Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma

NCT00390338 | Completed Phase 1 DMC

• 6 other identifiers: 03-118PCI-UPCI-03-118NCI-7089PCI-IRB-0409071CDR0000504518NCI-2009-00125
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Vaccines made from a person's dendritic cells mixed with tumor peptides and proteins may help the body build an effective immune response to kill tumor cells. Infusing the vaccine directly into the lymphatic system may cause a stronger immune response and kill more tumor cells. PURPOSE: This randomized phase I trial is studying the side effects and best dose of two dendritic cell vaccines in treating patients with stage III or stage IV melanoma.

Conditions

Melanoma (Skin)

Keywords

recurrent melanoma; stage IV melanoma; stage IIIA melanoma; stage IIIB melanoma; stage IIIC melanoma

Outcome Measures

Primary Outcomes (1)

• Safety of intralymphatic autologous type-1-polarized dendritic cell vaccine and autologous mature dendritic cell vaccine

  7 years

Secondary Outcomes (1)

• Assess immune responses to each dendritic cell vaccine outcome

  7

Study Arms (2)

peptide-pulsed type-1-polarized dendritic cells

EXPERIMENTAL

intralymphatic vaccination with peptide-pulsed type-1-polarized dendritic cells (aDC1)

Biological: polarized dendritic cells

peptide-pulsed mature non-polarized dendritic cells (cDCs)

EXPERIMENTAL

intralymphatic vaccination with peptide-pulsed mature non-polarized dendritic cells (cDCs)

Biological: non-polarized dendritic cells

Interventions

polarized dendritic cells BIOLOGICAL

peptide-pulsed type-1-polarized dendritic cells

non-polarized dendritic cells BIOLOGICAL

peptide-pulsed mature non-polarized dendritic cells (cDCs)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Pathologically confirmed stage III or IVA (M1a) melanoma * Recurrent and inoperable disease * Any tumor thickness and any number of lymph nodes involved * Asymptomatic cutaneous and nodal disease allowed * Asymptomatic pulmonary metastatic disease (stage IVB, M1b) allowed * No advanced symptomatic visceral disease, including any symptomatic visceral organ involvement, or disease associated with increased serum lactic dehydrogenase \> 2.5 times upper limit of normal (stage IVC, M1c) * Standard curative or palliative measures do not exist or are no longer effective * Sufficient numbers of monocytes (≥ 20 x 10\^6) must be obtained for the preparation of the vaccine * If an insufficient number of cells is obtained on first venipuncture, a second venipuncture may be performed (not exceeding 550 mL of blood within 8 weeks) * No brain metastases by contrast-enhanced CT scan or MRI * Prior brain metastases allowed provided they were successfully treated and patient has been asymptomatic for ≥ 3 months * HLA-A2 positive PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Life expectancy ≥ 6 months * Granulocyte count ≥ 1,500/mm³ * Lymphocyte count ≥ 500/mm³ * Platelet count \> 70,000/mm³ (for venipuncture/pheresis procedure) * Creatinine ≤ 1.5 times upper limit of normal (ULN) * AST and ALT ≤ 2.5 times ULN * Gamma-glutamyl transferase ≤ 2.5 times ULN * Lactic dehydrogenase ≤ 2.5 times ULN * Alkaline phosphatase ≤ 2.5 times ULN * Bilirubin ≤ 1.5 times ULN * No active infection * No sensitivity to drugs that provide local anesthesia * No pain uncontrolled by oral analgesics, including opiates and opiate analogs * No active autoimmune disease * No HIV, hepatitis B, or hepatitis C positivity * Not pregnant or nursing * Fertile patients must use effective contraception * Negative pregnancy test * No other malignancy except for nonmelanoma skin cancers or carcinoma in situ of the cervix, or other malignancy for which the patient has been continuously disease-free for ≥ 2 years PRIOR CONCURRENT THERAPY: * Recovered from prior surgery * No radiotherapy, chemotherapy, or immunotherapy within the past 4 weeks (6 weeks for nitrosoureas or mitomycin C) * No antibiotics within the past 7 days * No systemic immunosuppressive agents, including steroids, within the past 4 weeks * Concurrent maintenance steroids for adrenal insufficiency allowed * No other concurrent anticancer investigational or commercial agents or therapies

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Pawel Kalinski: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

UPMC Cancer Center at Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

UPMC Cancer Centers

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ahmad A. Tarhini, MD, MS

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Surgery and Immunology

Study Record Dates

• First Submitted: October 18, 2006
• First Posted: October 19, 2006
• Study Start: October 1, 2006
• Primary Completion: May 1, 2012
• Study Completion: January 1, 2015
• Last Updated: September 26, 2017

Record last verified: 2017-09

Locations

US (2)