Status:
COMPLETED
Gene-Modified White Blood Cells Followed By Interleukin-2 and Vaccine Therapy in Treating Patients With Metastatic Melanoma
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Melanoma (Skin)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 pers...
Detailed Description
OBJECTIVES: Primary * Determine, preliminarily, any clinical tumor regression in lymphodepleted patients with metastatic melanoma treated with fowlpox gp100 antigen immunization and antitumor antige...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2008
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00085462
Start Date
May 1 2004
End Date
September 1 2008
Last Update
June 22 2012
Active Locations (2)
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1
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182
2
NCI - Surgery Branch
Bethesda, Maryland, United States, 20892-1201