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Home > "P" Clinical Trials Conditions > Photodynamic Therapy With HPPH in Treating Patients With Early Stage Lung Cancer  Photodynamic Therapy With HPPH in Treating Patients With Early Stage Lung Cancer
Photodynamic Therapy With HPPH in Treating Patients With Early Stage Lung Cancer
For Condition: squamous cell lung cancer,stage 0 non-small cell lung cancer,adenocarcinoma of the lung,large cell lung cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Roswell Park Cancer Institute
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 trial to study the effectiveness of photodynamic therapy with HPPH in treating patients who have early stage lung cancer.
Details: OBJECTIVES: I. Determine the systemic and normal tissue toxicity of photodynamic therapy with HPPH in patients with early stage lung cancer. II. Determine, preliminarily, the efficacy of this regimen in these patients. PROTOCOL OUTLINE: This is a dose-escalation study of HPPH. Patients receive HPPH IV over 1 hour on day 1. Patients undergo laser light therapy via bronchoscopy on day 3. Cohorts of 3-6 patients receive escalating doses of HPPH until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed for at least 6 months. PROJECTED ACCRUAL: Approximately 15-17 patients will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically confirmed carcinoma in situ or microinvasive lung cancer - Squamous cell carcinoma - Adenocarcinoma - Large cell carcinoma No tumors that are more than microinvasive --Prior/Concurrent Therapy-- Biologic therapy: Prior biologic therapy for lung cancer allowed Chemotherapy: - At least 4 weeks since prior chemotherapy - No concurrent chemotherapy Endocrine therapy: Prior endocrine therapy for lung cancer allowed Radiotherapy: - At least 4 weeks since prior radiotherapy - No concurrent radiotherapy Surgery: Not specified Other: Prior therapy for lung cancer allowed --Patient Characteristics-- Age: 18 and over Performance status: Karnofsky 50-100% OR ECOG 0-2 Life expectancy: Not specified Hematopoietic: - WBC at least 2,000/mm3 - Platelet count at least 50,000/mm3 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 Pulmonary: No severe chronic obstructive pulmonary disease that would preclude study Other: - Not pregnant - Fertile patients must use effective contraception - No contraindications to bronchoscopy - No porphyria - No hypersensitivity to porphyrin or porphyrin-like compounds
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: CDR0000068974; RPCI-RP-0005,NCI-G01-2023
Study Start Date: June 2001
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00025571
Other Adenocarcinoma Of The Lung Studies:
1. Combination Chemotherapy, Gefitinib, and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer
2. Radiation Therapy to Relieve Symptoms in Patients With Non-small Cell Lung Cancer
3. Interleukin-2 Combined With Monoclonal Antibody Therapy in Treating Patients With Kidney, Bladder, or Lung Cancer That Has Not Responded to Previous Treatment
4. Paclitaxel With or Without Carboplatin in Treating Patients With Advanced Non-small Cell Lung Cancer
5. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Can Not Be Surgically Removed
Related Studies:
Other adenocarcinoma of the lung Clinical Trials
Other New York Clinical Trials
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Photodynamic Therapy With HPPH in Treating Patients With Early Stage Lung Cancer
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