Vaccine Therapy in Treating Patients With Metastatic Cancer

NCT00021164 | Completed Phase 2

• 3 other identifiers: CDR0000068756NCI-01-C-0176NCI-4970
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

stage IV melanoma; recurrent melanoma; unspecified adult solid tumor, protocol specific

Interventions

aldesleukin BIOLOGICAL

incomplete Freund's adjuvant BIOLOGICAL

telomerase: 540-548 peptide vaccine BIOLOGICAL

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

aldesleukin; incomplete Freund's adjuvant

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Steven A. Rosenberg, MD, PhD

  NCI - Surgery Branch

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: July 11, 2001
• First Posted: January 27, 2003
• Study Start: May 1, 2001
• Study Completion: May 1, 2004
• Last Updated: June 19, 2013

Record last verified: 2004-04

Locations

US (1)