Clinical trial NCT00334776: Vaccine Therapy in Treating Patients With Metastatic Melanoma
Official title: A Phase II Trial of an Intradermally Administered MART-1gp100/Tyrosinase Peptide-Pulsed Dendritic Cell Vaccine Matured With a Cytokine Cocktail for Patients With Metastatic Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Intraocular Melanoma
Melanoma (Skin)
Keywords: recurrent melanoma
stage IV melanoma
ciliary body and choroid melanoma, medium/large size
iris melanoma
recurrent intraocular melanoma
extraocular extension melanoma
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-06-08
Enrollment: 6
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill melanoma cells.

PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with metastatic melanoma.

Detailed description: OBJECTIVES:

Primary

* Determine clinical response in HLA-A \*0201-positive patients with metastatic melanoma treated with an intradermally administered vaccine comprising autologous dendritic cells pulsed with MART-1, gp100, and tyrosinase peptides and matured with a cytokine cocktail.

Secondary

* Determine immunologic response in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients undergo apheresis to collect dendritic cells (DC). Autologous DC are pulsed ex vivo with tumor antigen peptides derived from MART-1: 26-35 (27L), gp100: 209-217 (210M), and tyrosinase: 368-376 (370D) and matured with a cytokine cocktail comprising interleukin (IL)-4, IL-6, IL-1β, sargramostim (GM-CSF), tumor necrosis factor-α, and prostaglandin E2.

Patients receive 12 intradermal injections of DC vaccine over 30 minutes on days 1, 8, 22, and 36. Treatment repeats every 8 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically until disease progression.

PROJECTED ACCRUAL: A total of 41 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of melanoma

  * Metastatic disease
  * The following melanoma subtypes are eligible:

    * Unresectable, stage III-IV uveal melanoma
    * Metastatic mucosal melanoma
* Measurable disease after attempted curative surgical therapy
* Tumor tissue must be available for immunohistochemical staining

  * Positive for ≥ 1 of the following peptides:

    * MART-1: 26-35 (27L)
    * gp100: 209-217 (210M)
    * Tyrosinase: 368-376 (370D)
* HLA-A \*0201 positive by DNA polymerase chain reaction assay

PATIENT CHARACTERISTICS:

* ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%
* Creatinine ≤ 2.0 mg/dL
* Bilirubin ≤ 2.0 mg/dL
* WBC ≥ 3,000/mm\^3
* Platelet count ≥ 75,000/mm\^3
* Hemoglobin ≥ 9.0 g/dL
* No major systemic infections
* No coagulation disorders
* No major medical illness of the cardiovascular or respiratory system
* No myocardial infarction within the past 6 months
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No known HIV positivity
* No know positivity for hepatitis B surface antigen or hepatitis C antibody
* No prior uveitis or autoimmune inflammatory eye disease
* No other prior malignancy except cervical carcinoma in situ or basal cell skin cancer unless patient was curatively treated \> 5 years ago and has no detectable disease

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No more than 1 prior cytotoxic chemotherapy agent or regimen
* Prior biologic or antiangiogenic therapies allowed
* More than 1 month since prior and no concurrent radiotherapy, chemotherapy, adjuvant therapy, or any other therapy for melanoma
* No prior MART-1: 26-35 (27L), gp100: 209-217 (210M), or tyrosinase: 368-376 (370D) peptides
* No concurrent steroid therapy

Primary outcomes:
measure: Overall survival
measure: Progression-free survival
measure: Time to progression
measure: Toxicity
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center and Hospital
state: California
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
Study officials:
affiliation: University of Southern California
name: Jeffrey S. Weber, MD, PhD
role: STUDY_CHAIR
References: