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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | October 11, 2001 | ||||
| Last Updated Date | July 23, 2008 | ||||
| Start Date ICMJE | June 2001 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00025571 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Photodynamic Therapy With HPPH in Treating Patients With Non-Small Cell Lung Cancer | ||||
| Official Title ICMJE | A Phase I Study of Photodynamic Therapy (PDT) Using 2-(1-Hexyloxyethyl)-2 Devinyl Pyropheophorbide-a (HPPH) for Treatment of Early Stage Lung Cancer - A Dose Ranging Study | ||||
| Brief Summary | 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 non-small cell lung cancer. |
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| Detailed Description | OBJECTIVES:
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. |
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| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE | Lung Cancer | ||||
| Intervention ICMJE | Drug: HPPH | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00025571 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000068974, RPCI-RP-0005, NCI-G01-2023 | ||||
| Study Sponsor ICMJE | Roswell Park Cancer Institute | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | July 2002 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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