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Photodynamic Therapy in Treating Patients With Stage III or Stage IV Melanoma Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Photodynamic Therapy in Treating Patients With Stage III or Stage IV Melanoma conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Photodynamic Therapy in Treating Patients With Stage III or Stage IV Melanoma Clinical research trials and Photodynamic Therapy in Treating Patients With Stage III or Stage IV Melanoma medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Photodynamic Therapy in Treating Patients With Stage III or Stage IV Melanoma. Photodynamic Therapy in Treating Patients With Stage III or Stage IV Melanoma Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Photodynamic Therapy in Treating Patients With Stage III or Stage IV Melanoma clinical trial. Subjects typically recieve the finest healthcare available for their Photodynamic Therapy in Treating Patients With Stage III or Stage IV Melanoma condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Photodynamic Therapy in Treating Patients With Stage III or Stage IV Melanoma  Photodynamic Therapy in Treating Patients With Stage III or Stage IV Melanoma
Photodynamic Therapy in Treating Patients With Stage III or Stage IV Melanoma
For Condition: stage 3 melanoma,Stage 4 Melanoma,Recurrent Melanoma
Status: No longer recruiting
Sponsor(s): QLT Inc ,
Synopsis: RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. Photodynamic therapy may be effective in treating melanoma. PURPOSE: Phase I/II trial to study the effectiveness of photodynamic therapy in treating patients who have stage III or stage IV melanoma.
Details: OBJECTIVES: I. Determine the safety of photodynamic therapy with verteporfin and Detox-B adjuvant in patients with stage III or IV melanoma. II. Determine the clinical response in patients treated with this regimen. III. Determine whether this regimen induces systemic cellular and humoral immune responses to melanoma antigens in these patients. IV. Determine the ablation of cutaneous tumors in patients treated with this regimen. PROTOCOL OUTLINE: This is a multicenter study. Patients undergo photodynamic therapy with verteporfin and Detox-B adjuvant. Treatment repeats every 2 weeks for a total of 3 courses, each to a different melanoma lesion. Both non-treated and treated tumors are measured prior to study and at months 2, 4, and 6. Immune profile is also assessed prior to study and at months 2, 4, and 6. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 12 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Diagnosis of stage III or IV melanoma - At least 3 cutaneous tumors for treatment (treatment tumors) AND 1-7 additional cutaneous, visceral, or lymph node tumors for response assessment (marker tumors); Treatment tumors must be on trunk, arms, or legs AND be 1.0-3.6 cm in - Measurable disease by calipers or CT scan - No CNS metastases by CT scan --Prior/Concurrent Therapy-- - Biologic therapy: At least 4 weeks since prior biologic therapy or immunotherapy; No concurrent biologic therapy - Chemotherapy: At least 4 weeks since prior chemotherapy; No concurrent chemotherapy - Endocrine therapy: Not specified - Radiotherapy: At least 4 weeks since prior radiotherapy; No concurrent radiotherapy - Surgery: No concurrent surgical removal of melanoma lesions designated for treatment or response assessment - Other: No other concurrent therapy for melanoma --Patient Characteristics-- - Age: Over 18 - Performance status: ECOG 0-2 - Life expectancy: Not specified - Hematopoietic: WBC at least 2,500/mm3; Neutrophil count at least 1,000/mm3; Platelet count at least 50,000/mm3; Hemoglobin at least 9 g/dL; Hematocrit at least 27% - Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN); AST/ALT no greater than 2 times ULN; Alkaline phosphatase no greater than 2.5 times ULN - Renal: Creatinine no greater than 2 times ULN
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GraemeBoniface, Study Chair, QLT Inc
University of Colorado Cancer Center
Denver, Colorado, 80010
United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213-3489
United States
Missouri Baptist Cancer Center
St. Louis, Missouri, 63131
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
United States
Mount Sinai Comprehensive Cancer Center at Aventura
Aventura, Florida, 33180
United States
Mount Sinai Comprehensive Cancer Center
Miami, Florida, 33140
United States
Additional Information:
Study ID Numbers: CDR0000068358; QLT-PHO-VFI-PDV-01,QLT-VFI-PDV-01
Study Start Date: October 2000
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00007969
Other Recurrent Melanoma Studies:
1. Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Metastatic Kidney Cancer
2. Antineoplaston Therapy in Treating Patients With Stage IV Melanoma
3. Vaccine Plus Interleukin-2 in Treating Patients With Advanced Melanoma
4. Tipifarnib in Treating Patients With Metastatic Malignant Melanoma
5. Interferon alfa Plus Radiation Therapy in Treating Patients With Stage III or Recurrent Melanoma That Has Been Removed by Surgery
Related Studies:
Other Recurrent Melanoma Clinical Trials
Other Pennsylvania Clinical Trials
Other Pittsburgh Clinical Trials
Photodynamic Therapy in Treating Patients With Stage III or Stage IV Melanoma
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