Know Cancer

or
forgot password

Phase II Trial for the Evaluation of the Efficacy of Vaccination With Synthetic Melanoma Peptides Either Pulsed on Dendritic Cells, or Administered With GM-CSF-in-Adjuvant, Plus Administration of Sustemic IL-2, in Patients With Advanced Melanoma.


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

Thank you

Trial Information

Phase II Trial for the Evaluation of the Efficacy of Vaccination With Synthetic Melanoma Peptides Either Pulsed on Dendritic Cells, or Administered With GM-CSF-in-Adjuvant, Plus Administration of Sustemic IL-2, in Patients With Advanced Melanoma.


OBJECTIVES: I. Compare the effectiveness of vaccination with synthetic melanoma peptides
pulsed on autologous dendritic cells versus vaccination with synthetic melanoma peptides
plus sargramostim (GM-CSF) in decreasing tumor burden in patients with high risk melanoma
(pulsed autologous dendritic cell arm closed 1/8/2001). II. Determine whether these regimens
result in increased tumor specific immune responses as measured in vitro and in vivo. III.
Determine whether these regimens stimulate T-cell responses in these patients.

OUTLINE: This is an open label study. Patients are included in treatment arm II only (arm I
closed 1/8/2001): Arm I: Patients undergo leukapheresis to collect dendritic cells. Patients
receive a mixture of synthetic melanoma peptides (gp100 antigen, tyrosinase, and tetanus
peptides) pulsed on autologous dendritic cells IV and subcutaneously (SC). Arm II: Patients
receive a mixture of synthetic melanoma peptides (gp100 antigen, tyrosinase, and tetanus
peptides) and sargramostim (GM-CSF) emulsified in Montanide ISA-51 SC and intradermally.
Patients receive vaccination during weeks 0, 1, 2, 4, 5, and 6 for a total of 6 doses and
interleukin-2 SC daily on days 7-49. Patients receive 3 additional vaccinations at different
sites not involved with the tumor concurrently with the first 3 vaccinations. Patients are
evaluated at 8 weeks, 12 weeks, 6 months, 12 months, and 24 months.

PROJECTED ACCRUAL: A total of 27-54 patients will be accrued for this study within 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage III or IV
melanoma gp100 positive tumor cells and/or tyrosinase positive tumor cells HLA type A1,
A2, or A3 Measurable disease May have up to 3 brain metastases if all are less than 2 cm
in diameter and are asymptomatic, and there is no mass effect or they have been treated
successfully by surgical excision or by gamma knife radiation therapy

PATIENT CHARACTERISTICS: Age: 18 to 79 Performance status: ECOG 0-1 Life expectancy: Not
specified Hematopoietic: Absolute neutrophil count greater than 1,000/mm3 Platelet count
greater than 100,000/mm3 Hemoglobin greater than 9 g/dL Hepatic: Bilirubin no greater than
2.5 times upper limit of normal (ULN) AST and ALT no greater than 2.5 times ULN Alkaline
phosphatase no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN
Cardiovascular: No New York Heart Association class II, III, or IV heart disease Other: No
known or suspected allergy to any component of the vaccine No medical condition that would
preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use
effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 months since prior growth factors
At least 3 months since prior agents with putative immunomodulating activity (except
nonsteroidal antiinflammatory agents) At least 1 year since other prior melanoma
vaccinations Chemotherapy: At least 3 months since prior chemotherapy No concurrent
chemotherapy Endocrine therapy: At least 3 months since prior corticosteroids No
concurrent corticosteroids Radiotherapy: At least 3 months since prior radiotherapy No
concurrent radiotherapy Surgery: See Disease Characteristics Other: At least 3 months
since other prior investigational drugs or therapy At least 3 months since prior allergy
desensitization injections At least 14 days since completion of acute treatment for a
serious infection No concurrent allergy desensitization injections

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Craig L. Slingluff, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Virginia

Authority:

United States: Federal Government

Study ID:

CDR0000066084

NCT ID:

NCT00003222

Start Date:

April 1998

Completion Date:

Related Keywords:

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

Name

Location

Cancer Center at the University of VirginiaCharlottesville, Virginia  22908