Vaccine Therapy and Interleukin-12 With Either Alum or Sargramostim After Surgery in Treating Patients With Melanoma

NCT ID: NCT00031733

Last Updated: 2014-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-02-28
• Study Completion Date: 2007-11-30

Brief Summary

RATIONALE: Vaccines made from peptides may make the body build an immune response. Combining vaccine therapy with interleukin-12 and either alum or sargramostim may kill more tumor cells.

PURPOSE: Randomized phase II trial to compare the effectiveness of combining vaccine therapy with interleukin-12 and either alum or sargramostim in treating patients who have undergone surgery for stage II, stage III, or stage IV melanoma.

Detailed Description

OBJECTIVES:

• Compare the immune reactivity in patients with resected stage IIB, IIC, III, or IV melanoma vaccinated with tyrosinase, gp100, and MART-1 peptides emulsified with Montanide ISA-51 with interleukin-12 and either alum adjuvant or sargramostim (GM-CSF).

OUTLINE: This is a randomized study. Patients are stratified according to disease stage (cutaneous stage IIB, IIC, III, and IV vs ocular and mucosal stage III and IV). Patients are randomized to 1 of 3 treatment arms.

• Arm I: Patients receive vaccine with tyrosinase:368-376 (370D)/gp100:209-217 (210M)/MART-1:26-27 (27L) peptides emulsified with Montanide ISA-51 (ISA-51), low-dose interleukin-12 (IL-12) subcutaneously (SC), and alum adjuvant SC on day 1 of weeks 1, 3, 5, 7, 11, 15, 19, 27, and 53.
• Arm II: Patients receive peptide vaccine emulsified with ISA-51, high-dose IL-12 SC, and alum adjuvant SC on day 1 of weeks 1, 3, 5, 7, 11, 15, 19, 27, and 53.
• Arm III: Patients receive peptide vaccine emulsified with ISA-51 on day 1 and low-dose IL-12 SC and sargramostim (GM-CSF) SC on days 1-5 of weeks 1, 3, 5, 7, 11, 15, 19, 27, and 53.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 60 patients (20 per treatment arm) will be accrued for this study within 3 years.

Conditions

Intraocular Melanoma; Melanoma (Skin)

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

MART-1 antigen

Intervention Type: BIOLOGICAL

gp100 antigen

Intervention Type: BIOLOGICAL

incomplete Freund's adjuvant

Intervention Type: BIOLOGICAL

recombinant interleukin-12

Intervention Type: BIOLOGICAL

sargramostim

Intervention Type: BIOLOGICAL

tyrosinase peptide

Intervention Type: BIOLOGICAL

alum adjuvant

Intervention Type: DRUG

adjuvant therapy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,000/mm^3
• Granulocyte count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3
• Hemoglobin at least 9.0 g/dL
• No bleeding disorder

Hepatic:

• Bilirubin no greater than 2.0 mg/dL
• SGOT/SGPT no greater than 2.5 times normal
• No coagulation disorder
• Hepatitis surface antigen B negative
• Hepatitis C negative

Renal:

• Creatinine no greater than 2.0 mg/dL

Cardiovascular:

• No major cardiovascular illness

Pulmonary:

• No major respiratory illness

Immunologic:

• No prior uveitis
• No prior autoimmune inflammatory eye disease
• No immune hemolytic anemia
• No other active autoimmune disease

Other:

• HIV negative
• No major gastrointestinal illness
• No other malignancy within the past 5 years except squamous cell skin cancer or carcinoma in situ of the cervix curatively treated at least 30 days ago
• No major systemic infection (e.g., pneumonia or sepsis)
• No other major medical illness
• No prior allergic reaction to Montanide ISA-51 or alum adjuvant
• No requirement for steroid therapy
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• See Disease Characteristics
• No prior tyrosinase:368-376 (370D), gp100:209-217 (210M), or MART-1:26-35 (27L) peptides

Chemotherapy:

• At least 1 month since prior adjuvant chemotherapy for this disease
• No concurrent adjuvant chemotherapy

Endocrine therapy:

• No concurrent steroids

Radiotherapy:

• At least 1 month since prior radiotherapy for this disease
• No concurrent radiotherapy

Surgery:

• See Disease Characteristics

Other:

• At least 1 month since other prior therapy, including adjuvant therapy, for this disease
• No other concurrent therapy, including adjuvant 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 and Hospital

Los Angeles, California, United States

Countries

United States

Other Identifiers

LAC-USC-10M011

Identifier Type: -

Identifier Source: secondary_id

LAC-USC-IRB-013030

Identifier Type: -

Identifier Source: secondary_id

NCI-5506

Identifier Type: -

Identifier Source: secondary_id

CDR0000069220 (10M-01-1)

Identifier Type: -

Identifier Source: org_study_id