Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma

Melanoma (Skin) Clinical Trial

Official title:

A Phase I Trial of a Vaccine Combining Tyrosinase/GP100/Mart-1 Peptides Emulsified With Montanide ISA 51 With ProGP for Patients With Resected Stages III and IV Melanoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00005841
• Other study ID #: CDR0000067857 (10M-99-3)
• Secondary ID: LAC-USC-10M993LA
• Status: Terminated
• Phase: Phase 1
• First received: June 2, 2000
• Last updated: May 20, 2014
• Start date: June 2000
• Est. completion date: October 2002

Study information

• Verified date: May 2014
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Vaccines made from melanoma cells may make the body build an immune response to kill tumor cells. Vaccine therapy plus filgrastim combined with a specific protein may be a more effective treatment for melanoma.

PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with stage III or stage IV melanoma that has been completely removed during surgery.

Description:

OBJECTIVES: I. Determine the maximum tolerated dose of filgrastim (G-CSF)-fetal liver tyrosine kinase-3 (Flt3K) fusion protein when combined with melanoma peptide vaccine comprising tyrosinase:368-376 peptide, gp100:209-217 antigen, and MART-1:26-35 antigen emulsified in Montanide ISA-51 in patients with completely resected stage III or IV melanoma. II. Determine the toxicity and safety of this regimen in these patients. III. Determine the immune responses to tyrosinase, MART-1, and gp100 antigens in patients before, during, and after receiving these vaccinations.

OUTLINE: This is a dose escalation, multicenter study of filgrastim (G-CSF)-fetal liver tyrosine kinase-3 (Flt3K) (G-CSF-Flt3K) fusion protein. Patients receive melanoma peptide vaccine comprising tyrosinase:368-376 peptide, gp100:209-217 antigen, and MART-1:26-35 antigen emulsified in Montanide ISA-51 subcutaneously (SQ) monthly for 6 months, and then at 9 and 12 months for a total of 8 vaccinations. Patients receive G-CSF-Flt3K fusion protein SQ daily for 3 days before, immediately after, and then daily for 6 days after each vaccination. Cohorts of 6-10 patients receive escalating doses of G-CSF-Flt3K fusion protein until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6-10 patients experience dose limiting toxicity. Patients are followed every 3 months through year 2 after resection, every 6 months for 3 years, and then annually thereafter until disease progression.

PROJECTED ACCRUAL: A total of 30-50 patients will be accrued for this study within 12-18 months.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: October 2002
• Est. primary completion date: December 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS: Histologically proven completely resected stage III or IV cutaneous, mucosal, or ocular melanoma Disease free, but at high risk of relapse Must meet 1 of the following criteria: Failed interferon alfa (IFN-A) therapy Ineligible for IFN-A therapy Refused IFN-A therapy HLA-A2.1 positive Availability of tumor tissue for analysis of gp100 antigen staining with antibody HMB-45, and for expression of tyrosinase and MART-1 antigens by immunohistochemistry Tumor cells must be positive for at least 1 antigen

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0 or 1 Life expectancy:

Not specified Hematopoietic: WBC at least 3,000/mm3 Granulocyte count at least 1,500/mm3 Hemoglobin at least 9.0 g/dL Platelet count at least 100,000/mm3 No coagulation or bleeding disorders Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT and SGPT no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No concurrent major medical illness of the cardiovascular system Pulmonary: No concurrent major medical illness of the respiratory system Immunologic: Hepatitis B surface antigen negative and hepatitis C antibody negative HIV negative No history of uveitis or other autoimmune inflammatory eye disease No other active autoimmune disease No known allergic reaction to Montanide ISA-51 Other: No concurrent major systemic infection including pneumonia or sepsis No concurrent major medical illness of the gastrointestinal system Not pregnant or nursing Negative pregnancy test No other malignancy within the past 5 years except curatively treated squamous cell skin cancer or carcinoma in situ of the cervix allowed 30 days after treatment

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No prior tyrosinase:368-376 peptide, gp100:209-217 antigen, or MART-1:26-35 antigen Chemotherapy: Not specified Endocrine therapy: No concurrent steroids Radiotherapy: At least 1 month since prior radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics Other: At least 1 month since other prior therapy, including adjuvant therapy, for melanoma No other concurrent anticancer therapy

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intraocular Melanoma
• Melanoma
• Melanoma (Skin)
• Uveal Neoplasms

Intervention

Biological:
• MART-1 antigen

• gp100 antigen

• incomplete Freund's adjuvant

• progenipoietin

• tyrosinase peptide

Locations

Country	Name	City	State
United States	City of Hope National Medical Center	Los Angeles	California
United States	USC/Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Pullarkat V, Lee PP, Scotland R, Rubio V, Groshen S, Gee C, Lau R, Snively J, Sian S, Woulfe SL, Wolfe RA, Weber JS. A phase I trial of SD-9427 (progenipoietin) with a multipeptide vaccine for resected metastatic melanoma. Clin Cancer Res. 2003 Apr;9(4):1 — View Citation