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Photodynamic Therapy Plus Brachytherapy in Treating Patients With Lung Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Photodynamic Therapy Plus Brachytherapy in Treating Patients With Lung Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Photodynamic Therapy Plus Brachytherapy in Treating Patients With Lung Cancer Clinical research trials and Photodynamic Therapy Plus Brachytherapy in Treating Patients With Lung Cancer healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Photodynamic Therapy Plus Brachytherapy in Treating Patients With Lung Cancer. Photodynamic Therapy Plus Brachytherapy in Treating Patients With Lung Cancer Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Photodynamic Therapy Plus Brachytherapy in Treating Patients With Lung Cancer clinical trial. Human subjects often receive the most effective healthcare possible for their Photodynamic Therapy Plus Brachytherapy in Treating Patients With Lung Cancer condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Photodynamic Therapy Plus Brachytherapy in Treating Patients With Lung Cancer  Photodynamic Therapy Plus Brachytherapy in Treating Patients With Lung Cancer
Photodynamic Therapy Plus Brachytherapy in Treating Patients With Lung Cancer
For Condition: recurrent non-small cell lung cancer,Recurrent Small Cell Lung Cancer,limited stage small cell lung cancer,stage 1 non-small cell lung cancer,stage 0 non-small cell lung cancer
Status: Completed
Sponsor(s): Roswell Park Cancer Institute ,
Synopsis: RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. Brachytherapy uses radiation to damage tumor cells. Photodynamic therapy combined with brachytherapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of photodynamic therapy plus brachytherapy in treating patients with recurrent lung cancer that is blocking the lung passages.
Details: OBJECTIVES: I. Determine the feasibility, toxicity, and effectiveness of combination therapy with Photofrin PDT and HDT brachytherapy in patients with endobronchial obstructions from lung cancer. PROTOCOL OUTLINE: This is not a randomized study. Photofrin solution is administered slowly as a bolus injection over 3-5 minutes on day 1. Bronchoscopy is performed under general anesthesia 48 hours after Photofrin injection. Light is transmitted from the laser to the tumor via quartz fiber optics (interstitial or surface PDT). Another bronchoscopy is performed 48 hours after PDT treatment to clean out any tissue debris left after PDT treatment. HDR brachytherapy is performed using prescribed dose of radiation for 5-10 minutes to designated positions. Repeat bronchoscopy is performed 3-4 weeks post HDR brachytherapy and a second HDR brachytherapy treatment may be given. Patients are followed every 3 months until death, or for 5 years. PROJECTED ACCRUAL: 16 patients will be entered over 1.5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed small cell or non-small cell primary lung cancer with symptomatic endobronchial lesion(s) partially or totally obstructing airway distal to the carina and accessible by endoscopy - Recurrent disease following prior therapy and/or be ineligible for, or refuse, alternative standard therapy such as: Surgery; External radiation therapy; Chemotherapy - High grade obstruction necessitating more rapid aeration and palliation than standard therapy can provide - No evidence of encasement or extension of the tumor to the right or left major pulmonary vessels on CT of the chest - No tumor involvement at trachea or carina --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No chemotherapy within 3 weeks prior to study entry; No doxorubicin within 8 weeks prior to study entry - Endocrine therapy: Not specified - Radiotherapy: Prior radiation therapy dose no higher than 75 Gy to proposed bronchial segment allowed; No concurrent external brain radiation therapy - Surgery: Not specified --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: Not specified - Hematopoietic: WBC at least 4,000/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin less than 2 times the upper limit of normal; SGOT/SGPT less than 2 times the upper limit of normal - Renal: Creatinine no greater than 2.0 mg/dL - Other: Not pregnant; Adequate method of contraception required of all fertile patients; Female fertile patients must have normal serum beta HCG; Not eligible for standard therapy and/or other protocol therapy; No hypersensitivity to DHE or other porphyrins; Not concurrent photosensitizing drugs such as: Tetracycline, Doxorubicin; No contraindications to general anesthesia, including EKG abnormalities suggestive of acute ischemia
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GregoryLoewen, Study Chair, Roswell Park Cancer Institute
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Additional Information:
Study ID Numbers: CDR0000065448; RPCI-DS-92-40,NCI-V97-1190
Study Start Date: March 2001
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00014066
Other Stage 1 Non-Small Cell Lung Cancer Studies:
1. SGN-15 And Docetaxel in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
2. Gemcitabine Plus Docetaxel or Irinotecan in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
3. Arsenic Trioxide in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
4. Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer
5. Acridine Carboxamide in Treating Patients With Advanced Non-small Cell Lung Cancer
Related Studies:
Other stage 1 non-small cell lung cancer Clinical Trials
Other New York Clinical Trials
Other Buffalo Clinical Trials
Photodynamic Therapy Plus Brachytherapy in Treating Patients With Lung Cancer
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