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| Tracking Information | |||||
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| First Received Date ICMJE | March 8, 2002 | ||||
| Last Updated Date | February 6, 2009 | ||||
| Start Date ICMJE | January 2002 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00031564 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Vaccine Therapy and Interleukin-2 in Treating Patients With Stage IV Kidney Cancer | ||||
| Official Title ICMJE | Phase II Study of a B7-1 Gene-Modified Autologous Tumor Cell Vaccine and Systemic IL-2 for Patients With Stage IV Renal Cell Carcinoma | ||||
| Brief Summary | RATIONALE: Vaccines made by inserting a laboratory-treated gene into a person's tumor cells may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining vaccine therapy with interleukin-2 may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with interleukin-2 in treating patients who have stage IV kidney cancer. |
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| Detailed Description | OBJECTIVES:
OUTLINE: Tumor tissue for vaccine preparation is obtained when patients undergo palliative surgical resection of primary tumor or therapeutic resection of metastasis. At approximately 3-6 weeks after surgery, patients receive B7-1 gene-modified autologous tumor cell vaccine subcutaneously (SC) once on days 1, 29, and 57. At 6 weeks after the first vaccination, patients receive interleukin-2 (IL-2) SC five days a week for 6 weeks (days 43-82). Patients with stable or responding disease after day 106 may receive additional vaccinations in the absence of disease progression or unacceptable toxicity. Patients are followed at 3 weeks after the last dose of IL-2. PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE | Kidney Cancer | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | Fishman M, Hunter TB, Soliman H, Thompson P, Dunn M, Smilee R, Farmelo MJ, Noyes DR, Mahany JJ, Lee JH, Cantor A, Messina J, Seigne J, Pow-Sang J, Janssen W, Antonia SJ. Phase II Trial of B7-1 (CD-86) Transduced, Cultured Autologous Tumor Cell Vaccine Plus Subcutaneous Interleukin-2 for Treatment of Stage IV Renal Cell Carcinoma. J Immunother (1997). 2008 Jan;31(1):72-80. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00031564 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000068260, MCC-12207, MCC-IRB-5620, NCI-5090, NCI-G00-1872 | ||||
| Study Sponsor ICMJE | H. Lee Moffitt Cancer Center and Research Institute | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | April 2004 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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