Interventions: intervention 1: risedronate sodium (Actonel) intervention 2: Placebo
Intervention descriptions: intervention 1: risedronate tablet once a day for one year followed by risedronate once a day for two years intervention 2: placebo tablet once a day for one year followed by risedronate once a day for two years

Protocol documents:
Clinical trial NCT00137436
Conditions: Prostatic Neoplasms
Keywords: First-line treatment of metastatic hormone-refractory prostate cancer SUTENT in combination with docetaxel and prednisone
Sponsor: Pfizer
Start date: 2005-10-01; Completion date: 2010-03-01
Enrollment: 93 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a multi-center, open-label, Phase 1/2 study of SU011248 (sunitinib malate, SUTENT) in combination with docetaxel and prednisone for the first-line treatment of metastatic hormone-refractory prostate cancer (mHRPC).

Detailed description:

Arms: arm 1: SU011248 in combination with docetaxel and prednisone
Interventions: intervention 1: Docetaxel intervention 2: Prednisone intervention 3: SU011248
Intervention descriptions: intervention 1: Docetaxel Phase 1 - escalating doses (60 and 75 mg/m2), intravenous therapy (IV), administered every 3 weeks. Phase 2 - Phase 1 optimal combination dose (75 mg/m2, IV, every 3 weeks). intervention 2: Prednisone Phase1/2 - 5 mg twice a day (BID), oral. intervention 3: SU011248 Phase 1 - escalating doses (12.5, 37.5, and 50 mg), oral, administered on a 2-weeks on, 1-week off daily regimen (Schedule 2/1). Phase 2 - Phase 1 optimal combination dose (37.5 mg/day, oral, Schedule 2/1).

Protocol documents:
Clinical trial NCT00138658
Conditions: Non-small Cell Lung Cancer
Keywords: NSCLC custirsen sodium OGX-011 Stage IIIB or IV advanced non-small cell lung cancer
Sponsor: Achieve Life Sciences
Start date: 2004-11-01; Completion date: 2010-03-01
Enrollment: 85 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This clinical study will help determine if giving OGX-011 (custirsen sodium) in combination with gemcitabine (GEM) and cisplatin (CIS) or carboplatin (CARB) is a safe and effective treatment for patients with lung cancer. This study will help to assess the safety and anti-tumor effect of OGX-011 when given to patients in combination with GEM and CIS/CARB.

Detailed description:
OGX-011 is an experimental drug that has been shown to increase the effectiveness of commonly used cancer therapies such as chemotherapy, radiation and hormone therapy in several kinds of cancer types in animals. OGX-011 is being studied in the treatment of cancer patients in combination with chemotherapy. In humans, OGX-011 in combination with hormone therapy has been shown to decrease the tissue levels of a protein called clusterin, which can be overproduced in cancer cells. Clusterin has been found to block cell death and makes cells more resistant to cancer therapy. Gemcitabine (GEM), cisplatin (CIS) and carboplatin (CARB) have been approved by Health Canada and the Food and Drug Administration in the United States for the treatment of patients with lung cancer.

OGX-011 was administered as a 2-hr intravenous (IV) infusion on Days -7, -5, and -3 prior to Cycle 1, then weekly on Days 1, 8, 15 of each 21-day cycle; GEM was infused IV after OGX-011 on Days 1 and 8; either CIS or CARB was infused IV after GEM on Day 1 of each cycle. Six cycles of treatment were planned. Most patients received OGX-011 at 640 mg, but 3 patients received OGX-011 at 480 mg dose; OGX-011 dose groups were combined due to the small number of patients who received 480 mg.

Interventions: intervention 1: custirsen sodium
Intervention descriptions: intervention 1: Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and 3 of Cycle 1 (pretreatment loading dose). OGX 011 was then to be infused for 2 hours weekly on Days 1, 8, and 15 of a 21-day cycle. Gemcitabine (GEM) was to be infused intravenously for 30 minutes on Days 1 and 8 and either cisplatin (CIS) or carboplatin (CARBO) were to be infused intravenously on Day 1 of this 21-day cycle. Patients were to receive a maximum of 6 cycles (1 cycle = 21 days)

Protocol documents:
Clinical trial NCT00145418
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Non small Cell Lung Cancer Stage IIIb and IV
Sponsor: Oncology Specialists, S.C.
Start date: 2005-02-01; Completion date: 2010-03-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
It has been accepted and proven that patients with unresectable lung cancer can benefit from systemic chemotherapy. Traditional platinum-based therapy has significant side effects. Oxaliplatin and docetaxel have both shown to be effective for lung cancer. The purpose of this study is to determine if oxaliplatin combined with docetaxel has a lower toxicity profile and to determine the response rate to this study drug combination.

