Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Behaviors and Mental Disorders

Lung Neoplasms

Pleural Effusion, Malignant

Pleural Effusion

Pleural Diseases

Respiratory Tract Diseases

Quality of Life

19 question M. D. Anderson Symptom Inventory (MDASI) before pleural effusion treatment and at each follow-up visit, takes about 5 minutes to complete each time.

MDASI Questionnaire

David Ost, MD

The goal of this clinical research study is to compare 2 different methods for treating a pleural effusion. Researchers also want to learn how the treatment you receive effects your quality of life (your ability to do the things you like to do and how happy you feel.

If you agree to take part in this study, you may be asked to fill out a questionnaire called the MD Anderson Symptom Inventory (MDASI) before your scheduled pleural effusion treatment procedure, 24 hours after your procedure, and then weekly for the next 4 months. During this time, a member of the study staff or a computer system will call you at home on your desired day and time to complete the questionnaire. The MDASI for lung-related symptoms has 22 questions about the possible symptoms caused by the disease, and how the symptoms may affect the activities of your daily life, which you will rate on a scale of 0-10. The MDASI will take about 5 minutes to complete each time.

You will also complete 2 questionnaires called the SF6D Patient Self Assessment and Borg Scale before your scheduled pleural effusion treatment procedure, 2 weeks later, and then 1 time a month for 1 year. These questionnaires are part of your standard of care. There are 7 questions total about how the symptoms may affect the activities of your daily life. If you are not in the clinic, a member of the study staff will call you at home on your desired day and time to complete the questionnaires. The questionnaires should take about 5 minutes total to complete each time.

Your information will be stored in a password-protected database for use in future research related to cancer for up to 5 years after the study is completed.

Before any of your information that is stored in the database can be used for research, the people doing the research must get specific approval from the Institutional Review Board (IRB) of MD Anderson. The IRB is a committee made up of doctors, researchers, and members of the community. The IRB is responsible for protecting the participants involved in research studies and making sure all research is done in a safe and ethical manner. All research done at MD Anderson, including research involving your data from this bank, must first be approved by the IRB.

Your information will be given a code number so that none of your personal identifying information will be directly linked to your information. Only the researcher in charge of the database will have access to the code numbers and be able to link the information in the database back to you. Other researchers who use the database will not be able to link your information or file back to you.

This is an investigational study. Up to 445 participants will be enrolled at MD Anderson.

Pleural Catheters Versus Thoracoscopic Pleurodesis

Comparative Effectiveness of Indwelling Pleural Catheters Versus Thoracoscopic Pleurodesis for Treatment of Malignant Pleural Effusions

Quality-adjusted time to death (measured as QALYs) for two patient groups (indwelling pleural catheters and thoracoscopy), calculated using Brazier's SF-6D utility measure described to determine utilities, then integrating utilities over time to arrive at quality-adjusted survival for each patient.

M. D. Anderson Symptom Inventory (MDASI) symptoms questionnaire: 19 questions about symptoms rated on a scale of 1-10.

M.D. Anderson Cancer Center

Nervous System Diseases

Symptoms and General Pathology

Blood and Lymph Conditions

Immune System Diseases

Diseases and Abnormalities at or Before Birth

Skin and Connective Tissue Diseases

Rare Diseases

Brain Neoplasms

Astrocytoma

Sclerosis

Lung Diseases

Seizures

Lymphangioleiomyomatosis

Tuberous Sclerosis

Angiomyolipoma

Hamartoma

Neoplasms, Multiple Primary

Syndrome

Neoplastic Syndromes, Hereditary

Congenital Abnormalities

Malformations of Cortical Development

Nervous System Malformations

Neurocutaneous Syndromes

Heredodegenerative Disorders, Nervous System

Neurodegenerative Diseases

Genetic Diseases, Inborn

Lymphangiomyoma

Neoplasms by Histologic Type

Perivascular Epithelioid Cell Neoplasms

Neoplasms, Connective and Soft Tissue

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Neoplasms, Adipose Tissue

Tuberous Sclerosis Complex

Subependymal Giant Cell Astrocytoma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Everolimus

Sirolimus

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Immunosuppressive Agents

Immunologic Factors

Study drug was given by continuous oral daily dosing of two 5 mg tablets.

