Status:
TERMINATED
Gene-Modified Lymphocytes, High-Dose Aldesleukin, and Vaccine Therapy in Treating Patients With Progressive or Recurrent Metastatic Cancer
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Kidney Cancer
Melanoma (Skin)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Gene-modified lymphocytes may stimulate the immune system in different ways and stop tumor cells from growing. High-dose aldesleukin may stimulate lymphocytes to kill tumor cells. Vaccines ...
Detailed Description
OBJECTIVES: Primary * Determine if the administration of anti-p53 T-cell receptor (TCR) gene-engineered peripheral blood lymphocytes, high-dose aldesleukin, and adenovirus p53 dendritic cell (DC) va...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of metastatic cancer
- Tumor overexpresses p53 as assessed by immunohistochemistry (i.e., ≥ 5% tumor cells stain positive for p53)
- Biopsy must be available to evaluate p53 expression
- Human leukocyte antigens 0201 (HLA-A\*0201) positive
- Progressive or recurrent disease after prior standard therapy for metastatic disease
- Patients with melanoma or renal cell cancer must have previously received aldesleukin
- Patients with other histologies, not including hematologic malignancies, must have previously received first-line and second-line or higher systemic standard therapy (or effective salvage chemotherapy regimens)
- PATIENT CHARACTERISTICS:
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Life expectancy \> 3 months
- Absolute neutrophil count \> 1,000/mm\^3
- White blood cell (WBC) \> 3,000/mm\^3
- Platelet count \> 100,000/mm\^3
- Hemoglobin \> 8.0 g/dL
- Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 2.5 times upper limit of normal
- Serum creatinine ≤ 1.6 mg/dL
- Total bilirubin ≤ 2.0 mg/dL (\< 3.0 mg/dL in patients with Gilbert's syndrome)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 4 months after completion of study treatment
- Patients who have previously received ipilimumab or ticilimumab must have a normal colonoscopy with normal colonic biopsies
- Human immunodeficiency virus (HIV) antibody negative
- Hepatitis B antigen and hepatitis C antibody negative (unless antigen negative)
- No primary immunodeficiency (e.g., severe combined immunodeficiency disease)
- No active systemic infections
- No history of severe immediate hypersensitivity reaction to any of the agents used in this study
- No coagulation disorders
- No myocardial infarction or cardiac arrhythmias
- No history of coronary revascularization
- No obstructive or restrictive pulmonary disease
- No contraindications for high-dose aldesleukin administration
- Left ventricular ejection fraction (LVEF) ≥ 45% in patients meeting any of the following criteria:
- History of ischemic heart disease,
- chest pain,
- or clinically significant atrial and/or ventricular arrhythmias including, but not limited to, atrial fibrillation,
- ventricular tachycardia,
- or second- or third-degree heart block
- At least 60 years of age
- Forced expiratory volume 1 (FEV\_1) \> 60% predicted in patients meeting any of the following criteria:
- Prolonged history of cigarette smoking (\> 20 pack/year within the past 2 years)
- Symptoms of respiratory dysfunction
- No other major medical illness of the cardiovascular,
- respiratory,
- or immune system
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from prior therapy
- More than 4 weeks since prior and no concurrent systemic steroid therapy
- More than 4 weeks since other prior systemic therapy
- More than 6 weeks since prior ipilimumab
Exclusion
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00704938
Start Date
June 1 2008
End Date
August 1 2009
Last Update
October 28 2015
Active Locations (1)
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1
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182