Neoplasms

All Conditions

Rare Diseases

Carcinoma

Carcinoma, Neuroendocrine

Neuroendocrine Tumors

Carcinoid Tumor

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neuroendocrine Tumor

Neuroepithelioma

Hematinics

All Drugs and Chemicals

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).

Novartis Pharmaceuticals

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

Digestive System Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Antineoplastic Agents

14-O-phosphonooxymethyltriptolide disodium salt

Antineoplastic Agents, Alkylating

Alkylating Agents

A Phase 1, Multi-Center, Open-label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of Minnelide™ given daily for 21 days followed by 7 days off schedule in patients with Advanced GI Tumors

Minnelide™ will be given as a single agent intravenously as a 30-minute infusion daily x 21 days followed by a 7-day rest period. One cycle will equal 28 days.

Minnelide™ 001

Mohana Velagapudi, MD

Linda Vocila, BSN

The primary objective of this study is to determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLT) of Minnelide™ and to establish the dose of Minnelide™ recommended for future phase 2 protocol

This is a Phase 1, open label, multicenter, dose-escalation study of safety, pharmacokinetics, and pharmacodynamics of Minnelide™

Minnelide™ will be given as a single agent intravenously as a 30-minute infusion daily x 21 days followed by a 7-day rest period. One cycle will equal 28 days. Dose escalation will follow a modified Fibonacci design.

Study of Minnelide™ in Patients With Advanced GI Tumors

A Phase 1, Multi-Center, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Minnelide™ Given Daily for 21 Days Followed by 7 Days Off Schedule in Patients With Advanced GI Tumors.

The MTD will be determined using a 3 + 3 design and will continue until 2 patients at any dose level experience a DLT. A DLT will be defined as Grade 4 neutropenia lasting ≥ 5 days or Grade 3 or 4 neutropenia with fever and/or infection;Grade 4 thrombocytopenia (or Grade 3 with bleeding);Grade 3 or 4 treatment-related non-hematological toxicity (Grade 3 nausea, vomiting or diarrhea that last \> 72 hours despite maximal treatment constitutes a DLT, insufficient treatment will not constitute an exception to the DLT criteria, as this would constitute inadequate conduct of the study); Dosing delay greater than 2 weeks due to treatment-emergent AEs or related severe laboratory abnormalities.

Once the MTD has been determined this will be the dose going forward in phase 2 studies

Plasma concentration data will be used to determine the following PK parameters:

* AUC Area under the concentration curve
* Cmax Maximum plasma concentration
* Tmax Time to maximum plasma concentration
* t1/2 Terminal phase half life
* CL/F Total body clearance
* Vd/F Apparent volume of distribution

Objective measurements of tumor size will be recorded from PET, CT scan and other measures.

As part of exploratory PD, the following assessments will be performed:

* Biomarkers including CA19-9 (or CA125, CEA if non-secretors for pancreas cancer), CEA and CA125 as applicable, any tumor marker appropriate to the given cancer or that is known to be elevated in a given patient will be evaluated according the Investigator's discretion, prior to every Cycle.
* Serum HSP70 levels
* PET Scans
* Evaluation of CT scans using Choi criteria

Minneamrita Therapeutics LLC

Symptoms and General Pathology

Gland and Hormone Related Diseases

Neoplasm Metastasis

Endocrine Gland Neoplasms

Neoplasms, Second Primary

Neoplastic Processes

Endocrine System Diseases

Anti-Infective Agents

Doxorubicin

Liposomal doxorubicin

Everolimus

Ethiodized Oil

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Sirolimus

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Immunosuppressive Agents

Immunologic Factors

After 2 sessions of embolization with microsphere of 100 to 500 µm or chemoembolization with 100 mg of doxorubicine and 10 ml of lipiodol, administered every day, 10 mg of everolimus during 24 months or until progression (hepatic and other site).

10 mg per day of everolimus during 24 months or until progression disease

2 sessions embolization with spheric particles

embolization

2 sessions chemoembolization with 10 mg of lipiodol with 100 mg of doxorubicine

Thomas WALTER, PhD

Determine wether 24 months treatment with everolimus prolongs progression free survival rate (based on a central assessment) after embolisation ou chemoembolisation for liver metastases.

* H0 a 24 months progression free survival rate less than 35% is unacceptable
* H1 a 24 months progression free survival rate greater than 35% would show that everolimus treatment is beneficial, the expected 24 months progression free survival rate being 50%

Everolimus After (Chemo)Embolization for Liver Metastases From Digestive Endocrine Tumors

Everolimus as Treatment After Embolization or Chemoembolization for Liver Metastases From Digestive Endocrine Tumors

Hepatic progression free survival rate as defined in RECIST 1.1 (with death considered as progression) during the 24 months of treatment with everolimus (appendix 3).

Progression-free survival rate (PFS) (based on the central assessment) according to RECIST v1.1 according to RECIST v1.1 will be defined as the time from the date of inclusion to the date of hepatic progression or death (due to any cause). For patients who are alive with no hepatic progression, it will be defines as the time from the date of inclusion and the date of the last tumor assessment.

Progression-free survival rate will be defined as the time from the date of inclusion to the date of disease progression (hepatic or not) evaluated by RECIST V1.1 criteria or death (due to any cause) or the date of the last morphological evaluation for patients who are alive with no disease progression.

