Phase 2
N=3
Safety Study of Adjuvant Vaccine to Treat Melanoma Patients
Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT01079741 ↗Enrolled (actual)
3
Serious AEs
2.9%
Results posted
Feb 2018
Primary outcome: Primary: Phase I, Number of Participants With SAE and DLT — 0; 0; 1; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- NY-ESO-1 protein; Poly-ICLC; Montanide (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Nina Bhardwaj
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase I, Number of Participants With SAE and DLT |
0; 0; 1; 0; 0; 0 | — |
| SECONDARY CD4+ and CD8+ Response |
10; 9; 1; 4 | — |
| SECONDARY NY-ESO-1 Expression by IHC |
1.500; 1.944; 1.318; 2.167; 1.091; 1.222 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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 6 months.
- Age > 18 years.
- Able and willing to give written informed consent for participation in the trial (see Section 12.2).
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01079741). 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.