Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Recurrence

Disease Progression

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Aromatase Inhibitors

Patients will receive eribulin injections intravenously on days 1 and 8 of every 21- day cycle

Patients will receive eribulin injections intravenously on days 1 and 8 of every 21- day cycle, in combination with endocrine therapy (aromatase inhibitor). AI must be identical to the last AI administered to the patient, whether in the adjuvant or metastatic setting.

Patients will receive eribulin injections intravenously on days 1 and 8 of every 21-day cycle alone.

Eribulin

Javier Cortés, PhD

Unresectable, ER-positive and/or PR-positive and HER2-negative locally-recurrent or metastatic breast cancer (mBC).

Pre- and post-menopausal women age ≥ 18 years with unresectable, ER-positive and/or PR-positive and HER2-negative locally-recurrent or metastatic breast cancer (mBC) with no prior line of chemotherapy in the metastatic setting, and that have shown progression while on an aromatase inhibitor-containing regimen in the metastatic setting or within six months from last aromatase inhibitor dose in the adjuvant setting. Patients must have received at least one taxane or anthracycline regimen in either the adjuvant or the neoadjuvant setting. Subjects must have adequate bone marrow and creatinine clearance functions.

Trial With Eribulin or Eribulin+ Endocrine Therapy in Locally-recurrent or Metastatic Breast Cancer Patients

A Multicenter, Randomized, Phase II Trial Evaluating the Efficacy of Eribulin Monotherapy and Eribulin Plus Endocrine Therapy in Locally-recurrent or Metastatic Breast Cancer Patients After Progression on Endocrine Therapy (REVERT)

The overall response rate (ORR) in the eribulin + ET arms, defined as the proportion of patients with best overall response of confirmed complete response or partial response based on local investigator's assessment according to Response Evaluation Criteria In Solid Tumours (RECIST) criteria v. 1.11.

The progression-free survival (PFS) for patients treated with endocrine therapy alone or in combination with eribulin is defined as the time from randomization until death by any cause or objective tumor progression based on local investigator's assessment according to Response Evaluation Criteria In Solid Tumours (RECIST) criteria v. 1.11.

The PFS-2, in the eribulin and the eribulin + ET arms, defined as the time from the randomization to the second disease progression or death, i.e., PFS after the next line of treatment, based on local investigator's assessment according to Response Evaluation Criteria In Solid Tumours (RECIST) criteria v. 1.11.

The overall response rate (ORR) in the eribulin arm, defined as the proportion of patients with best overall response of confirmed complete response or partial response based on local investigator's assessment according to Response Evaluation Criteria In Solid Tumours (RECIST) criteria v. 1.11.

The duration of response (DOR) in the eribulin and the eribulin + ET arms, defined as the time from the start of the treatment to disease progression based on local investigator's assessment according to Response Evaluation Criteria In Solid Tumours (RECIST) criteria v. 1.11.

The clinical benefit rate (CBR) in the eribulin and the eribulin + ET arms, defined as the proportion of patients with no disease progression after 6 months of therapy, based on local investigator's assessment according to Response Evaluation Criteria In Solid Tumours (RECIST) criteria v. 1.11.

The overall survival (OS) in the eribulin and the eribulin + ET arms, defined as the length of time that patients remain alive from the start of treatment (OS will be collected at the end of the study).

Maximum Tumor shrinkage, defined as the percentage of tumor shrinkage from baseline (obtained from the sum of the largest diameters of the target lesions), based on local investigator's assessment according to RECIST criteria guidelines (version 1.1)1.

MedSIR

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Lymphoma

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Antineoplastic Agents

Antirheumatic Agents

Anti-Inflammatory Agents

Cyclophosphamide

Prednisone

Rituximab

Vincristine

Epirubicin

Antineoplastic Agents, Immunological

Immunologic Factors

(R)-CHOP regimen((rituximab)，cyclophosphamide，epirubicin，vincristine and prednisone)，(rituximab 375mg/m2 d0 ivgtt),cyclophosphamide 750mg/m2 d1、8 ivgtt,epirubicin 50mg/m2 d1、8 ivgtt,vincristine 2mg d1、8 ivgtt,prednisone 60mg d1-5 po.Every 21 days for one cycle and six cycles are required. Efficacy was evaluated every two cycles.

