Phase 1 N=35 Randomized Treatment

Vaccine Therapy in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Melanoma

Intraocular Melanoma · Melanoma (Skin)

Bottom Line

View on ClinicalTrials.gov: NCT00398073 ↗

Enrolled (actual)

Serious AEs

11.8%

Results posted

Mar 2017

Primary outcome: Primary: Number of Patients Evulated for Toxicity and Safety — 17; 17 participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: mouse gp100 plasmid DNA vaccine (Biological); The Dermal PowderMed® devices (Device); intramuscularly (IM injection) (Other)
Age: Pediatric, Adult, Older Adult · 1+ yrs
Sex: All
Sponsor: Memorial Sloan Kettering Cancer Center
Primary completion: Mar 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients Evulated for Toxicity and Safety	17; 17	—
PRIMARY Number of Participants With a T-cell Response	17; 17	—
SECONDARY Number of Participants With Response	17; 17	—

Summary

RATIONALE: Vaccines made from DNA may help the body build an effective immune response to kill tumor cells. Giving the vaccine in different ways may make a stronger immune response and kill more tumor cells. PURPOSE: This randomized clinical trial is studying two different ways of giving vaccine therapy to compare how well they work in treating patients with stage IIB, stage IIC, stage III, or stage IV melanoma.

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed malignant melanoma
Stage IIB, IIC, III, or IV disease
Patients free of disease after surgical resection must meet 1 of the following criteria:
Refused high-dose interferon alfa
Recurrence while on interferon alfa
Patients with stage IIB, IIC, or III disease must have already undergone initial standard therapy (i.e., surgery) for the disease
Choroidal (uveal) melanoma allowed provided 1 of the following criteria is met:
Basal diameter > 16 mm
Basal height > 8 mm
Involvement of the ciliary body with tumor
HLA-A*0201 positive
Negative serum antidouble-stranded DNA antibody screen
No known brain metastases

PATIENT CHARACTERISTICS:

Karnofsky performance status 80-100%
Platelet count ≥ 100,000/mm^3
Absolute neutrophil count ≥ 1,500/mm^3
WBC ≥ 3,000/mm^3
Lactic dehydrogenase ≤ 2 times upper limit of normal (ULN)
Creatinine ≤ 2.0 mg/dL
Bilirubin ≤ 2.5 times ULN
Albumin ≥ 3.5 mg/dL
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Weight ≥ 25 kg
No preexisting choroidal eye disease
No serious underlying medical conditions that could be exacerbated by study participation (i.e., active infections requiring antimicrobial drugs or active bleeding)
No allergy to gold (i.e., gold jewelry)
No evidence of any condition at the proposed site(s) of vaccine administration that might interfere with the interpretation of local skin reactions, including any of the following:
Damaged skin
Moles
Scars
Tattoos
Marks
No prior medical condition or use of medication (e.g., corticosteroids) that might make it difficult for the patient to complete the full course of treatment or to respond immunologically to vaccines
No history or evidence (within the past 5 years) of a physician-diagnosed chronic or recurrent inflammatory skin disease at the proposed site of vaccine administration, including any of the following:
Psoriasis
Eczema
Atopic dermatitis
Hypersensitivity
No history of keloid formation

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
At least 4 weeks since prior chemotherapy, immunotherapy, or radiotherapy (6 weeks for nitrosoureas) and recovered
No prior immunization with any class of vaccine containing gp100 peptide
No other concurrent investigational agents
No other concurrent systemic therapy or radiotherapy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00398073). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.