Vaccine Therapy in Treating Patients With Melanoma - Full Text View

Sponsor:	Providence Cancer Center, Earle A. Chiles Research Institute
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003895

Purpose

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: Randomized phase II trial to compare the effectiveness of two different regimens of melanoma vaccine in treating patients who have melanoma.

Condition	Intervention	Phase
Melanoma (Skin)	Biological: HPV 16 E7:12-20 peptide vaccine Biological: gp100 antigen Biological: incomplete Freund's adjuvant Procedure: conventional surgery	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	A Randomized Phase II Trial to Determine the Immune Response to a Mutated gp100 Mela

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Freund's adjuvant

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

April 1999

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003895

Locations

United States, Oregon
Earle A. Chiles Research Institute at Providence Portland Medical Center
Portland, Oregon, United States, 97213-2967

Sponsors and Collaborators

Providence Cancer Center, Earle A. Chiles Research Institute

National Cancer Institute (NCI)

Investigators

Study Chair:

John W. Smith, MD

Providence Cancer Center, Earle A. Chiles Research Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000067065, PPMC-IRB-99-9, NCI-T98-0081
Study First Received:	November 1, 1999
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00003895 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I melanoma
stage II melanoma
stage III melanoma

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunologic Factors
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Adjuvants, Immunologic
Pharmacologic Actions
Melanoma

Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms
Neoplasms, Germ Cell and Embryonal
Nevi and Melanomas
Freund's Adjuvant

ClinicalTrials.gov processed this record on November 22, 2009