(R)-CVP regimen((rituximab)，cyclophosphamide，vincristine and prednisone) The dose of the chemical was reduced by 20%，(rituximab 375mg/m2 d0 ivgtt),cyclophosphamide 750mg/m2 d1、8 ivgtt,vincristine 2mg d1、8 ivgtt,prednisone 60mg d1-5 po.Every 21 days for one cycle and one or two cycles are required. Efficacy was evaluated every two cycles. Subsequent (rituximab 375mg/m2 d0 ivgtt)， oral cyclophosphamide .

(rituximab 375mg/m2 d0 ivgtt),cyclophosphamide 750mg/m2 d1、8 ivgtt,epirubicin 50mg/m2 d1、8 ivgtt,vincristine 2mg d1、8 ivgtt,prednisone 60mg d1-5 po.Every 21 days for one cycle and six cycles are required. Efficacy was evaluated every two cycles.

(R)-CHOP regimen

The dose of the chemical was reduced by 20%，(rituximab 375mg/m2 d0 ivgtt),cyclophosphamide 750mg/m2 d1、8 ivgtt,vincristine 2mg d1、8 ivgtt,prednisone 60mg d1-5 po.Every 21 days for one cycle and one or two cycles are required. Efficacy was evaluated every two cycles. Subsequent (rituximab 375mg/m2 d0 ivgtt)， oral cyclophosphamide .

(R)-CVP regimen

Mingzhi zhang, Pro,Dr

Mingzhi zhang

Mingzhi Zhang, Pro,Dr

To explore the clinical features and efficacy evaluation of large b-cell lymphoma in old age.

The results of the analysis of the treatment of large b-cell lymphoma in old age were analyzed, and the treatment of large B cell lymphoma was provided.

Treatment of Elderly Patients With Diffuse Large B-cell Lymphoma

Mingzhi Zhang

the director of oncology department of the first affiliated hospital

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Carcinoma, Renal Cell

Kidney Neoplasms

Neoplasms, Glandular and Epithelial

Adenocarcinoma

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Anti-Infective Agents

Anti-Allergic Agents

Antiemetics

Central Nervous System Depressants

Gastrointestinal Agents

Dermatologic Agents

Sirolimus

Diphenhydramine

Promethazine

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Immunosuppressive Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Clotrimazole

Miconazole

Antifungal Agents

Hypnotics and Sedatives

Anesthetics

Anesthetics, Local

Histamine H1 Antagonists

Histamine

Histamine phosphate

Histamine Antagonists

Neurotransmitter Agents

Pazopanib 800 mg by mouth daily. Quality of Life Assessment - Completion of full assessment battery at baseline, prior to treatment then every 8 weeks at clinical evaluation.

Temsirolimus 25 mg by vein infused over 30-60 minutes weekly. Benadryl 25 to 50 mg by vein approximately 30 minutes before the start of each dose of temsirolimus. Quality of Life Assessment - Completion of full assessment battery at baseline, prior to treatment then every 8 weeks at clinical evaluation.

800 mg by mouth daily in 4 week study cycle.

Pazopanib

25 mg by vein infused over 30-60 minutes every week in 4 week study cycle.

Completion of full assessment battery at baseline, prior to treatment then every 8 weeks at clinical evaluation.

Quality of Life Assessment

25 to 50 mg by vein approximately 30 minutes before the start of each dose of temsirolimus.

Benadryl

Amado Zurita, MD

The goal of this clinical research study is to compare pazopanib to temsirolimus in the treatment of advanced clear-cell renal cell carcinoma. The safety of each drug will also be studied.

Pazopanib is designed to block the growth of blood vessels that supply nutrients needed for tumor growth. This may prevent or slow the growth of cancer cells.

Temsirolimus is designed to block the growth of cancer cells, which may cause cancer cells to die.

This is an investigational study. Pazopanib and temsirolimus are both FDA approved and commercially available for the treatment of kidney cancer. It is investigational to compare the 2 drugs.

Up to 90 patients will be enrolled in this study. All will be enrolled at MD Anderson.

Study Groups and Study Drug Administration:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. You will have an equal chance of being assigned to either group.

* If you are assigned to Group 1, you will take pazopanib by mouth 1 time every day at about the same time each day on an empty stomach (at least 1 hour before or 2 hours after a meal).
* If you are assigned to Group 2, you will receive temsirolimus by vein 1 time every week over 30-60 minutes. About 30 minutes before you receive each dose of temsirolimus, you will receive Benadryl (diphenhydramine) by vein over 1-2 minutes to help lower the risk of side effects.

If you are assigned to Group 1, do not crush tablets and do not repeat missed doses if it is less than 12 hours until your next scheduled dose. You will be given a pill diary to record when you take each dose. You will return the diary to the study doctor at each study visit.

