Know Cancer

or
forgot password

A Phase I Study of Peptide Based Vaccine Therapy in Patients With High-Risk or Metastatic Melanoma


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Melanoma (Skin)

Thank you

Trial Information

A Phase I Study of Peptide Based Vaccine Therapy in Patients With High-Risk or Metastatic Melanoma


OBJECTIVES:

- Compare the safety of melanoma peptide vaccine with or without sargramostim (GM-CSF) in
patients with high-risk or metastatic melanoma.

- Compare changes in peptide-specific cellular and humoral immunologic profiles in
patients treated with these regimens.

- Compare tumor response in patients treated with these regimens.

OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 2 treatment
arms.

- Arm I: Patients receive melanoma peptide vaccine comprising tyrosinase leader injected
at 2 separate sites, Melan-A ELA injected at another site, NY-ESO-1a and NY-ESO-1b
combined and injected at one site, and MAGE-10.A2 injected at another site,
intradermally once weekly on weeks 1-6.

- Arm II: Patients receive vaccine as in arm I. Patients also receive sargramostim
(GM-CSF) subcutaneously daily beginning 2 days before each vaccination and continuing
for 5 days.

Treatment in both arms continues through week 6 in the absence of disease progression or
unacceptable toxicity.

Patients are followed at 2 weeks.

PROJECTED ACCRUAL: A total of 20 patients (10 per treatment arm) will be accrued for this
study within 18 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed high-risk stage III or IV melanoma

- Stage III disease less than 6 months after surgical resection

- Completed prior interferon alfa therapy OR

- Progressive disease or major adverse events during prior interferon alfa
therapy

- Stage III disease at least 6 months after surgical resection

- Declined, failed, or completed prior standard therapy

- Stage IV disease

- Declined, failed, or completed prior standard therapy

- HLA-A2 positive

- No CNS metastases unless treated and stable

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 80-100%

Life expectancy:

- At least 4 months

Hematopoietic:

- Neutrophil count at least 1,500/mm3

- Lymphocyte count at least 500/mm3

- Platelet count at least 100,000/mm3

- Hemoglobin at least 9.0 g/dL (10.0 g/dL if less than 50 kg)

- No bleeding disorder

Hepatic:

- Bilirubin no greater than 2.0 mg/dL

- No hepatitis B or C positivity

Renal:

- Creatinine no greater than 1.8 mg/dL

Cardiovascular:

- No New York Heart Association class III or IV heart disease

Other:

- HIV negative

- No other serious illness

- No serious infection requiring antibiotics

- No history of immunodeficiency disease or autoimmune disease

- No psychiatric or addictive disorder that would preclude study

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- See Disease Characteristics

- No prior bone marrow or stem cell transplantation

- At least 4 weeks since prior immunotherapy or biologic therapy

- No other concurrent immunotherapy or biologic therapy

Chemotherapy:

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)

- No concurrent chemotherapy

Endocrine therapy:

- No concurrent systemic corticosteroids

- No concurrent steroids except topical or inhalational steroids

- Concurrent hormonal therapy allowed

Radiotherapy:

- At least 4 weeks since prior radiotherapy

Surgery:

- See Disease Characteristics

- At least 4 weeks since prior surgery

Other:

- At least 4 weeks since prior investigational agents

- Concurrent noncytotoxic anticancer therapy allowed

- No concurrent immunosuppressive therapy

- No concurrent antihistamines

- No concurrent non-steroidal anti-inflammatory drugs except in low doses for
prevention of an acute cardiovascular event or pain control

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Kyriakos P. Papadopoulos, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Herbert Irving Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000069357

NCT ID:

NCT00037037

Start Date:

October 2001

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • stage III melanoma
  • stage IV melanoma
  • recurrent melanoma
  • Melanoma

Name

Location

Herbert Irving Comprehensive Cancer Center at Columbia UniversityNew York, New York  10032