Vaccine Therapy in Treating HLA-A2 Positive Patients With Melanoma

NCT00003895 | Completed Phase 2 Results

• 7 other identifiers: NCI-2013-02096CDR0000067065NCI-T98-0081PPMC-IRB-99-999-9T98-0081R21CA082614
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized pilot phase II trial studies how well vaccine therapy works in treating human leukocyte antigen class 1 histocompatibility, A-2 (HLA-A2) positive patients with melanoma. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells.

Conditions

Recurrent Melanoma; Stage IA Melanoma; Stage IB Melanoma; Stage IIA Melanoma; Stage IIB Melanoma; Stage IIC Melanoma; Stage IIIA Melanoma; Stage IIIB Melanoma; Stage IIIC Melanoma

Outcome Measures

Primary Outcomes (1)

• T Cell Immunity to gp100 Peptide and to E7 12-20 Papilloma Virus Peptide

  Frequency measures obtained from each assay will be transformed to (common) logs for purposes of analysis. Repeated measures analyses will be performed on longitudinal data to assess patients' immune response profiles over time. Comparability of assay methods will be assessed with correlation analyses, regression analyses, standard parametric and nonparametric tests, and agreement methods. Pre- and post-immunization T-cell immunity to g209-2M peptide, to HPV16E7 peptide, and to a negative control HLA-A2 HIV peptide (pol) were assessed using HLA-A2/peptide tetramer-specific binding analysis. Within-subject analyses were performed to determine differences between pre- and postimmunization responses to the g209 -2M and HPV peptides and to the negative control HIV peptide after completion of 6 months of vaccination. Pre- versus postimmunization response differences were used as criterion measures in between-group (among subjects) analyses.

  Baseline to 6 months

Study Arms (2)

gp100:209-217(210M) + HPV 16 E7:12-20 (every 2 weeks)

EXPERIMENTAL

Patients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine mixed with incomplete Freund's adjuvant SC every 2 weeks for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo laboratory biomarker analysis.

Biological: HPV 16 E7:12-20; Biological: gp100:209-217(210M); Other: laboratory biomarker analysis

gp100:209-217(210M) + HPV 16 E7:12-20 (every 3 weeks)

EXPERIMENTAL

Patients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine mixed with incomplete Freund's adjuvant SC every 3 weeks for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo laboratory biomarker analysis.

Biological: HPV 16 E7:12-20; Biological: gp100:209-217(210M); Other: laboratory biomarker analysis

Interventions

HPV 16 E7:12-20 BIOLOGICAL

Given SC

gp100:209-217(210M) + HPV 16 E7:12-20 (every 2 weeks); gp100:209-217(210M) + HPV 16 E7:12-20 (every 3 weeks)

gp100:209-217(210M) BIOLOGICAL

Given SC

Also known as: G9 209-2M

gp100:209-217(210M) + HPV 16 E7:12-20 (every 2 weeks); gp100:209-217(210M) + HPV 16 E7:12-20 (every 3 weeks)

laboratory biomarker analysis OTHER

Correlative studies

gp100:209-217(210M) + HPV 16 E7:12-20 (every 2 weeks); gp100:209-217(210M) + HPV 16 E7:12-20 (every 3 weeks)

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically confirmed primary melanoma of Breslow thickness 1.0-4.0 mm; patients who have had only their initial biopsy are preferred; however, those who have already undergone a wide local excision are also eligible; patients may be enrolled up to three months after their wide local excision
• Patients whose melanoma is \> 4.0 mm thick who have positive or negative regional lymph nodes are also eligible
• After accrual to the original 26 patient goal, all patients must be enrolled prior to sentinel lymph node dissection; patients with previous lymph node dissection will not be eligible
• Patients must be HLA typed and be shown to be HLA-A2.1+ by either serologic techniques, flow cytometry, or molecular techniques
• Patients must be ambulatory with good performance status (Karnofsky performance status \[PS\] 80-100)
• White blood cell (WBC) \>= 3500/mm\^3
• Platelets (Plt) \>= 100,000/mm\^3
• Hemoglobin \>= 9 gm/100 ml
• Serum creatinine =\< 2 mg/dl
• Total bilirubin =\< 2.0 mg/dl
• Patients must have recovered from any effects of major surgery and be free of significant systemic infection
• Patients must be negative for human immunodeficiency virus (HIV) antibody by enzyme-linked immunosorbent assay (ELISA) (or negative by Western blot if ELISA is positive) if they are considered to be at high risk; others do not require serologic testing if there are no symptoms or risk factors for HIV disease
• Women of childbearing potential must have a negative pregnancy test and should avoid becoming pregnant while on treatment
• Patients must give written informed consent prior to initiation of therapy; patients with a history of major psychiatric illness must be judged able to fully understand the investigational nature of the study and the risks associated with the therapy

You may not qualify if:

• Patients must not have clinically detectable distant metastases
• Patients who require or are likely to require systemic corticosteroids for intercurrent illness
• Patients with any significant medical disease other than the malignancy (e.g. chronic obstructive pulmonary disorder \[COPD\], patients with ascites or pleural effusions) which in the opinion of the investigator would significantly increase the risk of immunotherapy
• Patient should be free of any other cancers or deemed at low risk for their recurrence

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Walter J. Urba, MD, PhD; Physician Director of Research
• Organization: Providence Cancer Center, Earle A. Chiles Research Institute, Robert W. Franz Cancer Center

Walter.Urba@providence.org

503-215-5696

Study Officials

• Walter J. Urba, MD, PhD

  Providence Cancer Center, Earle A. Chiles Research Institute, Robert W. Franz Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: July 18, 2003
• Study Start: April 1, 1999
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: February 20, 2017
• Results First Posted: February 20, 2017

Record last verified: 2016-12

Locations

US (1)