Lymphocyte-Depleting Nonmyeloablative Preparative Chemotherapy Followed By Autologous Lymphocyte Infusion, Peptide Vaccine Plus Montanide ISA-51, and Interleukin-2 in Treating Patients With Metastatic Melanoma

NCT00079144 | Completed Phase 2

• 3 other identifiers: CDR0000354491NCI-04-C-0104NCI-6233
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Treating a person's lymphocytes in the laboratory and reinfusing them may replace immune cells destroyed by chemotherapy. Vaccines made from peptides may make the body build an immune response to kill tumor cells. Giving a vaccine with Montanide ISA-51 may cause a stronger immune response and kill more tumor cells. Interleukin-2 may stimulate a person's lymphocytes to kill tumor cells. PURPOSE: This phase II trial is studying how well lymphocyte-depleting nonmyeloablative (not damaging to bone marrow) chemotherapy followed by autologous lymphocyte infusion, peptide vaccine plus Montanide ISA-51, and interleukin-2 works in treating patients with metastatic melanoma.

Conditions

Melanoma (Skin)

Keywords

recurrent melanoma; stage IV melanoma

Outcome Measures

Primary Outcomes (1)

• Clinical tumor regression

Secondary Outcomes (2)

• Survival of infused lymphocytes

• Long-term immune status

Interventions

NY-ESO-1 peptide vaccine BIOLOGICAL

aldesleukin BIOLOGICAL

filgrastim BIOLOGICAL

incomplete Freund's adjuvant BIOLOGICAL

therapeutic autologous lymphocytes BIOLOGICAL

cyclophosphamide DRUG

fludarabine phosphate DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Diagnosis of metastatic melanoma that is refractory to standard therapy (including high-dose interleukin-2) * Measurable disease * HLA-A\*0201 positive * Epstein-Barr virus positive * ESO-1-expressing disease by reverse transcription polymerase chain reaction amplified tissue OR presence of ESO-1 serum antibody PATIENT CHARACTERISTICS: Age * 16 and over Performance status * ECOG 0-1 Life expectancy * More than 3 months Hematopoietic * Absolute neutrophil count \> 1,000/mm\^3 * Platelet count \> 100,000/mm\^3 * Hemoglobin \> 8.0 g/dL Hepatic * Hepatitis B surface antigen negative * Hepatitis C antibody negative * AST and ALT \< 3 times upper limit of normal * Bilirubin ≤ 2.0 mg/dL (\< 3.0 mg/dL for patients with Gilbert's syndrome) * No coagulation disorders Renal * Creatinine ≤ 2.0 mg/dL Cardiovascular * No prior myocardial infarction * No major cardiovascular illness by stress thallium or comparable test * No cardiac arrhythmias * LVEF ≥ 45% * Normal cardiac stress test required for the following conditions: * Prior EKG abnormalities * Symptoms of cardiac ischemia * Arrhythmias * Age 50 and over Pulmonary * FEV\_1 \> 60% of predicted (for patients with a prolonged history of cigarette smoking or symptoms of respiratory dysfunction) * No obstructive or restrictive pulmonary disease * No other major respiratory illness Immunologic * HIV negative * No active systemic infection * No opportunistic infection * No major immune system illness * No form of primary or secondary immunodeficiency * No known hypersensitivity to study agents Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 4 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * Prior ESO-1-based vaccination allowed Chemotherapy * At least 6 weeks since prior nitrosoureas and recovered Endocrine therapy * No concurrent systemic steroid therapy Radiotherapy * Recovered from prior radiotherapy Surgery * Not specified Other * At least 4 weeks since prior systemic therapy

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 (2)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

NCI - Center for Cancer Research

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

aldesleukin; Filgrastim; incomplete Freund's adjuvant; Cyclophosphamide; fludarabine phosphate

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

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Steven A. Rosenberg, MD, PhD

  NCI - Surgery Branch

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: March 8, 2004
• First Posted: March 10, 2004
• Study Start: January 1, 2004
• Study Completion: August 1, 2005
• Last Updated: June 19, 2013

Record last verified: 2005-05

Locations

US (2)