Detailed description:
This study is a Phase II study designed to evaluate the toxicity profile for oxaliplatin and docetaxel and to determine the response rate to this study drug combination. The primary objective of the study is response rate by RECIST criteria. The secondary objective is time to progression, duration of response, and toxicity. Patients will receive:

* oxaliplatin 85mg/m2 over 2 hours on Days 1 and 15
* docetaxel 30mg/m2 on Days 1 and 8

Cycles are to be repeated every 28 days for a maximum of 6 cycles.

Arms: arm 1: Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer. The primary objective of the trial is to determine the response rate by RECIST criteria to the combination of oxaliplatin and docetaxel in patients with previously untreated NSCLC.
Interventions: intervention 1: Oxaliplatin + Docetaxel
Intervention descriptions: intervention 1: Oxaliplatin 85mg/m2 Docetaxel 30mg.m2

Protocol documents:
Clinical trial NCT00174460
Conditions: Growth Hormone Therapy Infant, Very Low Birth Weight
Sponsor: Pfizer
Start date: 2005-08-01; Completion date: 2010-03-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Safety and efficacy of Somatropin will be evaluated in short children born with a list weight below 1500 g and that did not catch up to normal height at the age of 4.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Somatropin intervention 2: Control Arm
Intervention descriptions: intervention 1: Controlled, prospective, randomized, multicenter study with an untreated (control) group during the first year. The children will be randomized into treatment or untreated (control) group. After one year the control group will undergo GH-therapy, too. Children randomized to the control group will get the possibility to continue treatment for a further year. The study will end after 2 and 3 years of observation, respectively. intervention 2: Controlled, prospective, randomized, multicenter study with an untreated (control) group during the first year. The children will be randomized into treatment or untreated (control) group. After one year the control group will undergo GH-therapy, too. The study will end after 2 and 3 years of observation, respectively. Children randomized to the control group will get the possibility to continue treatment for a further year.

Protocol documents:
Clinical trial NCT00185965
Conditions: Non-Hodgkin Lymphoma Mycosis Fungoides
Keywords: non-Hodgkin lymphoma mycosis fungoides
Sponsor: Ronald Levy
Start date: 2004-07-01; Completion date: 2010-03-01
Enrollment: 30 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Brief summary TBD

Detailed description:
This is a single institution phase 1-2 trial to evaluate the safety, feasibility and efficacy of CpG injections (4 intratumoral injections followed by 6 peri-tumoral injections) combined with local irradiation in patients with recurrent low-grade lymphomas.

Patients will receive low-dose radiotherapy to a single tumor site on days 1 and 2 (2 Gy each day). CpG injections will be administered into the same tumor site within the 24 hours before and the 24 hours after the radiation, and on days 8 and 15. Weekly doses of CpG will be then administered subcutaneously in the region of previous injections for 6 additional doses.

Arms: arm 1: Recurrent low-grade B-cell lymphoma patients (at least one prior treatment failure) arm 2: Mycosis fungoides patients must have failed or have been intolerant of at least 1 topical or 1 systemic treatment

Recurrent mycosis fungoides patients (at least one prior failure of topical or systemic treatment)
Interventions: intervention 1: CPG 7909
Intervention descriptions: intervention 1: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections).

Protocol documents:
Clinical trial NCT00217464
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate recurrent prostate cancer
Sponsor: Roswell Park Cancer Institute
Start date: 2004-06-01; Completion date: 2010-03-01
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Estrogen may cause the growth of prostate cancer cells. Hormone therapy using fulvestrant may fight prostate cancer by blocking the use of estrogen by the tumor cells.

PURPOSE: This phase II trial is studying how well fulvestrant works in treating patients with recurrent prostate cancer.

Detailed description:
OBJECTIVES:

Primary

* Determine whether fulvestrant can slow the rise of prostrate-specific antigen (PSA) level in patients with early recurrent adenocarcinoma of the prostate after radical prostatectomy or irradiation.

Secondary

* Determine the utility of monitoring serum PSA in patients treated with this drug.
* Determine the safety of this drug in these patients.
* Determine changes in bone mineral density and markers of bone resorption in patients with PSA-only failure treated with this drug.

OUTLINE: This is an open-label, single group assignment study.

Patients receive fulvestrant intramuscularly on days 0, 14, and 28. Treatment repeats once a month in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study for 84 months.

