Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Digestive System Diseases

Nervous System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Breast Neoplasms

Melanoma

Head and Neck Neoplasms

Gastrointestinal Neoplasms

Central Nervous System Neoplasms

Thoracic Neoplasms

Urogenital Neoplasms

Digestive System Neoplasms

Skin Diseases

Breast Diseases

Gastrointestinal Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Patients will receive alisertib orally twice a day for the first 7 days of a 21 day cycle. Patients will also receive pazopanib orally once a day continuously. Treatment continues until disease progression, unacceptable toxicity or patient refusal. The study consists of two components which are the dose finding component and optimally tolerated dose extension with pharmacokinetics component.

Alisertib at the assigned dose by mouth (PO) twice a day for 7 days beginning on day 1 of a 21 day cycle.

Alisertib

Pazopanib at the assigned dose once a day continuously for the duration of treatment.

Pazopanib

Arkadiusz Z. Dudek, M.D.

This phase I trial using the EffTox design will evaluate activity and safety of alisertib, an Aurora A kinase inhibitor, when given in combination with the selective VEGFR inhibitor pazopanib in patients with advanced, previously treated non-hematologic solid tumors.

Phase I Study of MLN8237 and Pazopanib in Patients With Solid Tumors

STM-01: Phase I EffTox Study of Aurora A Kinase Inhibitor Alisertib (MLN8237) Given in Combination With Selective VEGFR Inhibitor Pazopanib (Votrient) for Therapy of Solid Tumors

Complete all planned treatment for cycle 1 (defined as 14 doses of alisertib and daily pazopanib) without dose limiting toxicity and are able to start cycle 2 with no more than a 2 week delay.

Adverse events which occur after taking at least one dose of study treatment with either alisertib and/or pazopanib.

Millennium Pharmaceuticals, Inc.

University of Illinois at Chicago

Professor

Symptoms and General Pathology

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	Link
Phase I Study of MLN8237 and Pazopanib in Patients With Solid Tumors	NCT01639911	Malignant Neopl... CNS Malignancy Malignant Neopl... Genitourinary N... Head and Neck N... Melanoma Malignant Neopl...	Alisertib Pazopanib	18 Years -	University of Illinois at Chicago
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 malignant neoplasm of gastrointestinal tract