NCT00085462CompletedPhase 1
Treatment of Patients With Metastatic Melanoma by Lymphodepleting Conditioning Followed by Infusion of TCR-Gene Engineered Lymphocytes and Subsequent Fowlpox gp100 Vaccination
National Institutes of Health Clinical Center (CC)4 sites in 1 country61 target enrollmentStarted: May 1, 2004Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 61
- Locations
- 4
Study Overview
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.
Detailed Description
OBJECTIVES:
Primary
- Determine, preliminarily, any clinical tumor regression in lymphodepleted patients with metastatic melanoma treated with fowlpox gp100 antigen immunization and antitumor antigen T-cell receptor (TCR)-engineered tumor infiltrating lymphocytes or CD8+ autologous peripheral blood lymphocytes followed by interleukin-2.
Secondary
- Determine the in vivo survival of TCR gene-engineered cells in patients treated with this regimen.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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:
- •18 and over
- •Performance status
- •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
- •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)
- •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
- •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
- •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
- +10 more not shown
Exclusion Criteria
- Not provided
Investigators
Study Sites (4)
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