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

NCT00398073 | Completed Phase 1 Results

• 2 other identifiers: 06-113MSKCC-06113
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intraocular Melanoma; Melanoma (Skin)

Keywords

stage II melanoma; stage III melanoma; stage IV melanoma; recurrent melanoma; ciliary body and choroid melanoma, medium/large size; ciliary body and choroid melanoma, small size; recurrent intraocular melanoma; metastatic intraocular melanoma

Outcome Measures

Primary Outcomes (2)

• Number of Patients Evulated for Toxicity and Safety

  All toxicity will be graded according to the National Cancer Institute (NCI) Common Toxicity Criteria v3.0.

  2 years

• Number of Participants With a T-cell Response

  T-cell response: Peripheral blood lymphocytes will be tested for reactivity against gp100 using an IFN-y ELISPOT, intracellular cytokine staining or MHC tetramer assay. If T-cell reactivity is induced, additional samples may be drawn to determine the duration of this reactivity. Follow-up blood samples require only 20-30 ml. MHC tetramer assays and intracellular flow cytometry studies may also be performed.

  2 years

Secondary Outcomes (1)

• Number of Participants With Response

  2 years

Study Arms (2)

mouse gp100 DNA via PMED

EXPERIMENTAL

patients will be randomized to mouse gp100 DNA delivered via gold particles using the PowderMed delivery system (ND10, described above). Two actuations/day will be administered every two weeks for 4 months for a total of 16 actuations. Each actuation consists of 2 μg of plasmid DNA coated onto 1000 μg of gold. The total dose of plasmid DNA given will be 32 μg DNA on 16,000 μg gold.

Biological: mouse gp100 plasmid DNA vaccine; Device: The Dermal PowderMed® devices

mouse gp100 DNA injections intramuscularly

EXPERIMENTAL

patients will be injected with 1000 μg of mouse gp100 plasmid DNA intramuscularly. Two injections/day will be administered every two weeks for 4 months (4000 ug of mouse gp100 plasmid/month) for 16 vaccinations.

Biological: mouse gp100 plasmid DNA vaccine; Other: intramuscularly (IM injection)

Interventions

mouse gp100 plasmid DNA vaccine BIOLOGICAL

mouse gp100 DNA injections intramuscularly; mouse gp100 DNA via PMED

The Dermal PowderMed® devices DEVICE

mouse gp100 DNA via PMED

intramuscularly (IM injection) OTHER

mouse gp100 DNA injections intramuscularly

Eligibility Criteria

• Age: 1 Year - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Uveal Melanoma; Melanoma

Interventions

Injections, Intramuscular

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Jedd Wolchok, MD, Chief Attending
• Organization: Memorial Sloan Kettering Cancer Center

wolchokj@MSKCC.ORG

+1646-888-2315

Study Officials

• Jedd D. Wolchok, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2006
• First Posted: November 10, 2006
• Study Start: October 1, 2006
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: March 16, 2017
• Results First Posted: March 16, 2017

Record last verified: 2017-01

Locations

US (1)