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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


Phase 1/Phase 2
N/A
N/A
Not Enrolling
Both
Melanoma (Skin)

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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 CenterNew York, New York  10021