|
Vaccine Therapy Following Surgery in Treating Patients With Locally Advanced Kidney Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Vaccine Therapy Following Surgery in Treating Patients With Locally Advanced Kidney Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Vaccine Therapy Following Surgery in Treating Patients With Locally Advanced Kidney Cancer Clinical research trials and Vaccine Therapy Following Surgery in Treating Patients With Locally Advanced Kidney Cancer medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Vaccine Therapy Following Surgery in Treating Patients With Locally Advanced Kidney Cancer. Vaccine Therapy Following Surgery in Treating Patients With Locally Advanced Kidney Cancer Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Vaccine Therapy Following Surgery in Treating Patients With Locally Advanced Kidney Cancer clinical trial. Participants frequently obtain the most expert healthcare available for their Vaccine Therapy Following Surgery in Treating Patients With Locally Advanced Kidney Cancer condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "V" Clinical Trials Conditions > Vaccine Therapy Following Surgery in Treating Patients With Locally Advanced Kidney Cancer  Vaccine Therapy Following Surgery in Treating Patients With Locally Advanced Kidney Cancer
Vaccine Therapy Following Surgery in Treating Patients With Locally Advanced Kidney Cancer
For Condition: stage 2 renal cell cancer,stage 3 renal cell cancer
Status: Recruiting
Sponsor(s): Antigenics ,
Synopsis: RATIONALE: Vaccines made from a patient's white blood cells and tumor cells may make the body build an immune response to kill tumor cells. It is not yet known if surgery plus vaccine therapy is more effective than surgery alone for advanced kidney cancer. PURPOSE: Randomizedphase III trial to determine the effectiveness of vaccine therapy following surgery in treating patients who have locally advanced kidney cancer.
Details: OBJECTIVES: - Compare recurrence-free survival of patients with locally advanced renal cell carcinoma at high risk for recurrence treated with adjuvant autologous gp96 heat shock protein-peptide complex (HSPPC-96) vs observation after surgical resection. - Compare the overall survival of patients treated with these regimens. - Determine the safety of HSPCC-96 in these patients. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to histological grade of tumor (1-2 vs 3-4), nodal status (NX or N0 vs N+), and performance status (0 vs 1). All patients undergo complete surgical resection of the tumor. Patients are then randomized to 1 of 2 treatment arms. - Arm I: At 6-8 weeks after surgical resection, patients receive adjuvant autologous gp96 heat shock protein-peptide complex intradermally once weekly for 4 weeks and then once every 2 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. - Arm II: Patients undergo observation after surgical resection. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 50 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of primary intact renal cell carcinoma - Must meet one of the following criteria: - Tumor size at least 5 cm by radiologic exam - Macroscopic nodes - Vena cava thrombus - No distant metastasis - Planned surgical resection with curative intent PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Zubrod 0-1 - ECOG 0-1 - WHO 0-1 Life expectancy: - More than 3 months Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 mg/dL - ALT no greater than 2.5 times upper limit of normal Renal: - Creatinine no greater than 2.3 mg/dL Cardiovascular: - See Disease Characteristics - No New York Heart Association class III or IV heart disease Other: - No active uncontrolled infection - No other serious medical illness requiring hospitalization - No history of primary or secondary immunodeficiency - No other malignancy within the past 5 years except adequately treated cone-biopsied carcinoma in situ of the cervix or basal cell or squamous cell skin cancer - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior immunotherapy for renal cell cancer Chemotherapy: - No prior chemotherapy for renal cell cancer Endocrine therapy: - No prior hormonal therapy for renal cell cancer - No prior or concurrent systemic corticosteroids Radiotherapy: - No prior radiotherapy for renal cell cancer Surgery: - See Disease Characteristics Other: - At least 4 weeks since other prior investigational drugs - No prior embolization of the renal artery - No prior or concurrent immunosuppressive medications - No other concurrent investigational drugs - No other concurrent anti-tumor therapy
Total Enrollment:
Location and Contact Information:
Antigenics, Incorporated *Recruiting*
Lexington, Massachusetts, 02421
United States
Recruiting Medical Office 866-805-8994
Additional Information:
Study ID Numbers: CDR0000068687; NDDO-ND030012,UCHC-IRB-00299,ANTIGENICS-C-100-12
Study Start Date:
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00017420
Other Stage 3 Renal Cell Cancer Studies:
1. Chemotherapy in Treating Patients With Advanced Kidney Cancer
2. Erlotinib in Treating Patients With Locally Advanced or Metastatic Papillary Renal Cell Cancer
3. UCN-01 in Treating Patients With Advanced or Metastatic Kidney Cancer
4. Erlotinib in Treating Patients With Advanced Kidney Cancer
5. Interleukin-2 and Bryostatin 1 in Treating Patients With Advanced Kidney Cancer
Related Studies:
Other stage 3 renal cell cancer Clinical Trials
Other Massachusetts Clinical Trials
Other Lexington Clinical Trials
Vaccine Therapy Following Surgery in Treating Patients With Locally Advanced Kidney Cancer
|
|
|
|
|
|
|
|
