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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00704938 |
RATIONALE: Gene-modified lymphocytes may stimulate the immune system in different ways and stop tumor cells from growing. High-dose aldesleukin may stimulate lymphocytes to kill tumor cells. Vaccines made from a gene modified virus and a person's dendritic cells may help the body build an effective immune response to kill tumor cells. Giving gene-modified lymphocytes together with high-dose aldesleukin and vaccine therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gene-modified lymphocytes together with high-dose aldesleukin and vaccine therapy works in treating patients with progressive or recurrent metastatic cancer.
Condition | Intervention | Phase |
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Kidney Cancer Melanoma (Skin) Unspecified Adult Solid Tumor, Protocol Specific |
Biological: aldesleukin Biological: anti-p53 T-cell receptor-transduced peripheral blood lymphocytes Biological: autologous dendritic cell-adenovirus p53 vaccine Biological: filgrastim Drug: cyclophosphamide Drug: fludarabine phosphate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled |
Official Title: | Phase II Study of Metastatic Cancer That Overexpresses p53 Using Lymphodepleting Conditioning Followed by Infusion of Anti-P53 TCR-Gene Engineered Lymphocytes and Dendritic Cell Vaccination |
Estimated Enrollment: | 82 |
Study Start Date: | June 2008 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are stratified according to type of metastatic cancer (melanoma or renal cell cancer vs all other cancers).
Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily beginning on day 1 or 2 and continuing until blood counts recover.
Patients may receive one re-treatment course as above (nonmyeloablative preparative regimen, peripheral blood lymphocyte infusion, high-dose aldesleukin, and dendritic cell vaccinations) beginning 6-8 weeks after the last dose of high-dose aldesleukin.
After completion of study treatment, patients are followed periodically for up to 15 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Tumor overexpresses p53 as assessed by immunohistochemistry (i.e., ≥ 5% tumor cells stain positive for p53)
Progressive or recurrent disease after prior standard therapy for metastatic disease
PATIENT CHARACTERISTICS:
LVEF ≥ 45% in patients meeting any of the following criteria:
FEV_1 > 60% predicted in patients meeting any of the following criteria:
PRIOR CONCURRENT THERAPY:
United States, Maryland | |
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 |
Responsible Party: | NCI - Surgery Branch ( Steven A. Rosenberg ) |
Study ID Numbers: | CDR0000598419, NCI-08-C-0155, NCI-P07215 |
Study First Received: | June 24, 2008 |
Last Updated: | April 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00704938 History of Changes |
Health Authority: | Unspecified |
recurrent renal cell cancer stage IV renal cell cancer recurrent melanoma stage IV melanoma unspecified adult solid tumor, protocol specific |
Antimetabolites 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 Neoplasm Metastasis 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 Physiological Effects of Drugs Neoplasms, Nerve Tissue Urogenital Neoplasms Cyclophosphamide Urologic Neoplasms Melanoma Neoplastic Processes Neoplasms by Site Pathologic Processes |
Anti-Retroviral Agents Urologic Diseases Kidney Neoplasms Therapeutic Uses Neoplasms, Germ Cell and Embryonal Neoplasm Metastasis Nevi and Melanomas Kidney Diseases Alkylating Agents Anti-HIV Agents Neoplasms by Histologic Type Fludarabine monophosphate Antiviral Agents Immunosuppressive Agents Pharmacologic Actions |