If you have any side effects, you should tell the study doctor right away. If the study doctor thinks it is in your best interest, your dose may be lowered.

If the disease gets worse while you are on study, you will have the option to change to the study group you were not originally assigned to and take the other study drug. The study drug dosing and study visit schedule will be the same, and the study doctor will discuss any important details with you at the time you change study groups.

Study Visits:

Every 4 weeks on this study is called a study cycle.

Every week during Cycle 1 (Group 1 only), your blood pressure will be checked (either at home, at the clinic, or by your local doctor). If you are checking your own blood pressure at home, you will need to write down your blood pressure in a blood pressure diary each time you check it and bring the diary with you to each clinic visit.

Every 2 weeks for the first 2 cycles (Group 1 only) , blood (about 3 tablespoons) will be drawn for routine tests.

Every week (Group 2 only), blood (about 1 tablespoon) will be drawn for routine tests.

Every cycle (Group 2 only) OR Every other cycle (Group 1 only):

* You will have a physical exam, including measurement of your weight and vital signs.
* You will be asked about any drugs or treatments you may be receiving.
* You will be asked about any side effects you may have had.
* Blood (about 3 tablespoons) will be collected for routine tests.

On Day 1 of Cycle 2, Day 1 of Cycle 4, and every 4 cycles after that (Group 1 only), you will have an ECG to check your heart function.

If you are in Group 2 only, on Day 1 of Cycles 2, 3, and every other cycle after that (Cycles 5, 7, 9, and so on), blood (about 3 tablespoons) will be drawn for routine tests. You will be asked to fast (eat nothing and drink only water) for at least 8 hours before those blood draws.

Every 2 cycles:

* You will have the same imaging scans that you had at screening. After 1 year on treatment, these imaging scans may only be done every 3 cycles (Cycles 5, 8, 11, and so on).
* You will fill out the quality-of-life questionnaires.
* Blood (about 2 teaspoons) will be drawn for tests to check your thyroid function (Group 1 only).
* Urine will be collected for routine tests.

Every 4 cycles, you will have an ECG (Group 2 only).

Every 6 cycles, you will have an ECHO or MUGA scan to check your heart function.

Length of Study:

You may continue taking the study drug for as long as the doctor thinks it is in your best interest. You will no longer be able to take a study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

End-of-Treatment Follow- up:

About 30 days after you stop treatment, during a clinic visit or by phone, you will be asked about any drugs or treatments you may be receiving and any side effects you may have had.

Long-Term Follow-up:

After you stop taking the study drug, the study staff will check up on you to ask how you are doing about every 3 months from then on. The study staff will collect the information they need either from your medical records or by calling you. If you are contacted by phone, the call should only last about 5 minutes.

Pazopanib Versus Temsirolimus in Poor-Risk Clear-Cell Renal Cell Carcinoma (RCC)

A Randomized Phase 2 Trial of Pazopanib Versus Temsirolimus in Poor-Risk Clear-Cell Renal Cell Carcinoma

PFS is measured from the initiation of treatment to the time of first disease progression or death due to any reason during the first drug administration in each arm. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% or more increase in the sum of the longest diameters of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions. The PFS median of first drug pazopanib (treatment group) was compared to the PFS median of first drug temsirolimus (control group) in an adjusted Hazard ratio. The hazard ratio compares events from a treatment group to a control group. If the hazard ratio is greater than 1the treatment group performed better. If the hazard ratio is less than 1 the control group performed better. If the hazard ratio is equal to 1, then the groups performed equally.

Overall survival is calculated from day of therapy initiation of the first administrated drug to the date of death. Kaplan-Meier estimator used to estimate the OS for each group of participants. The Overall Survival median of first drug pazopanib (treatment group) was compared to the Overall Survival median of first drug temsirolimus (control group) in an adjusted Hazard ratio. The hazard ratio compares events from a treatment group to a control group. If the hazard ratio is greater than 1the treatment group performed better. If the hazard ratio is less than 1 the control group performed better. If the hazard ratio is equal to 1, then the groups performed equally.

Novartis

M.D. Anderson Cancer Center

The total at Risk are participants who received the intervention as their first drug or second drug. All participants did not received both drugs.

Temsirolimus 25 mg intravenously weekly. Upon progression patient crosses over to pazopanib 800 mg orally daily. Treatments stop for progression, toxicity, withdrawal, or death.

Temsirolimus (Control Group)

Pazopanib 800 mg orally daily. Upon progression patient crosses over to temsirolimus 25 mg intravenously weekly. Treatments stop for progression, toxicity, withdrawal, or death.