Placebo was given by continuous oral daily dosing of two 5 mg tablets.

Everolimus is used in 5 mg strength tablets, blister-packed under aluminum foil in units of ten tablets and dosed on a daily basis. 10mg daily dosing throughout the trial.

Everolimus (RAD001)

Matching placebo was provided as a matching tablet and was also blister-packed under aluminum foil in units of ten.

Everolimus Placebo

Novartis Pharmaceuticals

This study will evaluate the safety and efficacy of RAD001 in treating patients with Angiomyolipoma associated with Tuberous Sclerosis Complex or Sporadic Lymphangioleiomyomatosis.

Efficacy and Safety of RAD001 in Patients Aged 18 and Over With Angiomyolipoma Associated With Either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM)

A Randomized, Double-blind, Placebo-controlled Study of RAD0001 in the Treatment of Angiomyolipoma in Patients With Either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM)

Angiomyolipoma response defined as the combination of the following criteria: reduction in angiomyolipoma volume of ≥ 50% relative to baseline, where angiomyolipoma volume was sum of volumes of all target lesions identified at baseline, and with a confirmatory scan performed approximately 12 weeks later (no sooner than 8 weeks later); no new angiomyolipoma lesions ≥ 1.0 cm in longest diameter were identified; there were no kidney increases in volume \> 20% from nadir. The patient did not have any angiomyolipoma-related bleeding of ≥ grade 2.

For the everolimus (core/extension periods) treatment group, the baseline means the latest value on or before starting everolimus.

Time to angiomyolipoma progression (TTAP) is defined as time from date of randomization to date of first documented angiomyolipoma progression. Angiomyolipoma progression was defined as one or more of the following: Increase from nadir of ≥ 25% in angiomyolipoma volume to value greater than baseline; the appearance of a new angiomyolipoma ≥ 1.0 cm in longest diameter; an increase from nadir of 20% or more in the volume of either kidney to a value greater than baseline; angiomyolipoma-related bleeding grade ≥ 2.

For the everolimus (core/extension periods) treatment group, the time to angiomyolipoma progression is defined starting from the start of everolimus. The baseline means the latest value on or before starting everolimus.

Skin lesion response rate in the double-blind period was determined only among patients with at least one skin lesion at baseline, and is the percentage of this group of patients with a best overall skin lesion response on the Physician's Global Assessment of Clinical Condition (PGA) of either complete clinical response (CCR) or partial response (PR). A complete clinical response (CCR) requires a grading of 0 indicating the absence of disease (histological confirmation is not required). Grades 1, 2, and 3 constitute partial response, indicating improvement of at least 50 percent, but less than 100 percent improvement. For the everolimus (core/extension periods) treatment group, the baseline means the latest value on or before starting everolimus.

Renal Impairment was measured by glomerular filtration rate which was calculated using the Modification of Diet in Renal Disease formula. Percentage of participants with renal impairment was reported. Severe renal impairment was defined as a GFR of \<30ml/min/1.73m2.

Blood samples for biomarker assessment were collected immediately prior to study administration. On-treatment samples was compared to baseline samples with the change from baseline.

Cmin values collected prior to dose administration on the same study day and at 20-28 hours after previous dose, at steady state, and patient did not vomit within 4 hours of previous dose. Samples collected during the first 4 days of dosing were excluded from all analyses.

C2h values collected 1-3 hours after dose administration on the same study day, at steady state, and patient did not vomit between taking previous dose and blood collection. Samples collected during the first 4 days of dosing will be excluded from all analyses.

