Status:
COMPLETED
Laboratory-Treated T Cells and Ipilimumab in Treating Patients With Metastatic Melanoma
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Recurrent Melanoma
Stage IV Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This phase I/II trial is studying the side effects of giving laboratory-treated T cells and ipilimumab together to see how well they work in treating patients with metastatic melanoma. Treating a pati...
Detailed Description
PRIMARY OBJECTIVES: I. Evaluate the safety and efficacy of adoptively transferred cytotoxic lymphocytes (CTL) targeting melanoma tumors combined with anti-CTLA4. II. Evaluate the influence of anti-C...
Eligibility Criteria
Inclusion
- Histopathologic documentation of melanoma concurrent with the diagnosis of metastatic disease
- Expression of human leukocyte antigen (HLA)-A2
- Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of 0-1
- Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized; suggested precautions should be used to minimize the risk or pregnancy for at least 1 month before start of therapy, and while women are on study for up to 3 months after T cell infusion, and at least 8 weeks after the study drug is stopped; WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal
- Men must be willing and able to use an acceptable method of birth control, for at least 3 months after completion of the study, if their sexual partners are WOCBP
- Willing and able to give informed consent
- Adequate venous access-consider peripherally inserted central catheter (PICC) or central line
- Bi-dimensionally measurable disease by palpation on clinical exam, or radiographic imaging (X-ray, computed tomography \[CT\] scan)
- At least 4 weeks must have elapsed since the last chemotherapy, radiotherapy or major surgery; at least 6 weeks for nitrosoureas, mitomycin C and liposomal doxorubicin; if started before T-cell administration, Ipilimumab infusions must be least 21 days apart
- Toxicity related to prior therapy must either have returned to =\< grade 1, baseline, or been deemed irreversible
- Persons of reproductive potential must agree to use and utilize an adequate method of contraception throughout treatment and for at least 8 weeks after study drug is stopped
Exclusion
- Patients with active infections or oral temperature \> 38.2 C within 72 hours prior to planned leukapheresis; the procedure may be deferred
- Patients with hematocrit (Hct) \< 30%, white blood cells (WBC) \< 2500/uL and platelets \< 50,000 immediately prior to leukapheresis; the procedure may be deferred
- Any other malignancy from which the patient has been disease-free for less than 5 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix
- White blood cell count (WBC) \< 2000/uL
- Hematocrit (Hct) \< 24% or hemoglobin (Hb) \< 8 g/dL
- Absolute neutrophile count (ANC) \< 1000
- Platelets \< 50,000
- Creatinine \> 3.0 x upper limit normal (ULN)
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \> 2.5 x ULN
- Bilirubin \> 3 x ULN
- Pregnant women, nursing mothers, men or women of reproductive ability who are unwilling to use effective contraception; women of childbearing potential with a positive pregnancy test within 3 days prior to entry
- 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) \< 2.0 L or diffusion capacity of carbon monoxide (DLco) (corr for Hgb) \< 50% will be excluded
- Significant cardiovascular abnormalities as defined by any one of the following:
- Congestive heart failure
- Clinically significant hypotension
- Symptoms of coronary artery disease
- Presence of cardiac arrhythmias on electrocardiogram (EKG) requiring drug therapy
- Ejection fraction \< 50 % (echocardiogram or multi gated acquisition \[MUGA\] scan)
- Active and untreated central nervous system (CNS) metastasis (including metastasis identified during screening magnetic resonance imaging \[MRI\] or contrast CT)
- Autoimmune disease: Patients with a history of Inflammatory Bowel Disease are excluded from this study, as are patients with a history of autoimmune disease (e.g. systemic lupus erythematosus, vasculitis, infiltrating lung disease) whose possible progression during treatment would be considered by the Investigator to be unacceptable
- Any underlying medical or psychiatric condition, which in the opinion of the Investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent diarrhea
- Positive screening tests for human immunodeficiency virus (HIV), hepatitis (Hep) B, and Hep C; if positive results are not indicative of true active or chronic infection, the patient can be treated
- Steroids are not permitted 3 days prior to T cell infusion and concurrently during therapy
- No prisoners or children will be enrolled on this study
- Any non-oncology vaccine therapy used for the prevention of infectious disease within 1 month before or after any ipilimumab dose
- Patients may not be on any other treatments for their cancer aside from those included in the protocol; patients may not undergo another form of treatment concurrently with this study
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00871481
Start Date
February 1 2009
End Date
October 1 2013
Last Update
April 19 2017
Active Locations (1)
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1
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109