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A Pilot Trial of Therapeutic Vaccination With a Modified gp100 Melanoma Peptide (gp100:209-217(210M)), Montanide ISA 51, and KLH With Reconstitution After Chemotherapy to Induce Lymphopenia in Patients With Metastatic Melanoma

Phase 1
18 Years
Not Enrolling
Melanoma (Skin)

Thank you

Trial Information

A Pilot Trial of Therapeutic Vaccination With a Modified gp100 Melanoma Peptide (gp100:209-217(210M)), Montanide ISA 51, and KLH With Reconstitution After Chemotherapy to Induce Lymphopenia in Patients With Metastatic Melanoma



- Determine the toxicity and immune effects of vaccination comprising modified gp100
peptide (gp100:209-217[210M]), Montanide ISA-51, and keyhole limpet hemocyanin followed
by peripheral blood mononuclear cell reinfusion after treatment-induced lymphopenia
with fludarabine in patients with unresectable or metastatic melanoma.

- Determine the induction of antigen-specific T-cell responses in patients treated with
this regimen.

- Determine the kinetics and duration of immune response in patients treated with this

- Compare the immunologic effects of this regimen in these patients with historical


- Compare 2 different dosing schedules of fludarabine, in terms of induction of
lymphopenia and granulocytopenia and on the induction of a specific immune response to
this vaccine, in these patients.

OUTLINE: This is a pilot, randomized study. Patients are randomized to 1 of 2 treatment

Within 2 weeks before the start of fludarabine, all patients undergo leukapheresis over 4-6
hours for the collection of peripheral blood mononuclear cells (PBMCs).

- Arm I: Patients receive fludarabine IV over 30 minutes on days 1-5.

- Arm II: Patients receive fludarabine as in arm I on days 1, 3, and 5. In both arms,
patients receive autologous PBMCs IV over approximately 30 minutes on day 8 and
vaccination comprising gp100:209-217(210M) peptide, Montanide ISA-51, and keyhole
limpet hemocyanin subcutaneously on days 8, 22, 36, 50, and 64. Patients with stable or
responding disease continue to receive vaccination on day 78 and then every 28-31 days
for up to 1 year.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 20 patients (10 per treatment arm) will be accrued for this
study within 2 years.

Inclusion Criteria


- Histologically or cytologically confirmed malignant melanoma

- Metastatic or unresectable disease

- Measurable disease

- HLA-A2 positive

- Received at least 1 prior immunotherapy and/or chemotherapy regimen for metastatic
disease (first 6 patients only)

- No known brain metastases unless previously treated with radiotherapy and/or surgery
AND is stable for at least 1 month after treatment



- 18 and over

Performance status

- ECOG 0-2 OR

- Karnofsky 60-100%

Life expectancy

- More than 3 months


- WBC ≥ 3,000/mm^3

- Absolute neutrophil count ≥ 1,500/mm^3

- Absolute lymphocyte count ≥ 500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 10 g/dL (transfusions allowed)

- Hematocrit ≥ 24%

- No other active bleeding


- Bilirubin < 2 times upper limit of normal (ULN) (unless due to Gilbert's disease)

- AST and ALT < 3 times ULN

- Hepatitis B surface antigen negative

- Hepatitis C antibody negative


- Creatinine < 2 mg/dL

- No uncontrolled hypercalcemia


- No uncontrolled symptomatic congestive heart failure

- No unstable angina pectoris

- No uncontrolled cardiac arrhythmia

- No uncontrolled hypertension


- No uncontrolled bronchospasm

- No hemoptysis


- Negative serology for all of the following:

- HIV-1 and HIV-2

- HTLV-1 and -2

- Syphilis

- Rheumatoid factor < 43 units/μL

- Anti-nuclear antibody < 11 units/μL

- No history of multiple sclerosis, systemic lupus erythematosus, or myasthenia gravis

- No primary or secondary immunodeficiency

- No active infection

- No allergy to seafood or shellfish that would preclude study participation


- No active gastrointestinal bleeding

- No uncontrolled hyperglycemia

- No other medical or psychiatric condition or social situation that would preclude
study compliance

- No other uncontrolled illness

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 3-4 months after
study participation


Biologic therapy

- See Disease Characteristics

- No prior immunization with gp100:209-217(210M) peptide


- See Disease Characteristics

- More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

Endocrine therapy

- More than 2 weeks since prior steroid therapy except replacement steroids or inhaled

- No concurrent corticosteroids except replacement steroids

- No concurrent dexamethasone


- See Disease Characteristics

- More than 2 weeks since prior radiotherapy


- See Disease Characteristics

- Recovered from prior surgery


- No other concurrent investigational agents

- No other concurrent anticancer therapy

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Toxicity by clinical and laboratory observation at 1 month

Safety Issue:


Principal Investigator

Walter J. Urba, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Providence Cancer Center, Earle A. Chiles Research Institute


United States: Federal Government

Study ID:




Start Date:

July 2004

Completion Date:

March 2010

Related Keywords:

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



Providence Cancer Center at Providence Portland Medical Center Portland, Oregon  97213-2967