Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Vaccine Therapy in Treating Patients With Melanoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	Over 16	NCI	PPMC-IRB-99-9 NCI-T98-0081, NCT00003895, T98-0081

Objectives

1. 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.
2. Determine the T-cell response to modified self-gp100:209-217 (210M) peptide and unmodified parental gp100 peptide in these patients.
3. 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.
4. 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).
5. Compare induction of primary peptide-specific T-cell immune responses to self gp100 peptide versus foreign E7 peptide in these patients.
6. 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.

Entry 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

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

Patient Characteristics:

Age:

• Over 16

Performance status:

• Karnofsky 80-100%

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,500/mm³
• Platelet count at least 100,000/mm³
• 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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Providence Cancer Center at Providence Portland Medical Center

John Smith, MD, Protocol chair(Contact information may not be current)		Ph: 503-215-6259

Registry Information
Official Title		A Randomized Phase II Trial to Determine the Immune Response to a Mutated gp100 Mela
Trial Start Date		1999-04-22
Registered in ClinicalTrials.gov		NCT00003895
Date Submitted to PDQ		1999-05-07
Information Last Verified		2002-12-10
NCI Grant/Contract Number		R21-CA82614