Infections

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Influenza, Human

Virus Diseases

Communicable Diseases

Respiratory Tract Infections

Orthomyxoviridae Infections

RNA Virus Infections

Respiratory Tract Diseases

All Drugs and Chemicals

Vaccines

Immunologic Factors

Each subject will receive two doses of the assigned vaccine, the first on Study Day 1, and the second on Study Day 22

7.5 ug of HA antigen; adjuvanted; monovalent

adjuvanted A(H1N1) influenza vaccine

15ug of HA antigen, non-adjuvanted; trivalent

non-adjuvanted A(H1N1) influenza vaccine

15 mcg of antigen; non-adjuvanted; trivalent

This is a phase III, randomized, controlled, open label study with two vaccine regimens. The study will assess the relative safety and immunogenicity of vaccine regimens comparing adjuvanted versus non-adjuvanted formulations of A(H1N1) inactivated influenza virus vaccine in subjects with Solid Invasive Tumors and to compare safety and immunogenicity data with a contemporaneously enrolled control group of age-comparable, healthy subjects.

Because certain individuals may be hypo-responsive to influenza vaccination, additional studies with high-risk groups are warranted in order to determine the optimal vaccine formulation and dosing schedule for prevention of novel H1N1 virus infection.

Clinical Trial to Compare the Immunogenicity, Safety, and Tolerability of an Adjuvanted A(H1N1) Influenza Vaccine Versus Non-Adjuvanted A(H1N1) Influenza Vaccines in Patients With Invasive Solid Tumors

A Phase III, Randomized, Controlled, Open Label Study to Evaluate the Immunogenicity, Safety, and Tolerability of an Adjuvanted A(H1N1) Vaccine Versus Non-Adjuvanted Vaccines Against Novel H1N1 Virus in Patients With Invasive Solid Tumors

Chiltern Pesquisa Clinica Ltda

Antineoplastic Agents

Trastuzumab

Radiopharmaceuticals

Antineoplastic Agents, Immunological

Patients with advanced solid tumors that express HER2 with tumors that are HER2 1+ by IHC or FISH.

Pt will undergo one PET study following the i.v. administration of 10mCi of 68Ga-F(ab')2-trastuzumab fragments (HERScan). The PET study will be performed within 4 weeks of the patient's most recent imaging studies. A subset of 10 patients who have evidence of tumor uptake and localization with the 68Ga-F(ab')2-trastuzumab fragments will be asked to undergo follow-up PET scans (up to a maximum of 3) to examine the time course of HER-2 expression. These follow-up PET scans will be performed concurrently with the patient's standard imaging studies to evaluate response to their current therapy as per their treating physicians.

PET Imaging with Ga-68 Labeled F(ab') 2- Trastuzumab

Once safety and feasibility has been established in this group, then enrollment to the HER2 1+ cohort will commence. Pt will undergo one PET study following the i.v. administration of 10mCi of 68Ga-F(ab')2-trastuzumab fragments (HERScan). The PET study will be performed within 4 weeks of the patient's most recent imaging studies. A subset of 10 patients who have evidence of tumor uptake and localization with the 68Ga-F(ab')2-trastuzumab fragments will be asked to undergo follow-up PET scans (up to a maximum of 3) to examine the time course of HER-2 expression. These follow-up PET scans will be performed concurrently with the patient's standard imaging studies to evaluate response to their current therapy as per their treating physicians.

Jorge Carrasquillo, MD

The purpose of this study is to learn more about how a new study agent works inside the body. This study agent is a protein called 68Ga-F(ab')2-trastuzumab fragments (HERScan). This is a radioactive tracer that was developed at MSKCC to target the HER2 protein on cancer cells. By giving this tracer to patients whose cancers have the HER2 protein, we hope to be able to see the level of HER2 on the cancer cells using PET scanning.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Clinical Trial to Compare the Immunogenicity, Safety, and Tolerability of an Adjuvanted A(H1N1) Influenza Vaccine Versus Non-Adjuvanted A(H1N1) Influenza Vaccines in Patients With Invasive Solid Tumors	NCT01031719	H1N1 Influenza ... Invasive Solid ...	adjuvanted A(H1... non-adjuvanted ... non-adjuvanted ...	2 Years - 70 Years	Chiltern Pesquisa Clinica Ltda
Biodistribution and Dosimetry of Serial PET Imaging With Ga-68 Labeled F(ab') 2- Trastuzumab	NCT00613847	Solid Tumors	PET Imaging wit... PET Imaging wit...	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for invasive solid tumors