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

Primary Purpose

Melanoma (Skin)

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Autologous dendritic cell-adenovirus CCL21 vaccine

About this trial

This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage III melanoma, stage IV melanoma, recurrent melanoma, mucosal melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

H. Lee Moffitt Cancer Center and Research Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vaccine Dose Escalation

Arm Description

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

Outcomes

Primary Outcome Measures

Number of Participants with Immune response

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.

Secondary Outcome Measures

Number of Participants with Adverse Events

Toxicity as assessed by NCI CTCAE v3.0

Full Information

NCT ID

NCT00798629

First Posted

November 25, 2008

Last Updated

September 21, 2012

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00798629

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Completed

Study Start Date

November 2008 (undefined)

Primary Completion Date

April 2012 (Actual)

Study Completion Date

April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Melanoma (Skin)

Keywords

stage III melanoma, stage IV melanoma, recurrent melanoma, mucosal melanoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vaccine Dose Escalation

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Autologous dendritic cell-adenovirus CCL21 vaccine

Other Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of Participants with Immune response

Description

Time Frame

2 years, 5 months

Secondary Outcome Measure Information:

Title

Number of Participants with Adverse Events

Description

Toxicity as assessed by NCI CTCAE v3.0

Time Frame

2 years, 5 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeffrey S. Weber, MD, PhD

Organizational Affiliation

H. Lee Moffitt Cancer Center and Research Institute

Official's Role

Study Chair

Facility Information:

Facility Name

H. Lee Moffitt Cancer Center and Research Institute

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612-9497

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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