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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00354055 |
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Aldesleukin may stimulate natural killer cells to kill tumor cells. Giving chemotherapy followed by autologous natural killer cells and aldesleukin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving chemotherapy followed by autologous natural killer cells and aldesleukin works in treating patients with metastatic melanoma or kidney cancer.
Condition | Intervention | Phase |
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Kidney Cancer Melanoma (Skin) |
Biological: aldesleukin Biological: therapeutic autologous lymphocytes Drug: cyclophosphamide Drug: fludarabine phosphate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study in Metastatic Melanoma or Kidney Cancer Using Autologous Natural Killer Cells Plus Aldesleukin (IL-2) Following a Lymphodepleting Chemotherapy |
Estimated Enrollment: | 58 |
Study Start Date: | May 2006 |
Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are stratified according to disease (melanoma vs renal cell cancer).
Patients who achieve partial or complete response and then develop progressive disease may receive 1 additional course of therapy as above.
After completion of study therapy, patients are followed periodically.
PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed melanoma or renal cell cancer
PATIENT CHARACTERISTICS:
No known toxicity during prior aldesleukin administration that would preclude redosing with aldesleukin, including any of the following:
No other major medical illness of the cardiovascular, respiratory, or immune system, as evidenced by any of the following:
PRIOR CONCURRENT THERAPY:
United States, Maryland | |
NCI - Surgery Branch | |
Bethesda, Maryland, United States, 20892-1201 | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | |
Bethesda, Maryland, United States, 20892-1182 |
Principal Investigator: | Steven A. Rosenberg, MD, PhD | NCI - Surgery Branch |
Responsible Party: | NCI - Surgery Branch ( Steven A. Rosenberg ) |
Study ID Numbers: | CDR0000486918, NCI-06-C-0169, NCI-P6950 |
Study First Received: | July 19, 2006 |
Last Updated: | April 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00354055 History of Changes |
Health Authority: | United States: Food and Drug Administration |
recurrent melanoma stage IV melanoma stage IV renal cell cancer stage IV melanoma |
Antimetabolites Anti-Infective Agents Urinary Tract Neoplasm Immunologic Factors Urogenital Neoplasms Cyclophosphamide Urologic Neoplasms Melanoma Renal Cancer Anti-Retroviral Agents Urologic Diseases Kidney Neoplasms Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Neuroepithelioma |
Kidney Diseases Alkylating Agents Kidney Cancer Anti-HIV Agents Fludarabine monophosphate Antiviral Agents Immunosuppressive Agents Recurrence Neuroendocrine Tumors Carcinoma Neuroectodermal Tumors Aldesleukin Carcinoma, Renal Cell Antineoplastic Agents, Alkylating Nevus |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Urogenital Neoplasms Cyclophosphamide Urologic Neoplasms Melanoma Neoplasms by Site Anti-Retroviral Agents Urologic Diseases |
Kidney Neoplasms Therapeutic Uses Neoplasms, Germ Cell and Embryonal Nevi and Melanomas Kidney Diseases Alkylating Agents Anti-HIV Agents Neoplasms by Histologic Type Fludarabine monophosphate Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Carcinoma Neuroendocrine Tumors Neuroectodermal Tumors |