Know Cancer

or
forgot password

A Randomized Phase II Trial to Determine the Immune Response to a Mutated gp100 Mela


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

Thank you

Trial Information

A Randomized Phase II Trial to Determine the Immune Response to a Mutated gp100 Mela


OBJECTIVES:

- Determine the toxic effects of gp100:209-217 (210M) and human papilloma virus (HPV)-16
E7(12-20) peptide vaccine in patients with primary melanoma at least 1 mm thick.

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

- Determine the T-cell response to the control HLA-A2.1-restricted cytotoxic T-lymphocyte
epitope of HPV-16 E7(12-20) in these patients.

- Determine whether analysis of antigen-specific T cells using specific HLA-A2/peptide
tetramers is an effective method for monitoring the immune response in patients
undergoing peptide vaccination compared to ELISPOT, LDA, and measurement of
intracellular cytokine production (fastimmune).

- Compare induction of primary peptide-specific T-cell immune responses to self gp100
peptide versus foreign E7 peptide in these patients.

- Compare immune response induced by vaccinating every 2 weeks for 6 months (13
vaccinations) vs every 3 weeks for 6 months (9 vaccinations) in these patients.

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

- Arm I: Patients receive gp100:209-217 (210M) and HPV-16 E7(12-20) peptides mixed with
Montanide ISA-51 subcutaneously at the site of the primary melanoma and in the
extremities and abdomen. Vaccinations continue every 2 weeks for 6 months (13 total
injections).

- Arm II: Patients receive vaccinations as in arm I every 3 weeks for 6 months (9 total
injections).

Patients undergo sentinel lymph node biopsy and possible wide local excision approximately
10 days after the second vaccination.

Patients are followed every 3 months for 6 months, every 4 months for 1 year, every 6 months
for 3 years, and then annually thereafter until recurrence.

PROJECTED ACCRUAL: A total of 36 patients (18 per arm) will be accrued for this study within
14 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically proven primary melanoma of Breslow thickness at least 1.0 mm

- Prior wide local excision allowed if within past 3 months

- No prior lymph node dissection

- HLA-A2 positive

- No ascites or pleural effusions

- No clinically detectable distant metastases

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 2.0 mg/dL

Renal:

- Creatinine no greater than 2 mg/dL

Pulmonary:

- No chronic obstructive pulmonary disease

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No significant systemic infection

- HIV negative

- No history of major psychiatric illness that would preclude study compliance

- No concurrent illness requiring systemic corticosteroids

- No other significant medical illness that would increase risk of immunotherapy

- No other cancers or deemed at low risk of recurrence

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- Not specified

Endocrine therapy:

- No concurrent systemic corticosteroids

Radiotherapy:

- Not specified

Surgery:

- See Disease Characteristics

- Recovered from prior major surgery

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

John W. Smith, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Providence Cancer Center, Earle A. Chiles Research Institute

Authority:

United States: Federal Government

Study ID:

CDR0000067065

NCT ID:

NCT00003895

Start Date:

April 1999

Completion Date:

July 2003

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