Pazopanib (Treatment Group)

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

100%

The KPS score measures the participant's ability to perform ordinary tasks from 100 % - 0%. 100% no signs of disease, 90% minor signs or symptoms of disease, 80% normal activity with effort, 70% cannot do normal daily activities, 60% requires occasional assistance, 50% requires considerable assistance and frequent medical care, 40% disabled requires special care, 30% severely disabled; hospital admission is indicated, 20% very sick; hospital admission needed for active supportive treatment, 10% fatal processes progressing rapidly, and 0% death.

Karnofsky Performance Status (KPS) Score

ECOG measures how how the disease impacts a participant's daily living abilities such as self-care, daily living activity, and physical ability. The scores ranges from grade 0-5: 0 fully active; 1 restricted in physically strenuous activity but can walk; 2 can walk, capable of all self-care, but cannot do any work activities; 3 capable of only limited self-care and confined to bed or chair more than 50% of waking hours; 4 completely disabled, cannot carry on any self-care, totally confined to bed or chair; and 5 death.

Eastern Cooperative Oncology Group (ECOG) Performance Score

3 Factors

4 Factors

5 Factors

Participants were considered poor risk with at least 3 factors. The more risk factors the poorer the risk. The factors were any combination of an ECOG grade 2, anemia, high lactate dehydrogenase levels, high calcium levels, less than 1 year from diagnosis to the date of registration on this trial, or more than one organ with metastatic disease.

Poor -Risk With Disease Eligibility Score.

Favorable risk

Intermediate risk

Poor Risk

The IMDC score determines the overall survival in participants treated with cancer medications. The score is based on the 6 following factors: less than 1 year from time of diagnosis to trial registration, KPS score of 80% or less, anemia, high levels of calcium, high levels of neutrophils (a type of white blood cell), and a high level of platelets. The scores ranges from 0 - 6. A favorable risk score is 0. An intermediate risk score is 1 - 2. A poor risk score is 3 - 6.

International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) Risk Score

Amado J. .Zurita-Saavedra, MD/ Associate Professor, Genitourinary Medical Oncology

Pazopanib 800 mg orally daily. Upon progression patient crosses over to temsirolimus 25 mg intravenously weekly. Treatments stop for progression, toxicity, withdrawal, or death

The ratio is comparing both arms to each other, therefore the data would be identical.

Progression Free Survival (PFS)

Temsirolimus 25 mg intravenously weekly. Upon progression patient crosses over to pazopanib 800 mg orally daily. Treatments stop for progression, toxicity, withdrawal, or death

Pazopanib 800 mg orally daily. Pazopanib 800 mg orally daily. Upon progression patient crosses over to temsirolimus 25 mg intravenously weekly. Treatments stop for progression, toxicity, withdrawal, or death

Overall Survival (OS)

Temsirolimus 25 mg intravenously weekly. Upon progression patient crosses over over to pazopanib 800 mg orally daily. Treatments stop for progression, toxicity, withdrawal, or death.

First Drug Administration

Second Drug Administration

Nervous System Diseases

Prostatic Neoplasms

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Estrogens

Progesterone

18F-fluoroacetate injection as a single intravenous bolus with a maximum volume of 4 mL followed by a saline flush of 20 to 50 mL.

18F-fluoroacetate

Donald Podoloff, MD, BA

The goal of this clinical research study is to find out the highest tolerable dose of an imaging solution called 18-F-fluoroacetate sodium that can be given before a positron emission tomography (PET) scan. The safety of this solution will also be studied.

The Study Solution:

18-F-fluoroacetate sodium is designed to be attracted to cells that grow in some tumors. This imaging solution has a small dose of radiation added to it, which may help the doctor to "see" cancer cells and their possible spread through the body, during the scans. This is the first study using 18-F-fluoroacetate sodium in humans.

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to an imaging study date. The first group of 6 participants will receive a smaller dose of solution (less than one half of the regular PET scan tracer radioactivity). The later 2 groups may receive the same dose of solution or a larger dose, but the larger dose will still be no more than what you would receive in a regular clinic PET scan procedure.

Study Solution Administration and PET Scans:

On Day 1, you will receive 18-F-fluoroacetate sodium by vein over 5 minutes.

You will then have 3 PET scans with a PET/CT scanner. You will be lying down during the PET scan. Each scanning period will take about 1 hour. You will have a 20-minute rest period between each scan.

Before each PET scan, you will have a CT scan, called a "Scout View", to check your position in the machine. This should take about 5 minutes.

