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A Dose Ranging Trial of Adenovirus CCL-21 Transduced MART-1/gp100 Peptide-Pulsed Dendritic Cells Matured Using Cytokines for Patients With Chemotherapy-Resistant Metastatic Melanoma

Phase 1
18 Years
Not Enrolling
Melanoma (Skin)

Thank you

Trial Information

A Dose Ranging Trial of Adenovirus CCL-21 Transduced MART-1/gp100 Peptide-Pulsed Dendritic Cells Matured Using Cytokines for Patients With Chemotherapy-Resistant Metastatic Melanoma

In this phase I study, patients will receive intradermal injections of adenovirus-CCL-21
transduced class I peptide-pulsed DC with total volumes for each intradermal injection of no
more than 1 ml to be split into four injections of 0.25 ml each in four limbs in node
draining areas (proximal arms and thighs), for a total DC dose of 2 X 10^6, 10^7 or 2 X 10^7
cells to be administered intradermally. DC injections in one course of therapy will be given
four times at intervals of weekly for two doses (days 1 and 8 +/- 72 hrs.), then every two
weeks for two doses (at days 22 +/- 72 hrs. and 36 +/- 72 hours). Cells will be harvested
for DC administration and a flow cytometry analysis as well as microbiologic analysis
including bacterial/fungal cultures and gram stain will be performed prior to infusion. All
injections will be based on number of DC, not number of total cells.

Inclusion Criteria:

- Metastatic melanoma with measurable disease after attempted curative surgical therapy
and who have received at least one prior chemotherapy regimen; adjuvant interferon or
isolated limb perfusion is allowed.

- Tumor tissue must be available for immunohistochemical analysis, and specimens will
stained for MART-1 by immunohistochemical staining and will also be stained for
HMB-45 by immunohistochemistry, and positivity for at least one will be an entry

- Patients must be HLA-A *0201 positive, by a DNA SSOP analysis.

- Serum creatinine of 2.0 mg/dl or less, total bilirubin of 2.0 mg/dl or less, and
ALT/AST of less than 3X institutional upper limit of normal.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Patients must be able to understand and sign an IRB approved informed consent form.

- Patients must have white blood count of 3000 or greater, platelets of 100,000 or
greater, and hemoglobin of 9.0 gm/dl or more.

- Patients with unresectable stages III/IV uveal melanoma and metastatic mucosal
melanoma will be eligible for this trial.

Exclusion Criteria:

- Undergoing or have undergone in the past month any other therapy for their melanoma,
including radiation therapy, chemotherapy and adjuvant therapy

- Have major systemic infections, coagulation disorders, or other major medical
illnesses of the cardiovascular or respiratory systems, or have had a documented MI
in the last 6 months

- Require steroid therapy

- Patients who are pregnant or lactating

- Known to be positive for hepatitis BsAg, Hepatitis C or HIV antibody

- Have a prior history of uveitis or autoimmune inflammatory eye disease

- Have had another malignancy other than cervical carcinoma-in-situ or basal cell
/squamous cancer of the skin, unless they have undergone curative therapy more than 3
years ago and are still free of detectable disease, since the effects of
peptide-pulsed DC on other active cancers are unknown

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants with Immune response

Outcome Description:

Assessment of immune responses to the cytokine-cocktail-matured class I peptide-pulsed adenoviral CCL-21 transduced DC cell vaccine. Immune reactivity will be monitored for the appearance of lymphoid-like structures at the vaccine site (as a result of CCL-21 production), in the blood for MART-1 /gp100 specific T cell frequency by tetramer based flow cytometry and ELISPOT analysis of fresh cells, and CTL cytolytic reactivity after in vitro sensitization prior to, four weeks after, and 8 weeks after immunization.

Outcome Time Frame:

2 years, 5 months

Safety Issue:


Principal Investigator

Jeffrey S. Weber, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

November 2008

Completion Date:

April 2012

Related Keywords:

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



H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612