Time to angiomyolipoma response was defined as the time from the date of randomization until the date of the first documented angiomyolipoma response. Angiomyolipoma response defined as the combination of the following criteria: reduction in angiomyolipoma volume of ≥ 50% relative to baseline, where angiomyolipoma volume was sum of volumes of all target lesions identified at baseline, and with a confirmatory scan performed approximately 12 weeks later (no sooner than 8 weeks later); no new angiomyolipoma lesions ≥ 1.0 cm in longest diameter were identified; no kidney increases in volume \> 20% from nadir; no angiomyolipoma-related bleeding of ≥ grade 2.

For the everolimus (core/extension periods) treatment group, the time to angiomyolipoma response is from the start of everolimus. The baseline in the response definition means the latest value on or before starting everolimus.

Duration of angiomyolipoma response was defined as the time from the date of the first documented angiomyolipoma response until the date of the first documented angiomyolipoma progression . Angiomyolipoma response was defined as the combination of the following criteria: reduction in angiomyolipoma volume of ≥ 50% relative to baseline, where angiomyolipoma volume was sum of volumes of all target lesions identified at baseline, and with a confirmatory scan performed approximately 12 weeks later (no sooner than 8 weeks later); no new angiomyolipoma lesions ≥ 1.0 cm in longest diameter were identified; there were no kidney increases in volume \> 20% from nadir. The patient did not have any angiomyolipoma-related bleeding of ≥ grade 2.

Duration of skin lesion response is defined as the time from the date of the first skin lesion response until the date of the first skin lesion progression, according to the PGA (physician's global assessment of clinical condition). A progression is when the disease is worse than at baseline evaluation by \>=25% or more.

Patients who were randomized and treated with Everolimus during the Core and Extension phase

Everolimus Randomized (Core & Ext)

Patients who were randomized to placebo in the Core phase and who crossed-over to Everolimus in the Extension phase

Placebo Randomized/Crossed Over to Everolimus

Patients randomized to placebo who never crossed-over to Everolimus

Placebo Randomized/Never Crossed-over

Placebo

Total

Age, Continuous

<30 years

≥ 30 years

Age, Customized

Gender

Everolimus Randomized (Core Period)

Placebo Randomized (Core Period)

Patients initially randomized in everolimus and patients initially randomized in placebo but who crossed-over to everolimus during extension.

Everolimus (Core and/or Extension Period)

The Full Analysis Set (FAS) is defined according to the Intention-to-Treat principle and consists of all randomized patients.

Angiomyolipoma Response Rate as Per Central Radiology Review

Time to Angiomyolipoma Progression as Per Central Radiology Review

The Full Analysis Set (FAS) is defined according to the Intention-to-Treat principle and consists of all randomized patients. Only patients with at least one skin lesion at baseline are included in the analysis.

Skin Lesion Response Rate as Per Investigator (Only Patients With at Least One Skin Lesion at Baseline)

Glomerular filtration rate <30 ml/min/1.73m^2

Glomerular filtration rate≥ 30 ml/min/1.73m^2

Safety set consists of all patients who received at least 1 dose of the double-blind study drug with a valid post-baseline assessment. For the everolimus (core/extension) treatment arm, patients received at least 1 dose of everolimus with a valid post-baseline assessment, where baseline was defined as the assessment just before start of everolimus.

Percentage of Participants With Renal Impairment

Week 4 (n:56, 28)

Week 12 (n:56, 29)

Week 24 (n:53, 29)

Week 36 (n:26, 18)

Week 48 (n:16, 8)

Week 60 (n:0, 1)

Week 72 (n:0, 1)

The Full Analysis Set (FAS) is defined according to the Intention-to-Treat principle and consists of all randomized patients. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.