Arms: arm 1: Fulvestrant will be provided as 250 mg in 5 mL as a pre-tilled syringe. Fulvestrant will be administered as 500 mg, that is, 2 injections of 5 mL, one into each buttock im on day 0. A single 250 mg in 5 mL injection will be administered on day 14 followed by a single 250 mg in 5 mL dose on day 28 and monthly thereafter.
Interventions: intervention 1: fulvestrant
Intervention descriptions: intervention 1: intramuscularly

Protocol documents:
Clinical trial NCT00238303
Conditions: Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma Recurrent Adult Brain Tumor
Sponsor: National Cancer Institute (NCI)
Start date: 2005-09-01; Completion date: 2010-03-01
Enrollment: 103 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This phase II trial is studying how well vorinostat works in treating patients with progressive or recurrent glioblastoma multiforme. Drugs used in chemotherapy, such as vorinostat, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vorinostat before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving it after surgery may kill any remaining tumor cells.

Detailed description:
PRIMARY OBJECTIVES:

I. Determine the efficacy of vorinostat (SAHA), in terms of 6-month progression-free survival, in patients with progressive or recurrent glioblastoma multiforme.

II. Determine the safety and toxicity of this drug in these patients.

SECONDARY OBJECTIVES:

I. Determine the pharmacokinetics of this drug in these patients. II. Determine the biologic effect of this drug in target tissues, including primary tumor tissue, in these patients.

III. Correlate genetic alteration of tumors with response in patients treated with this drug.

OUTLINE: This is an open-label, multicenter study. Patients are stratified according to planned surgery (yes \[stratum 1\] vs no \[stratum 2\]) and number of prior chemotherapy regimens for progressive/recurrent disease (≤ 1 \[stratum 1A\] vs ≥ 2 \[stratum 1B\]).

STRATUM 1: Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. (not undergoing surgery)

STRATUM 2: Beginning 3 days prior to surgery, patients receive oral SAHA once or twice daily for a total of 6 doses. Patients then undergo surgery to remove the tumor. Beginning within 1-4 weeks after surgery, patients receive oral SAHA twice daily for 2 weeks. (undergoing surgery)

Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 5 years.

Arms: arm 1: Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. arm 2: Beginning 3 days prior to surgery, patients receive oral SAHA once or twice daily for a total of 6 doses. Patients then undergo surgery to remove the tumor. Beginning within 1-4 weeks after surgery, patients receive oral SAHA twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: vorinostat intervention 2: conventional surgery
Intervention descriptions: intervention 1: Given orally intervention 2: Patients undergo surgery to remove tumor

Protocol documents:
Clinical trial NCT00245063
Conditions: Recurrent Non-small Cell Lung Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2006-03-01; Completion date: 2010-03-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well AZD2171 works in treating patients with recurrent small cell lung cancer. AZD2171 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the objective response rate of AZD 2171 in patients with recurrent small cell lung cancer (SCLC).

SECONDARY OBJECTIVES:

I. To determine the overall survival and time to progression. II. To assess the toxicities associated with the administration of AZD 2171 for patients with recurrent SCLC.

III. To perform molecular correlative studies on archival tumor and peripheral blood.

OUTLINE: This is a multicenter study.

Patients receive oral AZD2171 once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 4 weeks.

Arms: arm 1: Patients receive oral AZD2171 once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: cediranib maleate intervention 2: laboratory biomarker analysis intervention 3: pharmacogenomic studies
Intervention descriptions: intervention 1: Given PO intervention 2: Correlative studies intervention 3: Optional correlative studies

Protocol documents:
Clinical trial NCT00265616
Conditions: Status Epilepticus
Keywords: Refractory status epilepticus, coma-induction, treatment, propofol, barbiturates, efficacy, safety.
Sponsor: Brigham and Women's Hospital
Start date: 2006-05-01; Completion date: 2010-03-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether propofol or barbiturates should be preferred in the treatment of status epilepticus (continuous seizure activity) refractory to 2 standard antiepileptic agents.

Detailed description:
Refractory status epilepticus (SE) develops in 31%-44% of patients with SE, with a mortality of 16%-23%. Coma induction is advocated for its management. Propofol and barbiturates are the most used agents, but no comparative study has been performed. In consideration of the uncertainty regarding the relative effectiveness, despite several retrospective data, a prospective investigation is needed.

The objective is to assess the effectiveness (SE control, adverse events) of a first course of propofol versus barbiturates in the treatment of refractory SE, in adults with refractory SE not due to cerebral anoxia.

Comparison: Coma induction with standardized doses of propofol or barbiturates titrated towards burst-suppression on EEG, then assessment of the proportion of patients achieving a control of SE.

Arms: arm 1: propofol, 2mg/kg as bolus, then titrated up to EEG burst-suppression as a continuous infusion; no maximum doses defined arm 2: thiopental/pentobarbital, 2mg/kg as bolus, then titrated up to EEG burst-suppression as a continuous infusion; no maximum doses defined
Interventions: intervention 1: propofol intervention 2: thiopental/pentobarbital
Intervention descriptions: intervention 1: liquid, mg/kg.h, titrated after EEG intervention 2: liquid, mg/kg.h, titrated after EEG

Protocol documents: