Neoplasms

All Conditions

Head and Neck Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Cetuximab

TNFerade biologic

Everett Vokes,, MD

This study is looking at the safety and tolerability of TNFeradeä Biologic combined with conventional once daily radiation therapy in elderly or frail patients with new onset locally advanced head and neck tumors.

Radiotherapy, Cetuximab, and Injections of TNFerade™ Biologic for Elderly or Frail Patients With Head and Neck Cancer

A Phase I/II Safety, Tolerability and "Proof of Concept" Study of Radiotherapy, Cetuximab, and Intratumoral Injections of TNFerade™ Biologic (AdGVEGR.TNF.11D) for Elderly or Frail Patients or Intermediate Stage Patients With Head and Neck Cancer

GenVec

Paul Fischer, PhD

Symptoms and General Pathology

Recurrence

Antisickling Agents

Fluorouracil

Hydroxyurea

Everett Vokes, MD

The primary objective of the first phase is to determine the safety, the maximum tolerated dose (MTD) and dose-limiting toxicity of TNFerade in combination with the previously studied combination of Fluorouracil (5FU), Hydroxyurea (HU) and standard daily radiotherapy in patients with recurrent head and neck cancer (RHNC). All chemoradiotherapy is administered on a "week-on/week-off" schedule. The primary objective of the second phase II is to determine the locoregional control rate at 24 months.

A Study of TNFerade™ Biologic With Concomitant Radiotherapy, Fluorouracil, and Hydroxyurea (TNF-FHX) in Patients With Head and Neck Cancer

A Phase I/II Safety, Tolerability, and "Proof of Concept" Study of TNFerade™ Biologic in Combination With Concomitant Radiotherapy, Fluorouracil, and Hydroxyurea (TNF-FHX) for Patients With Unresectable Recurrent Head and Neck Cancer

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Androgens

TNFerade™ Biologic

Beth Manchen

While radiation therapy with androgen ablation (hormone reduction) is the standard method of treating locally advanced prostate cancer. New treatments are being combined with radiation therapy in an effort to further improve the cure rates.

This study proposes to combine an experimental drug, TNFerade™ Biologic, (also called AdGVEGR.TNF.11D or "TNFerade") at different dose (amounts) levels in combination with radiation.

TNFerade™ Biologic is a form of gene transfer therapy that when injected into the tumor has shown to increase the effect of radiation therapy.

TNFerade Biologic to Treat Locally Advanced Prostate Cancer

A PHASE I SAFETY AND TOLERABILITY TRIAL OF RADIOTHERAPY, ANDROGEN DEPRIVATION, AND INTRATUMORAL INJECTIONS OF AdGVEGR.TNF.11D (TNFeradeTM) FOR PATIENTS WITH LOCALLY ADVANCED PROSTATE CANCER

National Institutes of Health (NIH)

Paul Fischer, PhD, CEO

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Radiotherapy, Cetuximab, and Injections of TNFerade™ Biologic for Elderly or Frail Patients With Head and Neck Cancer	NCT00496236	Head and Neck C... Head and Neck N...	TNFerade biolog...	18 Years -	GenVec
Radiotherapy, Cetuximab, and Injections of TNFerade™ Biologic for Elderly or Frail Patients With Head and Neck Cancer	NCT00496236	Head and Neck C... Head and Neck N...	TNFerade biolog...	18 Years -	GenVec
A Study of TNFerade™ Biologic With Concomitant Radiotherapy, Fluorouracil, and Hydroxyurea (TNF-FHX) in Patients With Head and Neck Cancer	NCT00496535	Head and Neck C... Head and Neck N...	TNFerade biolog...	18 Years -	GenVec
TNFerade Biologic to Treat Locally Advanced Prostate Cancer	NCT01048151	Locally Advance...	TNFerade™ Biolo...	-	GenVec

Spots Global Cancer Trial Database for tnferade biologic