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Mature Dendritic Cell Vaccination Against gp100 in Patients With Advanced Melanoma

Phase 1
18 Years
Open (Enrolling)

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Trial Information

Mature Dendritic Cell Vaccination Against gp100 in Patients With Advanced Melanoma

Eligible patients that provide written informed consent will undergo apheresis to collect
blood mononuclear cells for vaccine production. All patients will be given cyclophosphamide
300mg/m2 IV three days prior to vaccine dose #1 in order to deplete regulatory T cells. All
patients will receive mature DC for each dose of vaccine. For each dose all patients will
receive autologous dendritic cells pulsed with 2 gp100 melanoma peptides (G209-2M and
G280-9V) plus up to an additional 10 unique melanoma tumor-specific peptides. All patients
will receive booster doses with mature DC. The DC vaccine will be given intravenously every
three weeks for a total of six vaccine doses. Peripheral blood (16 ml) will be taken weekly
to monitor the immune response to each peptide by tetramer assay. Apheresis is repeated
after vaccine dose #3 and dose #6 in order to collect PBMC for immune monitoring. Restaging
is performed after three and six vaccine doses. Patients with stable disease or better
(partial response/complete response) after six doses will be eligible to receive additional
vaccinations as maintenance therapy every 2 months until progression.

Inclusion Criteria:

- Unresectable stage III and stage IV M1a/M1b/M1c melanoma including patients with
uveal melanoma

- Age ≥ 18 years

- Life expectancy ≥ 4 months

- ECOG performance status 0-2

- HLA-A2 positive

- gp100 expression > 6% in primary lesion or metastasis

- At least 28 days from prior treatment (including adjuvant interferon) except in cases
of a BRAF inhibitor (such as vemurafenib); concurrent treatment with a BRAF inhibitor
is permitted

- Required initial laboratory values (submitted within 14 days prior to registration):

- WBC >3,000/mm3

- Hg ≥ 9.0 gm/dl Platelets >75,000/mm3 Serum Bilirubin < 2.0 mg/dl Serum
Creatinine < 2.0 mg/dl

- Sexually active women of childbearing potential must use effective birth control
during the trial and for at least two months following the trial, and sexually active
men must be willing to avoid fathering a new child while receiving therapy.

Exclusion Criteria:

- Prior treatment with more than one line of cytotoxic chemotherapy; prior treatment
with one line of cytotoxic chemotherapy is permitted. Prior treatment with targeted
therapy (such as ipilumumab, and BRAF inhibitor) is permitted

- Active untreated CNS metastasis

- Active infection

- Prior malignancy (except non-melanoma skin cancer) within 3 years

- Pregnant or nursing

- Concurrent treatment with corticosteroids; local (inhaled or topical) steroids are

- Inability to provide adequate informed consent

- Known allergy to eggs

- Prior history or uveitis or autoimmune inflammatory eye disease.

- Known positivity for hepatitis BsAg, hepatitis C antibody, or HIV antibody.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the immunological response based on measuring increased numbers of peptide specific CD8+ T cells as calculated by the tetramer assay.

Outcome Description:

Starting on Day 0, two tubes will be drawn weekly until Day 64. Thereafter, two tubes will be drawn every 21 days until Day 190. For patients receiving maintenance treatment, blood is drawn every month.

Outcome Time Frame:

Through completion of treatment

Safety Issue:


Principal Investigator

Gerald P. Linette, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine


United States: Food and Drug Administration

Study ID:

07-0652 / 201103308



Start Date:

August 2008

Completion Date:

September 2013

Related Keywords:

  • Melanoma
  • Melanoma



Washington University St. Louis, Missouri  63110