Photodynamic Therapy in Treating Patients With Stage III or Stage IV Melanoma

NCT00007969 | Completed Phase 1

• 3 other identifiers: CDR0000068358QLT-VFI-PDV-01QLT-PHO-VFI-PDV-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Melanoma (Skin)

Keywords

stage III melanoma; stage IV melanoma; recurrent melanoma

Interventions

Detox-B adjuvant BIOLOGICAL

verteporfin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 longest dimension Measurable disease by calipers or CT scan No CNS metastases by CT scan 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 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• QLT Inc.: lead

Study Sites (6)

University of Colorado Cancer Center

Denver, Colorado, 80010, United States

Location

Mount Sinai Comprehensive Cancer Center at Aventura

Aventura, Florida, 33180, United States

Location

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, 33140, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Missouri Baptist Cancer Center

St Louis, Missouri, 63131, United States

Location

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15213-3489, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

detox adjuvant; Verteporfin

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Porphyrins; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Graeme R. Boniface, PhD

  QLT Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 6, 2001
• First Posted: March 11, 2004
• Study Start: October 1, 2000
• Last Updated: November 6, 2013

Record last verified: 2008-08

Locations

US (6)