Single Patient Study to Evaluate Cellular Adoptive Immunotherapy Using Autologous Lymphocytes Following Cyclophosphamide Conditioning for a Single Patient With Metastatic Melanoma
18 Years
75 Years
Both
Melanoma (Skin)
Trial Information
Single Patient Study to Evaluate Cellular Adoptive Immunotherapy Using Autologous Lymphocytes Following Cyclophosphamide Conditioning for a Single Patient With Metastatic Melanoma
OBJECTIVES:
Primary
- Assess the safety and toxicity of cellular adoptive immunotherapy with autologous
tumor-infiltrating lymphocytes (TIL) following cyclophosphamide conditioning and
post-infusion aldesleukin (IL-2) in patients with metastatic melanoma.
- Assess the duration of in vivo persistence of adoptively transferred lymphocytes.
Secondary
- Evaluate the antitumor effect of adoptively transferred autologous TIL following
cyclophosphamide conditioning and post-infusion IL-2 in these patients.
OUTLINE: Patients receive cyclophosphamide IV on days -3 and -2 and autologous
tumor-infiltrating lymphocytes (TIL) IV on day 0. Beginning 6 hours after TIL infusion,
patients receive high-dose aldesleukin (IL-2) IV three times daily on days 0-5 (for up to 14
doses) OR low-dose IL-2 subcutaneously twice daily on days 0-14 (for up to 28 doses).
Patients may then receive two additional courses of TILs and low-dose IL-2 (with or without
cyclophosphamide), if indicated.
After completion of study treatment, patients are followed up periodically.
Inclusion Criteria
Inclusion Criteria
- Histopathological documentation of melanoma concurrent with the diagnosis of
metastatic disease.
- 18 to 75 years of age and able to tolerate high-dose cyclophosphamide
- Bi-dimensionally measurable disease by palpation on clinical exam, or radiographic
imaging (X-ray, CT scan).
- For patients receiving HD-IL-2, normal cardiac stress test within 182 days prior to
enrollment is required of all patients over 50 years old or those with an abnormal
ECG, any history of cardiac disease, a family history of cardiac disease,
hypercholesterolemia or hypertension.
- For leukapheresis, patients must meet the following criteria (any exceptions to this
will require prior approval by the Apheresis director and Principal Investigator):
- Pulse: >45 or < 120
- Weight: >45 kg
- Temperature: <38C (<100.4 F)
- WBC: >3,000
- HCT: >30%
- Platelets: >100,000
- ADDITIONAL INCLUSION CRITERIA FOR T CELL INFUSION
Exclusion Criteria
- 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 EKG requiring drug therapy
- ejection fraction < 50 % (echocardiogram or MUGA)
- Patients with active infections or oral temperature > 38.2 C within 72 hours of study
entry or systemic infection requiring chronic maintenance or suppressive therapy.
Type of Study:
Expanded Access
Study Design:
N/A
Principal Investigator
Cassian Yee, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Fred Hutchinson Cancer Research Center
Authority:
United States: Food and Drug Administration
Study ID:
2355.00
NCT ID:
NCT01005537
Start Date:
June 2009
Completion Date:
Related Keywords:
- Melanoma (Skin)
- stage IV melanoma
- Melanoma
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