Overall survival rate shall be defined as the time from the date of inclusion to the date of death, regardless of the cause of death, or the date of last contact for patients who are alive.

the toxicities recorded at each monthly visit, described using -CTCAE version 4.0; grade 3 and 4 toxicities will be reviewed;

Federation Francophone de Cancerologie Digestive

Skin and Connective Tissue Diseases

Gastrointestinal Stromal Tumors

Soft Tissue Neoplasms

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Mona-Elisabeth Revheim, MD

Therese Seierstad, PhD

Øyvind S Bruland, Prof., MD

Knut Håkon Hole, MD

Lars Julsrud, MD

The purpose of this study is to compare sensitivity, specificity and accuracy of PET, DW MRI and CT separately and combined for the evaluation of treatment response and progression-free survival in patients with GIST.

Treatment Response Evaluation in Gastrointestinal Stromal Tumor (GIST) Patients

Treatment Response Evaluation in Patients With Gastrointestinal Stromal Tumor Using PET/CT and DW MRI

Oslo University Hospital

Nuclear Medicine Phycisian

Nutritional and Metabolic Diseases

Body Weight

Anorexia

Weight Loss

Wasting Syndrome

Cachexia

Body Weight Changes

Acupuncture-A group will receive acupuncture in a pre-determined set of the acupuncture points that are selected based on the potential mechanisms of cachexia. Intervention will be done by a licensed acupuncturist who has over 5 years of experience as an independent clinician and has experience particularly in the management of cancer related symptoms. Acupuncture treatment will consist of 8 sessions over 8 week period.

Acupuncture needles: Single-use, sterile stainless steel and disposable \[acupuncture needles-Peace Classic Needles®, Acu-Market\] Other name: Mechanism based acupuncture

General Acupuncture-B group will receive acupuncture in a pre-determined set of the acupuncture points. These points are the real acupuncture points; however, these points are not specific to cachexia management. Participants will receive the acupuncture treatment over 8 weeks (total of 8 sessions) in the same manner as the experimental group; the only difference will be the place(type) and number of points targeted.

Acupuncture needles: single-use, sterile stainless steel and disposable needles \[Peace Classic Needles®, Acu-Market\] Other name: General acupuncture

Acupuncture-A group will receive acupuncture in a pre-determined set of the acupuncture points.

Cachexia Acupuncture-A (Peace Classic Needles® )

Acupuncture-B group will receive acupuncture in a pre-determined set of the acupuncture points.

General Acupuncture-B (Peace Classic Needles®)

Saunjoo Yoon, PhD

Patients with cancer often experience appetite loss and weight loss unintentionally. Rapid weight loss negatively impact on physical functioning, quality of life, and overall survival. Patients will be randomly assigned into two groups. An intervention with acupuncture may slow down or stop the progression of cancer-related anorexia and weight loss.

The purpose of this research study is to investigate if acupuncture helps to improve appetite and slow down unintentional weight loss. The participants will be randomly divided into two groups and receive 8 sessions of acupuncture (two groups will receive different acupuncture points) for 8 weeks. During the study period, participants will be asked various questions about appetite, physical functioning, cancer-related symptoms and quality of life to understand changes related to body weight, as well as blood samples. The research team members will collect data regarding changes in appetite, body weight, body composition, and physical functioning.

Acupuncture for Unintentional Weight Loss and Anorexia With GI Cancer

Impact of Mechanism Based Acupuncture Intervention to Improve Weight Loss in GI Cancer Patients With Cachexia

Survey format includes the 27 items (5 points scale: 0 means 'not at all' and 4 means 'very much") .

Survey format: 13 areas related to the symptom experience and patient's concerns will be assessed (4 points scale; 0 means 'not at all' and 3 means 'very much').

Weight will be measured each visit (pounds).

Three different short survey forms will be used to measure appetite change. Visual analogue scale (0 indicates no appetite and 10 is the best appetite). Simplified Nutritional Appetite Questionnaire score (min-max: 4-20 and the higher the better appetite) Patient Generated Subjective Global Assessment: 0-1, no intervention is needed. 9 or higher score indicates critical intervention.

survey form (min-max: 0-100, increment by 10%- 100% indicates full functioning).

Small, non-invasive device (bioelectrical impedance analysis) like a miniature version of EKG will measure changes in body composition (numeric scale).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
Study of Minnelide™ in Patients With Advanced GI Tumors	NCT01927965	Advanced Gastro...	Minnelide™ 001	18 Years -	Minneamrita Therapeutics LLC
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
Everolimus After (Chemo)Embolization for Liver Metastases From Digestive Endocrine Tumors	NCT01678664	Neuroendocrine ... Hepatic Metasta... Metastases	Everolimus embolization Doxorubicin	18 Years -	Federation Francophone de Cancerologie Digestive
Treatment Response Evaluation in Gastrointestinal Stromal Tumor (GIST) Patients	NCT01276483	Soft Tissue Neo... Gastrointestina...		-	Oslo University Hospital
Acupuncture for Unintentional Weight Loss and Anorexia With GI Cancer	NCT02148159	Malignant Neopl...	Cachexia Acupun... General Acupunc...	21 Years -	University of Florida

Spots Global Cancer Trial Database for gastrointestinal tract