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Response of In-Transit Melanoma to Systemic Treatment With the Specific Active Immunotherapeutic Agent, Canvaxin™


Phase 2
18 Years
80 Years
Open (Enrolling)
Both
Melanoma (Skin)

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Trial Information

Response of In-Transit Melanoma to Systemic Treatment With the Specific Active Immunotherapeutic Agent, Canvaxin™


OBJECTIVES:

- Determine the response in patients with in-transit cutaneous malignant melanoma treated
with active immunotherapy comprising polyvalent melanoma vaccine (Canvaxin™).

OUTLINE: This is an open-label, multicenter study.

Patients receive polyvalent melanoma vaccine (Canvaxin™) subcutaneously to the armpit and
groin areas every 2 weeks for approximately 10 weeks (5 doses) and then every 4 weeks for up
to approximately 1 year of total treatment (total of 15 doses). Patients with no evidence of
response at week 24 receive no further treatment. Patients whose disease continues to
respond after completion of study treatment are eligible for a new study in which they will
continue treatment with polyvalent melanoma vaccine (Canvaxin™).

After completion of study treatment, patients are followed at 30 days.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed malignant melanoma

- At least 1 in-transit skin lesion measuring 3-10 mm in the longest diameter

PATIENT CHARACTERISTICS:

Age

- 18 to 80

Performance status

- Not specified

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- Not specified

Renal

- Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response

Safety Issue:

No

Principal Investigator

Linda Strause

Investigator Role:

Study Chair

Investigator Affiliation:

CancerVax Corporation

Authority:

United States: Federal Government

Study ID:

CDR0000439529

NCT ID:

NCT00128583

Start Date:

July 2005

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • stage III melanoma
  • Melanoma

Name

Location

Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283
CCOP - DaytonKettering, Ohio  45429
LDS HospitalSalt Lake City, Utah  84143
Simmons Cancer Center at University of Texas Southwestern Medical Center at DallasDallas, Texas  75390
M.D. Anderson Cancer Center at University of TexasHouston, Texas  77030
Lakeland Regional Cancer Center at Lakeland Regional Medical CenterLakeland, Florida  33805
H. Lee Moffitt Cancer Center and Research Institute at University of South FloridaTampa, Florida  33612
John Wayne Cancer Institute at Saint John's Health CenterSanta Monica, California  90404
Comprehensive Cancer Center at Desert Regional Medical CenterPalm Springs, California  92262