Change From Baseline in Plasma Angiogenic Molecules - Vascular Endothelial Growth Factor (VEGF) Marker

Prior to dosing at Week 2 (n:43)

Prior to dosing Week 4 (n:44)

Prior to dosing Week 12 (n:49)

Prior to dosing Week 24 (n:46)

Prior to dosing Week 48 (n:15)

The analysis was performed in the Safety Set population for patients treated only with Everolimus and with a confirmed PK sample.

Everolimus Trough Concentrations (Cmin)

2 hours post dose administration at Week 2 (n:55)

2 hours post dose administration at Week 4 (n:49)

2 hours post dose administration at Week 12 (n:56)

2 hours post dose administration at Week 24 (n:50)

2 hours post dose administration at Week 48 (n:14)

Everolimus Blood Concentrations (C2h) at 2 Hours Post-dose

The analysis was performed on the Full analysis Set for patients in Everolimus arm and who experienced an angiomyolipoma response.

Time to Angiomyolipoma Response - Only Everolimus Patients With Angiomyolipoma Response

Duration of Angiomyolipoma Response - Only Everolimus Patients With Angiomyolipoma Response

The analysis was performed on the Full analysis Set for patients in Everolimus arm and who experienced a best overall skin lesion response CCR or PR.

Duration of Skin Lesion Response - Only Everolimus Patients With Best Overall Skin Lesion Response of Complete Clinical Response (CCR) or Partial Response (PR)

Double-blind Period (Core Phase)

Everolimus Period (Core or Extension)

Carcinoma

Carcinoma, Neuroendocrine

Neuroendocrine Tumors

Carcinoid Tumor

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neuroendocrine Tumor

Neuroepithelioma

Hematinics

Herbal and Botanical

Liver Extracts

Pasireotide

Hormones

Hormone Antagonists

Cola

The investigational drug used in this study is pasireotide long acting release (LAR) 60 mg.

Pasireotide will be administered as an intramuscular injection at the beginning of every cycle which is defined as 28 days (+/- 3 days). Study treatment should begin within 14 days following enrollment into the study and continue until disease progression, unacceptable toxicity, or withdrawal of consent.

Pasireotide Long Acting Release (LAR)

Jonathan Strosberg, M.D.

The goal of this clinical research study is to learn if the study drug, Pasireotide LAR can shrink or slow the growth of Metastatic Neuroendocrine Carcinomas. The safety of this drug will also be studied. The patient's physical state, changes in the size of the tumor, and laboratory findings taken while on-study will help us decide if Pasireotide LAR is safe and effective.

This is a multi-institutional, prospective phase II open-label trial.

The investigational drug used in this study is pasireotide LAR 60 mg. Pasireotide will be administered as an intramuscular injection at the beginning of every cycle which is defined as 28 days (+/- 3 days). Study treatment should begin within 14 days following enrollment into the study and continue until disease progression, unacceptable toxicity, or withdrawal of consent. Safety and efficacy will be assessed throughout the treatment period.

Study of Pasireotide Long Acting Release (LAR) in Patients With Metastatic Neuroendocrine Tumors (NETs)

Phase II Study of Pasireotide LAR in Patients With Metastatic Neuroendocrine Carcinomas

PFS: Defined as the time from the date of first study treatment to the date of the first documented disease progression, by Response Evaluation Criteria in Solid Tumors (RECIST 1.0) guidelines, or death due to any cause. Progressive Disease (PD): at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.

Complete response (CR): complete disappearance of all target lesions, confirmed by repeat assessments at no less than 4 weeks after the criteria for response are first met. Partial response (PR): at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. This must be confirmed by repeat assessment at no less than 4 weeks after the criteria for response are first met. Stable Disease (SD): neither sufficient decrease to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started.

Adverse Events (AEs) and Serious Adverse Events (SAEs) will be evaluated continuously throughout the study. Safety and tolerability will be assessed according to the NIH/NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0).

RECORDATI GROUP

H. Lee Moffitt Cancer Center and Research Institute

The investigational drug used in this study is pasireotide long acting release (LAR) 60 mg.

