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

NCT ID: NCT00005841

Last Updated: 2014-05-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-06-30
• Study Completion Date: 2002-10-31

Brief 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.

Detailed 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.

Conditions

Intraocular Melanoma; Melanoma (Skin)

Study Design

• Primary Study Purpose: TREATMENT

Interventions

MART-1 antigen

Intervention Type: BIOLOGICAL

gp100 antigen

Intervention Type: BIOLOGICAL

incomplete Freund's adjuvant

Intervention Type: BIOLOGICAL

progenipoietin

Intervention Type: BIOLOGICAL

tyrosinase peptide

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey S. Weber, MD, PhD

Role: STUDY_CHAIR

University of Southern California

Locations

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

City of Hope National Medical Center

Los Angeles, California, United States

Countries

United States

References

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):1301-12.

Reference Type: RESULT

PMID: 12684398 (View on PubMed)

Other Identifiers

LAC-USC-10M993

Identifier Type: -

Identifier Source: secondary_id

LAC-USC-IRB-99B028

Identifier Type: -

Identifier Source: secondary_id

NCI-470

Identifier Type: -

Identifier Source: secondary_id

CDR0000067857 (10M-99-3)

Identifier Type: -

Identifier Source: org_study_id