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A Phase 1/2 Uncontrolled, Open Label Study Of Photodynamic Vaccination In Patients With Stage III/IV Malignant Melanoma


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Melanoma (Skin)

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Trial Information

A Phase 1/2 Uncontrolled, Open Label Study Of Photodynamic Vaccination In Patients With Stage III/IV Malignant Melanoma


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Graeme R. Boniface, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

QLT Inc.

Authority:

United States: Federal Government

Study ID:

CDR0000068358

NCT ID:

NCT00007969

Start Date:

October 2000

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • stage III melanoma
  • stage IV melanoma
  • recurrent melanoma
  • Melanoma

Name

Location

University of Colorado Cancer CenterDenver, Colorado  80262
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
Mount Sinai Comprehensive Cancer CenterMiami Beach, Florida  33140
Missouri Baptist Cancer CenterSt. Louis, Missouri  63131
Mount Sinai Comprehensive Cancer Center at AventuraAventura, Florida  33180