Gene-Modified White Blood Cells Followed By Interleukin-2 and Vaccine Therapy in Treating Patients With Metastatic Melanoma

NCT00085462 | Completed Phase 1

• 4 other identifiers: 04018104-C-0181NCI-6470CDR0000370798
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Inserting a gene that has been created in the laboratory into a person's white blood cells may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Vaccines may make the body build an immune response to kill tumor cells. Combining gene-modified white blood cell infusions with interleukin-2 and vaccine therapy may kill more tumor cells. PURPOSE: This phase I trial is studying how well giving gene-modified white blood cells when given together with interleukin-2 and vaccine therapy works in treating patients with metastatic melanoma.

Conditions

Melanoma (Skin)

Keywords

recurrent melanoma; stage IV melanoma

Interventions

aldesleukin BIOLOGICAL

filgrastim BIOLOGICAL

gp100-fowlpox vaccine BIOLOGICAL

therapeutic autologous lymphocytes BIOLOGICAL

therapeutic tumor infiltrating lymphocytes BIOLOGICAL

cyclophosphamide DRUG

fludarabine phosphate DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Diagnosis of melanoma * Metastatic disease * Measurable disease * Refractory to standard therapy, including high-dose interleukin-2 therapy * HLA-A\*0201 positive * Progressive disease during prior immunization to melanoma antigens OR prior treatment with anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) cellular therapy with or without myeloablation allowed provided toxicity resolved to ≤ grade 2 (except vitiligo) AND patient does not require systemic steroids * No brain metastases PATIENT CHARACTERISTICS: Age * 18 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 * Lymphocyte count \> 500/mm\^3 * WBC \> 3,000/mm\^3 * No coagulation disorders Hepatic * AST and ALT \< 3 times upper limit of normal (ULN) * Bilirubin ≤ 2.0 mg/dL (3.0 mg/dL in patients with Gilbert's syndrome) * Hepatitis B surface antigen negative * Hepatitis C antibody negative (unless antigen negative) Renal * Creatinine ≤ 1.6 mg/dL Cardiovascular * LVEF ≥ 45% by cardiac stress test * No LVEF \< 45% in patients ≥ 50 years of age * No myocardial infarction * No cardiac arrhythmias * No symptomatic cardiac ischemia * No prior EKG abnormalities * No other major cardiovascular illness Pulmonary * FEV\_1 ≥ 60% of predicted AND no obstructive or restrictive pulmonary disease * No symptoms of respiratory dysfunction * No other major respiratory illness Immunologic * HIV negative * Epstein-Barr virus positive * No active systemic infections (including opportunistic infections) * No form of primary (e.g., autoimmune colitis or Crohn's disease) or secondary immunodeficiency (due to chemotherapy or radiotherapy) * No prior severe immediate hypersensitivity reaction to any of the study agents including eggs * No other major illness of the immune system Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 4 month after study participation * Willing to complete a durable power of attorney (DPA) PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * More than 6 weeks since prior MDX-010 Chemotherapy * Not specified Endocrine therapy * See Disease Characteristics * No concurrent systemic steroid therapy Radiotherapy * Not specified Surgery * Not specified Other * More than 4 weeks since other prior systemic therapy and recovered

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

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, 20892-1182, United States

Location

NCI - Surgery Branch

Bethesda, Maryland, 20892-1201, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

aldesleukin; Filgrastim; 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 10, 2004
• First Posted: June 11, 2004
• Study Start: May 1, 2004
• Primary Completion: May 1, 2007
• Study Completion: September 1, 2008
• Last Updated: June 22, 2012

Record last verified: 2012-06

Locations

US (2)