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A Pilot Study To Access The Immunologic Response To Booster Vaccination With A Modified gp100 Melanoma Peptide (209-2M) Vaccine In Previously Vaccinated HLA-A2.1+ Patients With Melanoma


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

Thank you

Trial Information

A Pilot Study To Access The Immunologic Response To Booster Vaccination With A Modified gp100 Melanoma Peptide (209-2M) Vaccine In Previously Vaccinated HLA-A2.1+ Patients With Melanoma


OBJECTIVES:

- Determine the toxicity of booster vaccination with gp100:209-217 (210M) peptide and
HPV-16 E7 (12-20) peptide vaccine emulsified in Montanide ISA-51 administered at least
12 months after prior vaccination in patients with melanoma.

- Determine T-cell response to modified gp100: 209-217 (210M) peptide and unmodified
native gp100 peptide in these patients.

- Determine T-cell response to the control HLA-A2-restricted CD8 epitope of HPV-16 E7
(12-20) peptide vaccine in these patients.

OUTLINE: Patients undergo leukapheresis on day 0. Patients receive vaccination comprising
gp100:209-217 (210M) and HPV-16 E7 (12-20) peptide vaccine emulsified in Montanide ISA-51
subcutaneously (SC) on day 1 and between days 25-30 in the absence of disease progression or
unacceptable toxicity. Patients undergo a second leukapheresis 2-4 weeks after the second
vaccination.

Patients who remain disease free for 6 months after the second vaccination may receive
additional booster vaccinations SC every 6 months for 3 years.

Patients are followed at 3 and 6 months after the second vaccination and then every 6 months
thereafter.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 1.5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Completed treatment on PPMC-IRB-99-9*

- At least 12 months since last vaccination NOTE: *Patients are not required to
have received every planned vaccine as long as the reason for stopping was not
disease progression or dose-limiting toxicity

- No current evidence of melanoma, as defined by one of the following:

- Disease-free since completion of PPMC-IRB-99-9

- Recurrence occurred but was completely resected

PATIENT CHARACTERISTICS:

Age

- Over 16

Performance status

- Karnofsky 80-100%

Life expectancy

- Not specified

Hematopoietic

- WBC at least 3,500/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 9 g/dL

Hepatic

- Bilirubin no greater than 2 mg/dL

Renal

- Creatinine no greater than 2 mg/dL

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for at least 6 months
after study participation

- No other concurrent medical or psychiatric illness that would preclude study
participation

- No concurrent significant systemic infection

- No other concurrent cancer or at low risk for recurrence of prior cancers

PRIOR CONCURRENT THERAPY:

Biologic therapy

- See Disease Characteristics

Chemotherapy

- Not specified

Endocrine therapy

- No concurrent systemic corticosteroids for intercurrent illness

Radiotherapy

- Not specified

Surgery

- Recovered from prior major surgery

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Walter J. Urba, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Providence Cancer Center, Earle A. Chiles Research Institute

Authority:

United States: Federal Government

Study ID:

CDR0000258479

NCT ID:

NCT00052988

Start Date:

October 2002

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • stage I melanoma
  • stage II melanoma
  • stage III melanoma
  • Melanoma

Name

Location

Earle A. Chiles Research Institute at Providence Portland Medical CenterPortland, Oregon  97213-2967