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Prevention of Tumor Recurrence Following Surgical Resection (Phase Ii)Award last edited on: 2/5/13
Sponsored Program
SBIRAwarding Agency
NIH : NCITotal Award Amount
$1,754,278Award Phase
2Solicitation Topic Code
-----Principal Investigator
Jesse B WolinskyCompany Information
Phase I
Contract Number: 1R43CA135967-01Start Date: 9/1/08 Completed: 8/31/10
Phase I year
2008Phase I Amount
$255,800Public Health Relevance:
In 2007, lung cancer will be the number one cancer killer in the US with the identification of an estimated 213,380 new lung cancer cases. Roughly one-quarter of these patients will be considered candidates for potentially curative surgical resection. The extent of tissue removed during surgical resection of the tumor is minimized to preserve as much lung function as possible and reduce morbidity. Unfortunately, local recurrence following limited resection is significantly increased, and doubles to 16% even in patients with early stage lung cancer. While radiation and chemotherapy are commonly utilized as adjuvant therapies for more advanced primary cancers, use as a preventative therapy to decrease recurrence is administered only in selected cases. This is a consequence of the often severe side-effects associated with these treatments and the inability to accurately predict in which patients the benefits would warrant the additional morbidity. We are developing a drug delivery device that can be fixated along resection margins for the prevention of local recurrence. The ability to inhibit recurrence of malignant disease through local delivery while minimizing systemic exposure to toxic anticancer agents will ultimately lead to the first standard of care for prevention of recurrence in early stage lung cancer patients.
Public Health Relevance:
This Public Health Relevance is not available.
Thesaurus Terms:
There Are No Thesaurus Terms On File For This Project.
Phase II
Contract Number: 2R44CA135967-02A1Start Date: 9/1/08 Completed: 8/31/13
Phase II year
2011(last award dollars: 2012)
Phase II Amount
$1,498,478Public Health Relevance:
Fifth Base has developed a unique, and simple to use, drug-eluting implant that reduces the incidence of locoregional lung cancer recurrence by locally delivering therapeutic levels of drug to the site of disease for over several months. Locoregional tumor recurrence after a surgical lung resection is a significant clinical problem in the management of early stage lung cancer patients. Our device will be implanted at the time of surgery using standard procedures and surgical tools and enables a new paradigm of low toxicity, preventative treatment at the site of highest risk of tumor recurrence.
Thesaurus Terms:
Abscission;Achievement;Achievement Attainment;Adverse Effects;Animal Model;Animal Models And Related Studies;Animals;Anti-Cancer Agents;Antineoplastic Agents;Antineoplastic Drugs;Antineoplastics;Anzatax;Asotax;Biodistribution;Biologic Preservation;Biological Preservation;Body Tissues;Bristaxol;Coad;Copd;Cancer Drug;Cancer Patient;Cancers;Canine Species;Canis Familiaris;Case Study;Characteristics;Chemistry;Chronic;Chronic Obstructive Airway Disease;Chronic Obstructive Lung Disease;Chronic Obstructive Pulmonary Disease;Clinical;Clinical Trials;Cyclic Gmp;Data;Definitive Radiation Therapy;Development;Devices;Disease;Disease By Site;Disorder;Disorder By Site;Dogs;Dogs Mammals;Drug Design;Drug Kinetics;Drug Usage;Drugs;Ebrt;Emphysema;Equilibrium;Evaluation;Excision;Excretory Function;External Beam Rt;External Beam Radiation Therapy;External Radiation;Extirpation;Fibrosis;Goals;Guanosine Cyclic 3',5'-Monophosphate;Guanosine Cyclic Monophosphate;Guanosine, Cyclic 3',5'-(Hydrogen Phosphate);Human;Irbs;Implant;In Vitro;Incidence;Institutional Review Boards;Investigation;Label;Lead;Lobectomy;Lung;Lung Neoplasms;Lung Respiratory System;Lung Tumor;Malignant;Malignant - Descriptor;Malignant Neoplasms;Malignant Tumor;Malignant Tumor Of The Lung;Malignant Neoplasm Of Lung;Man (Taxonomy);Medication;Microscopic;Modeling;Modern Man;Morbidity;Morbidity - Disease Rate;Neoplastic Disease Chemotherapeutic Agents;Operative Procedures;Operative Surgical Procedures;Outcome;Paclitaxel;Paclitaxel (Taxol);Palliative Care;Palliative Therapy;Palliative Treatment;Patients;Pb Element;Performance;Pharmaceutic Preparations;Pharmaceutical Preparations;Pharmacokinetics;Phase;Polymers;Praxel;Prevention;Procedures;Process;Pulmonary Cancer;Pulmonary Emphysema;Pulmonary Neoplasms;Pulmonary Malignant Neoplasm;Qol;Quality Control;Quality Of Life;Radiation Therapy;Radiotherapeutics;Radiotherapy;Recurrence;Recurrent;Recurrent Neoplasm;Recurrent Tumor;Removal;Resected;Residual;Residual Tumors;Residual State;Respiratory Physiology;Risk;Sbir;Sbirs (R43/44);Safety;Site;Small Business Innovation Research;Small Business Innovation Research Grant;Solubility;Staging;Surgeon;Surgical;Surgical Interventions;Surgical Procedure;Surgical Removal;Taxol;Taxol (Old Nsc);Taxol A;Taxol Konzentrat;Techniques;Technology;Testing;Therapeutic;Time;Tissues;Toxic Effect;Toxicities;Toxicity Testing;Toxicity Tests;Treatment Side Effects;Tumor Burden;Tumor Cell;Tumor Load;Tumor-Specific Treatment Agents;Validation;Work;Anticancer Agent;Anticancer Drug;Aqueous;Balance;Balance Function;Base;Biocompatibility;Biomaterial Compatibility;Cgmp;Cancer Recurrence;Canine;Case Report;Chemotherapy;Clinical Investigation;Clinical Research Site;Clinical Site;Comfort Care;Commercialization;Controlled Release;Copolymer;Developmental;Disease Recurrence Prevention;Disease/Disorder;Disorder Later Incidence Prevention;Disorder Recurrence Prevention;Domestic Dog;Drug Use;Drug/Agent;Excretion;External-Beam Radiation;Guanosine 3'5'monophosphate;Heavy Metal Pb;Heavy Metal Lead;High Risk;Implantation;In Vivo;Lung Cancer;Lung Function;Malignancy;Model Organism;Monomer;Neoplasm Recurrence;Neoplasm/Cancer;Neoplastic;Neoplastic Cell;Palliative Chemotherapy;Preclinical Safety;Preclinical Toxicity;Preservation;Prevent;Preventing;Pulmonary;Pulmonary Function;Recurrence Prevention;Relapse Prevention;Resection;Residual Disease;Respiratory Function;Response;Safety Study;Scale Up;Side Effect;Standard Of Care;Surgery;Therapy Adverse Effect;Tool;Treatment Adverse Effect;Tumor