You may continue receiving standard treatment from your regular doctor throughout the entire time you are in this study.

Study Visits:

On Day 1 (the day of the injection and imaging study):

* You will have an ECG, your vital signs will be measured, and the injection site will be checked at 5 minutes before, and 30 minutes and 2 ½ hours after the imaging solution is injected.
* You will be asked if you have had any side effects.
* Blood (about 2 tablespoons total) will be drawn 9 times over 2 ½ hours after the injection for pharmacokinetic (PK) testing. PK testing measures the amount of the imaging solution in the body at different time points.
* Urine will also be collected to test the amount of radiation that might have been absorbed by the body. This will be collected during the 10 minute rest periods.

On Day 2:

* Your vital signs will be measured.
* You will have an ECG.
* Blood (about 2-3 tablespoons) will be drawn for routine tests.
* The injection site will be checked.
* You will be asked if you have had any side effects.

On Day 7:

* You will have a physical exam, including measurement of your vital signs.
* You will have an ECG.
* Blood (about 2-3 tablespoons) will be drawn for routine tests.
* The injection site will be checked.
* You will be asked if you have had any side effects.

On about Day 30:

* You will have a physical exam, including measurement of your vital signs.
* You will have an ECG.
* Blood (about 2-3 tablespoons) will be drawn for routine tests.
* The injection site will be checked.
* You will be asked if you have had any side effects.

Length of Study:

You will be on active study for the day you receive the imaging and 18-F-fluoroacetate sodium. You will be on follow-up for up to 30 days after the imaging.

This is an investigational study. 18-F-fluoroacetate sodium is not FDA approved or commercially available. At this time, it is being used in research only. The study scans are also considered investigational when used for this purpose, and will not be used for planning your cancer treatment.

Up to 18 patients will take part in this study. All will be enrolled at M. D. Anderson.

18-F-Fluoroacetate as PET Imaging Agent

A Phase I Study of 18-F-Fluoroacetate Sodium as a PET Imaging Agent for Tumor Detection

Biodistribution of 18F-fluoroacetate is measured during imaging, using a radioisotope (18F) of fluoroacetate PET scan. The percent injected dose (%ID) obtained in different organs derived from the PET data.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Trial With Eribulin or Eribulin+ Endocrine Therapy in Locally-recurrent or Metastatic Breast Cancer Patients	NCT03795012	Breast Cancer	Eribulin	18 Years -	MedSIR
Treatment of Elderly Patients With Diffuse Large B-cell Lymphoma	NCT03513601	Diffuse Large B...	(R)-CHOP regime... (R)-CVP regimen	70 Years - 85 Years	Zhengzhou University
Pazopanib Versus Temsirolimus in Poor-Risk Clear-Cell Renal Cell Carcinoma (RCC)	NCT01392183	Kidney Cancer	Pazopanib Temsirolimus Quality of Life... Benadryl	18 Years -	M.D. Anderson Cancer Center
Pazopanib Versus Temsirolimus in Poor-Risk Clear-Cell Renal Cell Carcinoma (RCC)	NCT01392183	Kidney Cancer	Pazopanib Temsirolimus Quality of Life... Benadryl	18 Years -	M.D. Anderson Cancer Center
18-F-Fluoroacetate as PET Imaging Agent	NCT01320787	Brain Cancer Breast Cancer Prostate Cancer	18F-fluoroaceta...	18 Years -	M.D. Anderson Cancer Center
The Study for Evaluating the Clinical Effectiveness and Safety of Respiratory Rehabilitation Software 'Redpill Breath'(COPD, Asthma, Lung Cancer, Etc.)	NCT05299385	Respiratory Sys... Chronic Obstruc... Asthma Copd Lung Cancer Lung Diseases Pulmonary Rehab... Respiratory Reh... Home Based Reha... Mobile Applicat... Rehabilitation	Conventional re... Digital treatme...	19 Years - 80 Years	Lifesemantics Corp.
Treatment of Elderly Patients With Diffuse Large B-cell Lymphoma	NCT03513601	Diffuse Large B...	(R)-CHOP regime... (R)-CVP regimen	70 Years - 85 Years	Zhengzhou University
Treatment of Elderly Patients With Diffuse Large B-cell Lymphoma	NCT03513601	Diffuse Large B...	(R)-CHOP regime... (R)-CVP regimen	70 Years - 85 Years	Zhengzhou University

Spots Global Cancer Trial Database for pr

Every month we try and update this database with for pr cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for pr

Every month we try and update this database with for pr cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for pr cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.