Adenovirus CCL-21 Transduced MART-1/gp100/Tyrosinase/NY-ESO-1 Peptide-Pulsed Dendritic Cells Matured

NCT ID: NCT00798629

Last Updated: 2012-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2012-04-30

Brief Summary

RATIONALE: Vaccines made from gene-modified tumor cells may help the body build an immune response to kill tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with metastatic melanoma.

Detailed Description

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.

Conditions

Melanoma (Skin)

Keywords

stage III melanoma; stage IV melanoma; recurrent melanoma; mucosal melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vaccine Dose Escalation

Dose Escalation: Intradermal DC Injection. Level 1: Cell Dose: 2 x 10\^6 Level 2: Cell Dose: 1 x 10\^7 Level 3: Cell Dose: 2 x 10\^7

Group Type: EXPERIMENTAL

Autologous dendritic cell-adenovirus CCL21 vaccine

Intervention Type: BIOLOGICAL

Intradermal injections of adenovirus-CCL-21 transduced class I peptide-pulsed DC

Interventions

Autologous dendritic cell-adenovirus CCL21 vaccine

Intradermal injections of adenovirus-CCL-21 transduced class I peptide-pulsed DC

Intervention Type: BIOLOGICAL

Other Intervention Names

gp100:209-217(210M)Peptide; NSC 683472; MART-1:26-35(27L)Peptide; NSC 709401; dendritic cell (DC)

Eligibility Criteria

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 requirement.
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey S. Weber, MD, PhD

Role: STUDY_CHAIR

H. Lee Moffitt Cancer Center and Research Institute

Locations

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Countries

United States

Other Identifiers

NCI P-8190

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

MCC-15280

Identifier Type: -

Identifier Source: org_study_id