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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 |
---|---|---|
Kidney Cancer Melanoma (Skin) |
Drug: aldesleukin Drug: cyclophosphamide Drug: fludarabine phosphate Drug: therapeutic autologous lymphocytes |
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 |
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 | Recruiting |
Bethesda, Maryland, United States, 20892-1201 | |
Contact: Steven A. Rosenberg, MD, PhD 866-820-4505 sar@nih.gov | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
Bethesda, Maryland, United States, 20892-1182 | |
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 |
Principal Investigator: | Steven A. Rosenberg, MD, PhD | NCI - Surgery Branch |
Study ID Numbers: | CDR0000486918, NCI-06-C-0169, NCI-P6950 |
Study First Received: | July 19, 2006 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00354055 |
Health Authority: | Unspecified |
recurrent melanoma stage IV melanoma stage IV renal cell cancer stage IV melanoma |
Urogenital Neoplasms Fludarabine monophosphate Cyclophosphamide Renal cancer Kidney cancer Urologic Neoplasms Recurrence Melanoma Carcinoma Neuroendocrine Tumors Neuroectodermal Tumors Aldesleukin |
Urologic Diseases Kidney Neoplasms Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Carcinoma, Renal Cell Neuroepithelioma Fludarabine Nevus Kidney Diseases Adenocarcinoma Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
Antimetabolites Anti-Infective Agents Anti-HIV Agents Antimetabolites, Antineoplastic Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Antiviral Agents |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Anti-Retroviral Agents Therapeutic Uses Myeloablative Agonists Nevi and Melanomas Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |