Safety Study of Adjuvant Vaccine to Treat Melanoma Patients

Completed · Phase 1/Phase 2

Conditions studied: Melanoma

In brief

The incidence of melanoma is increasing with an estimated incidence of 59,940 cases and an annual death rate of 8110 in 2007. Although patients diagnosed with early stage disease have an excellent clinical outcome, patients diagnosed with advanced or recurrent disease, continue to have a high mortality rate, even with initial optimal surgical resection. Effective adjuvant strategies are needed to increase the time to progression and to decrease the recurrence rate. Immunotherapy has long been recognized as a potential therapy for melanoma; the goal of adjuvant vaccine therapy is to train the endogenous immune system to recognize and target minimal residual disease.

Key facts

Study ID

NCT01079741

Run by

Nina Bhardwaj

People needed

34

Starts

2010-09-01

Expected to finish

2013-03-11

Last updated by the study team

2018-02-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histological diagnosis of malignant melanoma, stages IIB-IV in radiologically confirmed cCr without clinical evidence of disease.
• At least 4 weeks since surgery prior to first dosing of study agent.
• Laboratory values within the following limits:
• Hemoglobin > 10.0 g/dL
• Neutrophil count > 1.5 x l09/L
• Lymphocyte count > Lower limit of institutional normal
• Platelet count > 80 x l09/L
• Serum creatinine < 2.0 mg/dL
• Serum bilirubin < 2 x upper limit of institutional normal
• AST/ALT < 2 x upper limit of institutional normal
• Patients must have an ECOG performance status of <2 (ECOG criteria published in [67].
• Life expectancy > 6 months.
• Age > 18 years.
• Able and willing to give written informed consent for participation in the trial (see Section 12.2).

You may not qualify if…

• Serious illnesses, e.g., serious infections requiring antibiotics.
• Previous bone marrow or stem cell transplant.
• History of immunodeficiency disease (such as HIV) or autoimmune disease except vitiligo.
• Metastatic disease to the central nervous system.
• Other malignancy within 3 years prior to entry into the study, except for treated early-stage melanoma or non-melanoma skin cancer, or cervical carcinoma in situ.
• Prior chemotherapy or vaccine therapy.
• Radiation therapy, biological therapy or surgery within 4 weeks prior to first dose of study agent.
• Concomitant treatment with systemic corticosteroids greater than physiologic doses. Topical (but not at the proposed vaccination sites) or inhalational steroids are permitted.
• Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dose of study agent.
• Pregnancy or lactation.
• Women of childbearing potential not using a medically acceptable means of contraception.
• Psychiatric or addictive disorders that may compromise the ability to give informed consent.
• Lack of availability of the patient for immunological and clinical follow-up assessment.
• Children <18 years of age who cannot undergo the leukapheresis procedure, do not meet the disease staging and/or the size criteria for frequent blood donations

Where it is running

• New York University Langone Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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