Neoplasms

All Conditions

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Rare Diseases

Carcinoma

Neoplasm Metastasis

Breast Neoplasms

Carcinoma, Ductal

Carcinoma in Situ

Carcinoma, Lobular

Breast Carcinoma In Situ

Carcinoma, Intraductal, Noninfiltrating

Carcinoma, Ductal, Breast

Breast Diseases

Paget's Disease, Mammary

Skin Diseases

Neoplastic Processes

Paget Disease of the Breast

adjuvant therapy

conventional surgery

3-dimensional conformal radiation therapy

brachytherapy

intracavitary balloon brachytherapy

proton beam radiation therapy

Lilie Lin, MD

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells.

PURPOSE: This clinical trial is studying the side effects of partial breast radiation therapy and how well it works in treating women undergoing breast conservation therapy for early-stage breast cancer.

OBJECTIVES:

* To allow women undergoing breast conservation therapy for early-stage breast cancer to have access to accelerated partial breast irradiation therapy on a controlled trial.
* To capture prospective data on acute and late toxicity and disease recurrence in patients treated with this therapy.
* To summarize the institutional experience of these patients treated with this experimental therapy.

OUTLINE: Within 9 weeks after surgery, patients undergo accelerated partial breast irradiation (including conformal external-beam irradiation, interstitial brachytherapy, intracavitary brachytherapy, or proton beam irradiation) twice daily for 5 days (10 fractions).

After completion of study therapy, patients are followed every 3 to 6 months for at least 5 years and then annually thereafter.

Partial Breast Radiation Therapy in Treating Women Undergoing Breast Conservation Therapy for Early-Stage Breast Cancer

Accelerated Partial Breast Irradiation

National Cancer Institute (NCI)

Abramson Cancer Center at Penn Medicine

Digestive System Diseases

Gland and Hormone Related Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Infections

Recurrence

Cholangiocarcinoma

Adenocarcinoma

Pancreatic Neoplasms

Thyroid Diseases

Stomach Neoplasms

Head and Neck Neoplasms

Carcinoma, Hepatocellular

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Liver Neoplasms

Breast Neoplasms, Male

Testicular Neoplasms

Carcinoma, Medullary

Fowlpox

Neoplasms, Germ Cell and Embryonal

Gallbladder Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Stomach Diseases

Liver Diseases

Neoplasms by Histologic Type

Biliary Tract Neoplasms

Biliary Tract Diseases

Gallbladder Diseases

Pancreatic Cancer

Ovarian Cancer

Bile Duct Cancer

Stomach Cancer

Ovarian Epithelial Cancer

Primary Liver Cancer

Gallbladder Cancer

Breast Cancer, Male

Germ Cells Tumors

Thyroid Cancer, Medullary

Testicular Germ Cell Tumor

All Drugs and Chemicals

Anti-Infective Agents

Hematinics

Gastrointestinal Agents

Herbal and Botanical

Vaccines

Metronidazole

Immunomodulating Agents

Liver Extracts

Pancrelipase

Pancreatin

Anti-Bacterial Agents

Antiprotozoal Agents

Antiparasitic Agents

Cola

dendritic cells loaded with TRICOM-CEA(6D)

TRICOM-CEA(6D)

Herbert K. Lyerly, MD

RATIONALE: Vaccines made from a person's white blood cells that have been treated in the laboratory may make the body build an immune response to kill tumor cells.

PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have advanced or metastatic cancer.

OBJECTIVES:

* Determine the safety and feasibility of active immunotherapy comprising autologous dendritic cells infected with recombinant fowlpox-CEA-TRICOM vaccine in patients with advanced or metastatic malignancies expressing CEA.
* Assess the CEA-specific immune response of patients treated with this regimen.
* Assess, in a preliminary manner, the clinical response rate of patients treated with this regimen.

OUTLINE: This is a dose-escalation study.

Autologous dendritic cells (ADCs) are harvested and infected with fowlpox-CEA-TRICOM vaccine. Patients receive the infected ADCs intradermally and subcutaneously (SC) followed by ADCs mixed with CMV pp65 peptide and ADCs mixed with tetanus toxoid SC and intradermally on day 1. Treatment repeats every 3 weeks for a total of 4, 8, or 12 immunizations in the absence of unacceptable toxicity.

Cohorts of 6 patients receive an escalating number of immunizations until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 6-18 patients will be accrued for this study.

Vaccine Therapy in Treating Patients With Advanced or Metastatic Cancer

A Phase I Study Of Active Immunotherapy With Autologous Dendritic Cells Infected With CEA-6D Expressing Fowlpox -Tricom In Patients With Advanced Or Metastatic Malignancies Expressing CEA

The primary objective of this protocol is to determine the safety and feasibility of rF-CEA(6D)-TRICOM loaded DC in, subjects with metastatic, CEA expressing malignancies.

The immune response to the injections of the TRICOM-CEA(6D) antigen loaded DC will be evaluated

Michael Morse, MD

Principal Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Partial Breast Radiation Therapy in Treating Women Undergoing Breast Conservation Therapy for Early-Stage Breast Cancer	NCT00599989	Breast Cancer Long-term Effec... Skin Reactions ...	adjuvant therap... conventional su... 3-dimensional c... brachytherapy intracavitary b... proton beam rad...	18 Years - 120 Years	Abramson Cancer Center at Penn Medicine
Vaccine Therapy in Treating Patients With Advanced or Metastatic Cancer	NCT00027534	Breast Cancer Colorectal Canc... Gallbladder Can... Gastric Cancer Head and Neck C... Liver Cancer Ovarian Cancer Pancreatic Canc... Testicular Germ...	TRICOM-CEA(6D)	18 Years -	Duke University
Partial Breast Radiation Therapy in Treating Women Undergoing Breast Conservation Therapy for Early-Stage Breast Cancer	NCT00599989	Breast Cancer Long-term Effec... Skin Reactions ...	adjuvant therap... conventional su... 3-dimensional c... brachytherapy intracavitary b... proton beam rad...	18 Years - 120 Years	Abramson Cancer Center at Penn Medicine

Spots Global Cancer Trial Database for paget disease of the breast with intraductal carcinoma