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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00007969
First received: January 6, 2001
Last updated: November 5, 2013
Last verified: August 2008
  Purpose

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.


Condition Intervention Phase
Melanoma (Skin)
Biological: Detox-B adjuvant
Drug: verteporfin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase 1/2 Uncontrolled, Open Label Study Of Photodynamic Vaccination In Patients With Stage III/IV Malignant Melanoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: October 2000
Detailed Description:

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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00007969

Locations
United States, Colorado
University of Colorado Cancer Center
Denver, Colorado, United States, 80010
United States, Florida
Mount Sinai Comprehensive Cancer Center at Aventura
Aventura, Florida, United States, 33180
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States, 33140
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
United States, Missouri
Missouri Baptist Cancer Center
Saint Louis, Missouri, United States, 63131
United States, Pennsylvania
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15213-3489
Sponsors and Collaborators
QLT Inc.
Investigators
Study Chair: Graeme R. Boniface, PhD QLT Inc.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00007969     History of Changes
Other Study ID Numbers: CDR0000068358, QLT-VFI-PDV-01, QLT-PHO-VFI-PDV-01
Study First Received: January 6, 2001
Last Updated: November 5, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III melanoma
stage IV melanoma
recurrent melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Verteporfin
Detox adjuvant
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses
Adjuvants, Immunologic
Immunologic Factors

ClinicalTrials.gov processed this record on July 29, 2014