Vaccine Therapy in Treating Patients With Metastatic Cancer

NCT ID: NCT00021164

Last Updated: 2013-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-05-31
• Study Completion Date: 2004-05-31

Brief Summary

RATIONALE: Vaccines made from a peptide may make the body build an immune response and kill tumor cells.

PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy in treating patients who have metastatic cancer.

Detailed Description

OBJECTIVES:

• Determine whether an immunologic response can be obtained in HLA*0201-expressing patients with metastatic cancer treated with telomerase: 540-548 peptide vaccine emulsified in Montanide ISA-51.
• Determine which vaccine strategy (frequency, schedule, and dosing) is best for future studies in these patients.
• Determine the toxicity of this treatment in these patients.
• Determine whether prior immunization with telomerase: 540-548 peptide vaccine results in increased clinical response to interleukin-2 in patients with melanoma.

OUTLINE: This is a randomized study. Patients are stratified according to disease (metastatic cutaneous melanoma vs other tumor types). Patients are randomized to one of three treatment arms.

• Arm I: Patients receive telomerase: 540-548 peptide vaccine emulsified in Montanide ISA-51 subcutaneously (SC) on day 1 of weeks 1-4 and 7-10. Patients also undergo leukapheresis over 3 hours at baseline and after each course of treatment.
• Arm II: Patients receive telomerase: 540-548 peptide vaccine emulsified in Montanide ISA-51 SC on day 1 of weeks 1, 4, 7, and 10. Patients also undergo leukapheresis over 3 hours at baseline, after the vaccine on week 4, and after each course of treatment.
• Arm III: Patients receive telomerase: 540-548 peptide vaccine emulsified in Montanide ISA-51 SC on days 1-4 of weeks 1, 4, 7, and 10. Patients undergo leukapheresis as in arm II.

Treatment in all arms repeats every 13 weeks for 4-6 courses in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 1 additional course of treatment after achieving CR.

Eligible melanoma patients with progressive disease on vaccine alone on any of the 3 arms may receive interleukin-2 (IL-2) combined with vaccine as in arm II. Beginning the day after each immunization, IL-2 is administered IV over 15 minutes every 8 hours over 4 days on weeks 1, 4, 7, and 10 for a maximum of 12 doses. Patients continuing to experience disease progression on combined vaccine and IL-2 therapy go off study after 2 courses of combined therapy.

Patients are followed at 3 weeks.

PROJECTED ACCRUAL: A total of 90-162 patients (30-54 per treatment arm; 45-81 per stratum) will be accrued for this study within less than 2 years.

Conditions

Melanoma (Skin); Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

aldesleukin

Intervention Type: BIOLOGICAL

incomplete Freund's adjuvant

Intervention Type: BIOLOGICAL

telomerase: 540-548 peptide vaccine

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Presenting with evaluable metastatic cancer

• Refractory to standard treatment OR
• Post-radiation for malignant glioma
• HLA-A*0201 expression

PATIENT CHARACTERISTICS:

Age:

• 16 and over

Performance status:

• ECOG 0-2

Life expectancy:

• More than 3 months

Hematopoietic:

• WBC at least 3,000/mm^3
• Platelet count at least 90,000/mm^3

Hepatic:

• Bilirubin no greater than 1.6 mg/dL
• AST/ALT less than 3 times normal
• Hepatitis B surface antigen negative

Renal:

• Creatinine no greater than 2.0 mg/dL

Cardiovascular:

• No cardiac ischemia by stress thallium or comparable test*
• No prior myocardial infarction*
• No cardiac arrhythmias* NOTE: *Patients receiving interleukin-2 (IL-2) only

Pulmonary:

• No obstructive or restrictive pulmonary disease (patients receiving IL-2 only)

Immunologic:

• HIV negative
• No autoimmune disease or any other known immunodeficiency disease
• No active primary or secondary immunodeficiency

Other:

• No other active major medical illness*
• No active systemic infection
• Not pregnant
• Negative pregnancy test
• Fertile patients must use effective contraception NOTE: *Patients receiving IL-2 only

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior telomerase: 540-548 peptide immunization

Chemotherapy:

• Recovered from prior chemotherapy

Endocrine therapy:

• No requirement for systemic steroid therapy

Radiotherapy:

• See Disease Characteristics
• Recovered from prior radiotherapy

Surgery:

• Not specified

Other:

• At least 3 weeks since prior systemic therapy for cancer

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Principal Investigators

Steven A. Rosenberg, MD, PhD

Role: STUDY_CHAIR

NCI - Surgery Branch

Locations

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, United States

Countries

United States

Other Identifiers

NCI-01-C-0176

Identifier Type: -

Identifier Source: secondary_id

NCI-4970

Identifier Type: -

Identifier Source: secondary_id

CDR0000068756

Identifier Type: -

Identifier Source: org_study_id

NCT00016640

Identifier Type: -

Identifier Source: nct_alias