Vaccine Therapy in Treating Patients With Metastatic Cancer

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title:

Immunization of HLA-A*0201 Patients With Metastatic Cancer Using a Peptide Epitope From the Telomerase Antigen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00021164
• Other study ID #: CDR0000068756
• Secondary ID: NCI-01-C-0176NCI
• Status: Completed
• Phase: Phase 2
• First received: July 11, 2001
• Last updated: June 17, 2013
• Start date: May 2001
• Est. completion date: May 2004

Study information

• Verified date: April 2004
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00016640

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: May 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma (Skin)
• Neoplasm Metastasis
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Biological:
• aldesleukin

• incomplete Freund's adjuvant

• telomerase: 540-548 peptide vaccine

Locations

Country	Name	City	State
United States	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,