Pasireotide Long Acting Release (LAR): Pasireotide will be administered as an intramuscular injection at the beginning of every cycle which is defined as 28 days (+/- 3 days). Study treatment should begin within 14 days following enrollment into the study and continue until disease progression, unacceptable toxicity, or withdrawal of consent.

Pasireotide LAR Treatment

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Jonathan Strosberg, MD

Progression-free Survival (PFS) at One Year

Partial Response

Stable Disease

Progressive Disease

Overall Radiographic Response Rate (ORR)

All participants who received at least one dose of study drug

Adverse Events Possibly Related to Study Treatment

Overall Study

Amino Acids

Axitinib

Tyrosine

The investigational drug used in this study is axitinib, and is available as tablets.

You will take the tablet orally with food. Doses should be taken around 12 hours apart continuously, without scheduled breaks. If you vomit anytime after taking a dose do not take another tablet to "make up the dose" but instead continue taking your next dose as planned.

Any missed dose may be taken late (up to 3 hours before the next scheduled dose); otherwise it should be skipped. If doses are missed or vomited, please keep track of this and report at your next visit.

Axitinib Administration as outlined in Arm description

The main purpose of this study is to see whether Axitinib will help prolong the time that the patient's carcinoid tumors remain stable, and to examine their treatment response through testing. Researchers also want to find out if Axitinib is safe and tolerable.

This is a bi-institutional, prospective phase II, open-label study. The target population is comprised of adult patients with histologically confirmed unresectable or metastatic carcinoid tumors. Carcinoid tumors are defined as well to moderately differentiated neuroendocrine tumors of the digestive tract and lungs. Patients with metastatic carcinoid tumors of unknown primary as well as rare primaries (renal, ovarian, thymic, hepatic) will also be eligible. Patients will be drawn from two institutions Moffitt Cancer Center (MCC) and The University of California, San Francisco (UCSF).

A Study of Axitinib in Advanced Carcinoid Tumors

A Phase II Study of Axitinib in Advanced Carcinoid Tumors

Progression-free survival rate at 12 months. PFS: determined as the time from administration of the initial dose of axitinib until objective tumor progression using Response Evaluation Criteria In Solid Tumors (RECIST), or death. Progressive Disease (PD) Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase. Stable Disease (SD): Neither sufficient shrinkage to qualify for Partial Response (PR) nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pleural Catheters Versus Thoracoscopic Pleurodesis	NCT01117740	Lung Cancer	MDASI Questionn...	18 Years -	M.D. Anderson Cancer Center
Efficacy and Safety of RAD001 in Patients Aged 18 and Over With Angiomyolipoma Associated With Either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM)	NCT00790400	Tuberous Sclero... Lymphangioleiom...	Everolimus (RAD... Everolimus Plac...	18 Years -	Novartis
Study of Pasireotide Long Acting Release (LAR) in Patients With Metastatic Neuroendocrine Tumors (NETs)	NCT01253161	Neuroendocrine ... Carcinoid Tumor...	Pasireotide Lon...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
A Study of Axitinib in Advanced Carcinoid Tumors	NCT01435122	Carcinoid Tumor	Axitinib	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
A Study of Axitinib in Advanced Carcinoid Tumors	NCT01435122	Carcinoid Tumor	Axitinib	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Study of Pasireotide Long Acting Release (LAR) in Patients With Metastatic Neuroendocrine Tumors (NETs)	NCT01253161	Neuroendocrine ... Carcinoid Tumor...	Pasireotide Lon...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Pleural Catheters Versus Thoracoscopic Pleurodesis	NCT01117740	Lung Cancer	MDASI Questionn...	18 Years -	M.D. Anderson Cancer Center
Pleural Catheters Versus Thoracoscopic Pleurodesis	NCT01117740	Lung Cancer	MDASI Questionn...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for lungs

Every month we try and update this database with for lungs 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 lungs

Every month we try and update this database with for lungs 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 lungs 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.