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Sponsors and Collaborators: |
NCI - Center for Cancer Research-Medical Oncology National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00079144 |
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Treating a person's lymphocytes in the laboratory and reinfusing them may replace immune cells destroyed by chemotherapy. Vaccines made from peptides may make the body build an immune response to kill tumor cells. Giving a vaccine with Montanide ISA-51 may cause a stronger immune response and kill more tumor cells. Interleukin-2 may stimulate a person's lymphocytes to kill tumor cells.
PURPOSE: This phase II trial is studying how well lymphocyte-depleting nonmyeloablative (not damaging to bone marrow) chemotherapy followed by autologous lymphocyte infusion, peptide vaccine plus Montanide ISA-51, and interleukin-2 works in treating patients with metastatic melanoma.
Condition | Intervention | Phase |
Melanoma (Skin) |
Drug: NY-ESO-1 peptide vaccine Drug: aldesleukin Drug: cyclophosphamide Drug: filgrastim Drug: fludarabine phosphate Drug: incomplete Freund's adjuvant Drug: therapeutic autologous lymphocytes |
Phase II |
MedlinePlus related topics: | Cancer Melanoma |
Drug Information available for: | Cyclophosphamide Filgrastim Fludarabine Fludarabine monophosphate Aldesleukin Interleukin-2 Freund's adjuvant Montanide ISA 51 |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Treatment Of Patients With Metastatic Melanoma Using Nonmyeloablative But Lymphocyte Depleting Regimen Followed By The Administration Of In Vitro Sensitized Lymphocytes Reactive With ESO-1 Antigen |
Study Start Date: | January 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are stratified according to type of lymphocyte infusion (ESO-1-reactive tumor-infiltrating lymphocytes [TIL] vs ESO-1 reactive peripheral blood lymphocytes [PBL]).
NOTE: *Day 0 is 1-4 days after the last dose of fludarabine.
Patients achieving stable disease or partial response may receive up to 1 retreatment course. Patients with progressive disease after infusion of PBL may receive retreatment with TIL, if available.
Patients are followed at 4-5 weeks, every 3-4 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 24-74 patients (12-37 per stratum) will be accrued for this study within 2-3 years.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Normal cardiac stress test required for the following conditions:
Pulmonary
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Maryland | |||||
NCI - Center for Cancer Research | |||||
Bethesda, Maryland, United States, 20892 | |||||
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |||||
Bethesda, Maryland, United States, 20892-1182 |
NCI - Center for Cancer Research-Medical Oncology |
National Cancer Institute (NCI) |
Study Chair: | Steven A. Rosenberg, MD, PhD | NCI - Surgery Branch |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000354491, NCI-04-C-0104, NCI-6233 |
First Received: | March 8, 2004 |
Last Updated: | October 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00079144 |
Health Authority: | United States: Federal Government |
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