Vaccine Therapy in Treating Patients with Recurrent Stage IIIC-IV Melanoma

Status: Temporarily Closed to Accrual and Intervention

Description

This phase I trial studies the side effects and the best dose of vaccine therapy in treating patients with stage IIIC-IV melanoma that has come back. Vaccines made from a person's tumor cells and proteins may help the body build an effective immune response to kill tumor cells.

Eligibility Criteria

Inclusion Criteria

  • Participants must have histologically or cytologically confirmed stage IV melanoma or recurrent stage IIIc melanoma following primary treatment of surgery and prior treatment or consideration of adjuvant therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • No known allergy or adverse reaction (e.g., wound dehiscence) to poly-lactide-co-glycolide (PLG)
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  • Ability to understand and the willingness to sign a written informed consent document
  • >= 3 weeks from protocol tissue procurement since treatment (surgery, chemo-, radiation-, hormone- therapy, check point blockade [e.g., anti-CTLA-4, PD-1, PDL-1]); (windows are in relation to the date of the protocol tissue procurement)
  • Participants must have recovered from any acute toxicity associated with prior therapy
  • >= 4 weeks from protocol tissue procurement since resolution of all immune related toxicities and off systemic steroids >= 4 weeks; prophylactic use of steroids in preparation for radiologic exams are acceptable
  • History of central nervous system (CNS) disease is acceptable if effectively treated and demonstrated stable disease for >= 2 months from protocol tissue procurement
  • Participants must have a clinical indication for resection of metastatic melanoma; patients will be informed about other treatment options for stage IV melanoma including Braf inhibitors and antibodies to CTLA-4

Exclusion Criteria

  • Participants may not be receiving any other investigational study agents or treatment for their cancer
  • Active autoimmune disease requiring treatment for suppression of inflammation with the exception of autoimmune thyroiditis
  • History of allergic reactions or adverse reactions (e.g., wound dehiscence) attributed to compounds of similar chemical or biologic composition to PLG or known hypersensitivity to GM-CSF, CPG or PLG
  • Uncontrolled intercurrent illness including, but not limited to uncontrolled active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or other condition that in the judgment of the principal investigator would interfere with the surgical implantation of the scaffold
  • Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with WDVAX
  • Individuals with a history of a different malignancy are ineligible except for the following circumstances; individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin
  • Human immunodeficiency virus (HIV)-positive individuals are ineligible

Locations & Contacts

See trial information on ClinicalTrials.gov for a list of participating sites.

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To determine the feasibility of preparing dendritic cells activating scaffolds of autologous melanoma necrotic cell lysate, human granulocyte-macrophage colony-stimulating factor (GM-CSF), and oligodeoxynucleotide containing unmethylated cytosine and guanine (CpG) (WDVAX) incorporating autologous melanoma cell lysates in patients with histologically or cytologically confirmed, metastatic melanoma.

II. To determine the safety and biologic activity of vaccination with dendritic cell activating scaffolds (WDVAX) incorporating autologous melanoma cell lysates in patients with metastatic melanoma.

SECONDARY OBJECTIVES:

I. To estimate immune response.

II. To estimate overall survival.

III. Correlative studies will explore the longitudinal behavior or peripheral blood immune cells and dendritic cell subtypes.

OUTLINE: This is a dose-escalation study.

Patients receive scaffold autologous WDVAX implant on days 0, 28, 56, and 84 or days 0, 21, 42, and 63 or days 0, 14, 28, and 42 in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 1 month and then every 3 months thereafter.

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Treatment

Lead Organization

Lead Organization
Dana-Farber Harvard Cancer Center

Principal Investigator
Frank Stephen Hodi

Trial IDs

Primary ID 12-306
Secondary IDs NCI-2013-01799
Clinicaltrials.gov ID NCT01753089