Neoplasms

All Conditions

Digestive System Diseases

Symptoms and General Pathology

Rare Diseases

Carcinoma

Esophageal Neoplasms

Adenocarcinoma

Recurrence

Carcinoma in Situ

Barrett Esophagus

Precancerous Conditions

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Patients receive HPPH IV over 1 hour on day 1. Approximately 24 hours later, the lesion is exposed to laser light endoscopically.

Patients receive HPPH as in arm I, but at a higher dose, followed by laser light exposure.

HPPH

Hector R. Nava, MD, FACS

RATIONALE: Photodynamic therapy uses a drug, such as HPPH, that is absorbed by tumor cells. The drug becomes active when it is exposed to light, and kills tumor cells. HPPH may be effective in killing precancerous cells and tumor cells.

PURPOSE: This randomized phase II trial is studying how well photodynamic therapy with HPPH works in treating patients with precancerous esophageal conditions or stage 0 or stage I esophageal cancer.

OBJECTIVES:

* Determine response in patients with high-grade dysplasia, carcinoma in situ, or early intramucosal adenocarcinoma of the esophagus and Barrett's esophagus treated with photodynamic therapy using HPPH.
* Determine the safety, in terms of toxicity to surrounding normal tissue, of this regimen in these patients.
* Determine the toxic effects of this regimen on surrounding normal tissue in these patients.
* Determine the incidence of adenocarcinoma in these patients after this treatment.
* Determine the magnitude and duration of increased skin sun sensitivity in patients treated with this regimen.
* Determine the minimal erythemal dose of this regimen in these patients.

OUTLINE: This is a randomized study. Patients are stratified according to presence of intramucosal tumor (yes vs no). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive HPPH IV over 1 hour on day 1. Approximately 24 hours later, the lesion is exposed to laser light endoscopically.
* Arm II: Patients receive HPPH as in arm I, but at a higher dose, followed by laser light exposure.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 60 patients (30 per treatment arm) will be accrued for this study within 3 years.

Photodynamic Therapy in Treating Patients With Precancerous Esophageal Conditions or Early Stage Esophageal Cancer

A Phase II Study of HPPH Photodynamic Therapy for Treatment of High Grade Dysplasia, Carcinoma In-Situ or Early Intramucosal Adenocarcinoma in Barrett's Esophagus. Randomization to Two PDT Treatment Regimens of HPPH (2-1 [Hexyloxyethyl]-2devinylpyropheophorbide-a) and Light

Roswell Park Cancer Institute

Carcinoma, Squamous Cell

Esophageal Squamous Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Fluorouracil

Albumin-Bound Paclitaxel

Cisplatin

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

cisplatin

fluorouracil

paclitaxel

conventional surgery

neoadjuvant therapy

radiation therapy

Jonathan Cheng, MD

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with or without radiation therapy in treating patients who have esophageal cancer.

OBJECTIVES:

* Determine the median and two-year disease-free and overall survival of patients with resectable esophageal cancer treated with neoadjuvant paclitaxel, cisplatin, and fluorouracil with concurrent radiotherapy.
* Determine the complete and partial responses in patients treated with this regimen.
* Assess the toxicity of this regimen in these patients.
* Determine the optimal dose of paclitaxel when administered in this regimen in these patients.
* Determine the effect of tumor tubulin isoform expression on chemosensitivity and overall survival of patients treated with this regimen.

OUTLINE: Patients receive paclitaxel IV over 3 hours and cisplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for 2 courses.

Beginning 3 weeks after completion of initial chemotherapy, patients receive concurrent chemoradiotherapy comprising paclitaxel IV over 1 hour and cisplatin IV over 1 hour on days 1, 8, 15, 22, and 29; fluorouracil IV continuously for 5 weeks; and radiotherapy daily 5 days a week for 5 weeks.

At 4-8 weeks after completion of chemoradiotherapy, patients may undergo surgical resection. Patients with local progressive disease after 2 courses of initial chemotherapy undergo surgical resection instead of receiving concurrent chemoradiotherapy.

Patients are followed within 6 weeks, every 3 months for 3 years, and then annually for 2 years.

PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study.

Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Esophageal Cancer

Phase II Evaluation Of Paclitaxel, Cisplatin And 5-Fluorouracil Given In Combination With Radiation Therapy Prior To Surgery In Patients With Resectable Esophageal Cancer

National Cancer Institute (NCI)

Fox Chase Cancer Center

Dermatologic Agents

Central Nervous System Depressants

Dihematoporphyrin Ether

Trioxsalen

Ether

Photosensitizing Agents

porfimer sodium

RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. This may be an effective treatment for esophageal cancer.

PURPOSE: Phase II trial to study the effectiveness of photodynamic therapy in treating patients with Barrett's esophagus who have in situ esophageal cancer.

OBJECTIVES: I. Evaluate the efficacy of photodynamic therapy (PDT) using porfimer sodium (Photofrin) and controlled uniform laser light in patients with carcinoma in situ in Barrett's esophagus or severe dysplasia in Barrett's esophagus. II. Evaluate the safety of the treatment on this patient.

OUTLINE: This is a noncomparative study. PDT consists of IV porfimer sodium followed 40-50 hours later by laser red light delivered by optic fibers passed through the biopsy channel of an endoscope. Retreatment, if necessary, consists of up to 3 injections at least 30 days apart and up to 6 laser light treatments, with a maximum of 2 following each injection. Patients are followed monthly for 4 months, and then periodically for at least 5 years.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Photodynamic Therapy in Treating Patients With Early Esophageal Cancer

A Phase II Study of the Safety and Efficacy of Photodynamic Therapy in Carcinoma in Situ of the Esophagus

David C. Christiani, MD

RATIONALE: Gathering information about genes, cigarette smoking, and diet may help doctors learn more about risk factors that may cause esophageal cancer.

PURPOSE: This clinical trial is studying genetic and environmental risk factors related to esophageal cancer.

OBJECTIVES:

* Examine the role of several genetically-determined factors in combination with cigarette smoking and diet in the etiology and prevention of esophageal cancer.
* Identify polymorphisms in metabolizing enzymes (e.g., phase I or II metabolism \[GSTM1, GSTT1,CYP1A1, CYP3A5, mEH, NQO1, GSTP1\], DNA repair \[XRCC1, ERCC2\], free-radical formation \[MPO, MnSOD\], inflammatory genes \[ IL1-beta\], metastatic potential \[MMP1\], and cell cycle or tumor suppression \[p21, p53\]) and related path genes of susceptibility for esophageal cancer.

OUTLINE: Blood and tumor tissue samples are collected. DNA purified from these samples is analyzed using DNA-based assays to determine polymorphisms in various related gene pathways.

Patients complete questionnaires concerning environmental, smoking and diet habits.

PROJECTED ACCRUAL: A total of 1,000 tissue samples from patients and healthy participants (750 patients and 250 healthy participants) will be accrued for this study.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Photodynamic Therapy in Treating Patients With Precancerous Esophageal Conditions or Early Stage Esophageal Cancer	NCT00281736	Esophageal Canc... Precancerous Co...	HPPH	18 Years -	Roswell Park Cancer Institute
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Esophageal Cancer	NCT00021320	Esophageal Canc...	cisplatin fluorouracil paclitaxel conventional su... neoadjuvant the... radiation thera...	18 Years -	Fox Chase Cancer Center
Photodynamic Therapy in Treating Patients With Early Esophageal Cancer	NCT00002935	Esophageal Canc...	porfimer sodium	18 Years -	Roswell Park Cancer Institute
Photodynamic Therapy in Treating Patients With Early Esophageal Cancer	NCT00002935	Esophageal Canc...	porfimer sodium	18 Years -	Roswell Park Cancer Institute
Photodynamic Therapy in Treating Patients With Precancerous Esophageal Conditions or Early Stage Esophageal Cancer	NCT00281736	Esophageal Canc... Precancerous Co...	HPPH	18 Years -	Roswell Park Cancer Institute
Genetic and Environmental Risk Factors Related to Esophageal Cancer	NCT01035398	Esophageal Canc...		18 Years - 100 Years	Massachusetts General Hospital

Spots Global Cancer Trial Database for stage 0 esophageal cancer