Status:
TERMINATED
Therapeutic Autologous Lymphocytes, Aldesleukin, and Denileukin Diftitox in Treating Patients With Stage III-IV Melanoma
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Recurrent Melanoma
Stage III Melanoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: White blood cells that have been treated in a laboratory may be able to kill tumor cells in patients with melanoma. Aldesleukin and denileukin diftitox may stimulate the white blood cells t...
Detailed Description
PRIMARY OBJECTIVES: I. Assess the safety of cellular adoptive immunotherapy in melanoma patients using autologous CD8+ antigen-specific T-cell clones following CD25 lymphodepletion. II. Determine th...
Eligibility Criteria
Inclusion
- Histopathological documentation of melanoma
- Expression of human leukocyte antigen (HLA)-A2 or B44 as determined by HLA typing lab
- Patients whose tumor expresses targeted antigen and restricting allele against which CD8 T cell clones can be generated
- Karnofsky Performance status of at least 80% and an expected survival of greater than 6 months
- Bi-dimensionally measurable disease by palpation on clinical exam, or radiographic imaging (X-ray, computed tomography \[CT\] scan)
- Normal cardiac stress test (treadmill, echocardiogram, or myocardial perfusion scan) within 182 days prior to enrollment is required of patients with a history of cardiac disease
- Pulse \> 45 or \< 120
- Weight \>= 45 kg
- Temperature =\< 38C (\< 100.4 F)
- White blood cells (WBC) \>= 3,000
- Hematocrit (HCT) \>= 30%
- Platelets \>= 100,000
- Patients must be willing and able to discontinue the use of all antihypertensive medications 24 hours prior to and during IL2 therapy
Exclusion
- Pregnant women, nursing mothers, or women of reproductive ability who are unwilling to use effective contraception or abstinence
- Serum creatinine \> 1.6mg/dL
- Creatinine clearance \< 75 ml/min
- Aspartate aminotransferase (AST) \> 2.5 x upper limit of normal
- Alanine aminotransferase (ALT) \> 2.5 x upper limit of normal
- Bilirubin \> 1.6 or international normalized ratio (INR) \> 1.5 due to hepatic dysfunction
- Albumin \< 3.0g/dL
- Clinically significant pulmonary dysfunction, as determined by medical history and physical exam; patients so identified will undergo pulmonary functions testing and those with Forced expiratory volume in one second (FEV1) \< 80% predicted or diffusing capacity of the lung for carbon monoxide (DLco) (corr for hemoglobin \[Hgb\]) \< 75% will be excluded
- Significant cardiovascular abnormalities as defined by any one of the following: congestive heart failure, symptoms of coronary artery disease
- Symptomatic central nervous system (CNS) metastases greater than 1 cm at time of therapy; patients with 1-2 asymptomatic, less than 1cm brain/CNS metastases without significant edema may be considered for treatment
- Patients with active infections or oral temperature \> 38.2 C within 48 hours of study entry or systemic infection requiring chronic maintenance or suppressive therapy
- Chemotherapeutic agents (standard or experimental), radiation therapy, or other immunosuppressive therapies less than 3 weeks prior to T cell therapy)
- Concurrent treatment with steroids
- Patients must not be receiving any other experimental drugs within 3 weeks of the initiation of the protocol and must have recovered from all side effects of such therapy
- The following agents are not allowed while on study: systemic corticosteroids (except as outlined for management of toxicity of nontransduced CTL), immunotherapy (for example, interleukins, interferons, melanoma vaccines, intravenous immunoglobulin, expanded polyclonal TIL or LAK therapy), pentoxifylline, or other investigational agents
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00945269
Start Date
July 1 2009
End Date
January 1 2011
Last Update
November 15 2022
Active Locations (1)
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1
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109