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Photodynamic Therapy Using HPPH in Treating Patients With Obstructive Esophageal Tumors Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Photodynamic Therapy Using HPPH in Treating Patients With Obstructive Esophageal Tumors conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Photodynamic Therapy Using HPPH in Treating Patients With Obstructive Esophageal Tumors Clinical research trials and Photodynamic Therapy Using HPPH in Treating Patients With Obstructive Esophageal Tumors healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Photodynamic Therapy Using HPPH in Treating Patients With Obstructive Esophageal Tumors. Photodynamic Therapy Using HPPH in Treating Patients With Obstructive Esophageal Tumors Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Photodynamic Therapy Using HPPH in Treating Patients With Obstructive Esophageal Tumors clinical trial. Participants typically obtain the most effective healthcare available for their Photodynamic Therapy Using HPPH in Treating Patients With Obstructive Esophageal Tumors condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Photodynamic Therapy Using HPPH in Treating Patients With Obstructive Esophageal Tumors  Photodynamic Therapy Using HPPH in Treating Patients With Obstructive Esophageal Tumors
Photodynamic Therapy Using HPPH in Treating Patients With Obstructive Esophageal Tumors
For Condition: stage 4 esophageal cancer,stage 1 esophageal cancer,stage 2 esophageal cancer,recurrent esophageal cancer,stage 3 esophageal cancer
Status: No longer recruiting
Sponsor(s): Roswell Park Cancer Institute , National Cancer Institute (NCI)
Synopsis: RATIONALE: Photodynamic therapy uses light and drugs that make tumor cells more sensitive to light to kill tumor cells. Photosensitizing drugs such as HPPH are absorbed by tumor cells and, when exposed to light, become active and kill the tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of photodynamic therapy with HPPH in treating patients who have obstructive esophageal tumors.
Details: OBJECTIVES: - Determine, preliminarily, the safety of HPPH in patients with obstructive esophageal tumors undergoing photodynamic therapy. - Determine, preliminarily, tumor response in patients treated with this drug. - Determine the length of time for cutaneous photosensitivity at the various drug doses in these patients. - Determine plasma clearance rates for this drug in these patients. OUTLINE: This is a dose-escalation study. - Patients receive HPPH IV over 1 hour on day 1. Patients then undergo laser light therapy on day 2. Cohorts of 3 patients receive escalating doses of HPPH and a single light dose until the optimal dose is determined. The optimal dose is defined as the minimum dose producing efficacy without unacceptable toxicity. - Phase II: Patients receive treatment as in phase I at the optimal dose. Patients are followed monthly for 6-24 months. PROJECTED ACCRUAL: A total of 9-14 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed esophageal cancer - Stages T1-T3, any N, any M - Tumor partially or completely obstructing the esophagus - Primary or recurrent tumor meeting 1 of the following criteria for treatment: - Patient is too debilitated for or refused conventional therapy - Recurred after or failed to respond to chemotherapy, radiotherapy, or surgery - Deemed most appropriately treated by photodynamic therapy (PDT) in the opinion of the physician - Persistent symptomatic disease required in patients who received prior radiotherapy, chemotherapy, or PDT with photofrin or HPPH - Prior PDT with HPPH allowed only if tumor is evident outside of the original treatment site - No tracheal or bronchial involvement by bronchoscopy - No T4 lesions involving the aorta, lung, or pericardium by CT scan, MRI, or endoscopic ultrasonography PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Not specified Life expectancy - Not specified Hematopoietic - WBC at least 2,000/mm^3 - Platelet count at least 50,000/mm^3 Hepatic - Bilirubin no greater than 3.0 mg/dL - Alkaline phosphatase no greater than 3 times upper limit of normal (ULN) - SGOT no greater than 3 times ULN - PT no greater than 1.5 times ULN Renal - Creatinine no greater than 3.0 mg/dL Other - Not pregnant - Negative pregnancy test - Fertile patients must use effective contraception - No contraindications to endoscopy - No porphyria - No hypersensitivity to porphyrins PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics - More than 4 weeks since prior chemotherapy - No concurrent chemotherapy Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics - More than 4 weeks since prior radiotherapy - No concurrent radiotherapy Surgery - Not specified Other - No concurrent photosensitizing agents (e.g., tetracyclines, sulfonamides, phenothiazines, sulfonylureas, hypoglycemic agents, thiazide diuretics, and griseofulvin)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HectorNava, Study Chair, Roswell Park Cancer Institute
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Additional Information:
Study ID Numbers: CDR0000301589; RPCI-DS-9701
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00060268
Other Stage 2 Esophageal Cancer Studies:
1. PNU-93914 in Treating Patients With Locally Advanced or Metastatic Cancer of the Esophagus
2. Docetaxel Plus Carboplatin in Treating Patients With Advanced Cancer of the Esophagus
3. Photodynamic Therapy Using HPPH in Treating Patients With Obstructive Esophageal Tumors
4. Arsenic Trioxide in Treating Patients With Advanced Cancer of the Esophagus or Gastroesophageal Junction
5. Erlotinib in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer
Related Studies:
Other stage 2 esophageal cancer Clinical Trials
Other New York Clinical Trials
Other Buffalo Clinical Trials
Photodynamic Therapy Using HPPH in Treating Patients With Obstructive Esophageal Tumors
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