Injection Of AJCC Stage IIB, IIC, III And IV Melanoma Patients With A Multi-Epitope Peptide Vaccine Using GM-CSF DNA As An Adjuvant: A Pilot Trial To Assess Safety And Immunity
N/A
N/A
Both
Melanoma (Skin)
Trial Information
Injection Of AJCC Stage IIB, IIC, III And IV Melanoma Patients With A Multi-Epitope Peptide Vaccine Using GM-CSF DNA As An Adjuvant: A Pilot Trial To Assess Safety And Immunity
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and recommended dose of sargramostim (GM-CSF)
plasmid DNA adjuvant with a multi-epitope peptide vaccine comprising tyrosinase peptide
and gp100 antigen in patients with stage IIB, IIC, III, or IV melanoma who are
HLA-A2-positive.
- Determine the safety of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
- Determine the dose-limiting toxic effects of this regimen in these patients.
- Determine the immunogenicity of this regimen in these patients.
Secondary
- Determine any anti-tumor response in patients treated with this regimen.
OUTLINE: This is a phase I, pilot, dose-escalation study of sargramostim (GM-CSF) plasmid
DNA adjuvant followed by a phase II, pilot study.
- Phase I: Patients receive GM-CSF plasmid DNA adjuvant subcutaneously (SC) on day 1 and
a vaccine comprising tyrosinase peptide and gp100 antigen SC on day 5. Treatment
repeats every 28 days for a total of 3 courses in the absence of disease progression or
unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of GM-CSF plasmid DNA adjuvant until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
- Phase II: Patients receive vaccination as in phase I at the MTD. After completion of
study, patients are followed up for 1 year.
PROJECTED ACCRUAL: A total of 3-27 patients (3-18 for phase I and 9 for phase II) will be
accrued for this study within 2-14 months.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed malignant melanoma
- Stage IIB, IIC, III, or IV disease
- Patients with resectable disease must have undergone surgical resection before study
entry
- Patients free of disease after surgical resection are eligible up to 6 months
after resection
- HLA-A0201 positive
- No detectable brain metastases by brain MRI or CT scan
PATIENT CHARACTERISTICS:
Age
- Any age if weight > 25 kg (55 lb)
Performance status
- Karnofsky 80-100%
Life expectancy
- Not specified
Hematopoietic
- WBC ≥ 3,000/mm^3
- Platelet count ≥ 100,000/mm^3
- No active bleeding
Hepatic
- Lactic dehydrogenase ≤ 2 times upper limit of normal (ULN)
- Albumin ≥ 3.5 mg/dL
- AST ≤ 2 times ULN
Renal
- Creatinine ≤ 2 mg/dL
- No prior creatinine > 2 mg/dL
Other
- Must weigh ≥ 25 kg
- No medical condition that would preclude study participation (e.g., active autoimmune
disease or immunodeficiency)
- No pre-existing retinal or choroidal eye disease
- No inflammation of the eyes
- No serious underlying medical conditions
- No active infection requiring antimicrobial drugs
- Not pregnant or nursing
- At least 3 months post-partum
- Negative pregnancy test
- Fertile patients must use effective barrier contraception during and for 3 months
after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 4 weeks since prior immunotherapy
- No prior vaccines containing tyrosinase peptide or gp100 antigen or peptides derived
from tyrosinase peptide or gp100 antigen
- No other concurrent immunotherapy
Chemotherapy
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
- No concurrent chemotherapy
Endocrine therapy
- More than 6 weeks since prior systemic corticosteroids
- Inhaled or nasal steroids allowed
Radiotherapy
- More than 4 weeks since prior radiotherapy
- No concurrent radiotherapy
Surgery
- See Disease Characteristics
- Recovered from prior surgery
Other
- Recovered from all prior therapy
- No concurrent medication that would preclude study participation
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Outcome Measure:
Immunological efficacy in terms of T-cell response as measured by enzyme-linked immunospot
Safety Issue:
No
Principal Investigator
Miguel-Angel Perales, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000367330
NCT ID:
NCT00085137
Start Date:
December 2003
Completion Date:
Related Keywords:
- Melanoma (Skin)
- recurrent melanoma
- stage II melanoma
- stage III melanoma
- stage IV melanoma
- Melanoma
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
