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Chemotherapy and Biological Therapy in Treating Patients With Locally Advanced or Metastatic Kidney Cancer Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Chemotherapy and Biological Therapy in Treating Patients With Locally Advanced or Metastatic Kidney Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Chemotherapy and Biological Therapy in Treating Patients With Locally Advanced or Metastatic Kidney Cancer Clinical research trials and Chemotherapy and Biological Therapy in Treating Patients With Locally Advanced or Metastatic Kidney Cancer medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Chemotherapy and Biological Therapy in Treating Patients With Locally Advanced or Metastatic Kidney Cancer. Chemotherapy and Biological Therapy in Treating Patients With Locally Advanced or Metastatic Kidney Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Chemotherapy and Biological Therapy in Treating Patients With Locally Advanced or Metastatic Kidney Cancer clinical trial. Participants frequently get the best healthcare available for their Chemotherapy and Biological Therapy in Treating Patients With Locally Advanced or Metastatic Kidney Cancer condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Chemotherapy and Biological Therapy in Treating Patients With Locally Advanced or Metastatic Kidney Cancer  Chemotherapy and Biological Therapy in Treating Patients With Locally Advanced or Metastatic Kidney Cancer
Chemotherapy and Biological Therapy in Treating Patients With Locally Advanced or Metastatic Kidney Cancer
For Condition: recurrent renal cell cancer,stage 3 renal cell cancer,stage 4 renal cell cancer
Status: Completed
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies such as interferon alfa use different ways to stimulate the immune system and stop cancer cells from growing. Combining biological therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining chemotherapy with biological therapy in treating patients who have locally advanced or metastatic kidney cancer.
Details: OBJECTIVES: - Determine the maximum tolerated dose of CCI-779 in combination with interferon alfa in patients with locally advanced or metastatic renal cell cancer. - Determine the safety and tolerability of this regimen in these patients. - Determine, preliminarily, any antitumor activity of this regimen in these patients. - Determine the pharmacokinetics of this regimen in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients receive interferon alfa (IFN-A) subcutaneously 3 times a week. Beginning on week 2, patients also receive CCI-779 IV over 30 minutes once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of at least 6 patients receive escalating doses of CCI-779 and then IFN-A until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 20 additional patients are treated at that dose level. Patients are followed at 30 days. 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: - Histologically confirmed locally advanced or metastatic renal cell cancer - Progressive disease after treatment with 0-2 courses of immunotherapy, chemotherapy, or other systemic therapy for advanced disease - Measurable or evaluable disease - No concurrent CNS metastases - Prior CNS metastases allowed if no residual disease by MRI PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 Life expectancy - At least 3 months Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 9 g/dL Hepatic - Bilirubin no greater than 1.5 mg/dL - AST and ALT no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases present) Renal - Creatinine less than 2 mg/dL OR - Creatinine clearance at least 60 mL/min Cardiovascular - No unstable angina - No myocardial infarction within the past 6 months Other - Cholesterol no greater than 350 mg/dL - Triglycerides no greater than 400 mg/dL - HIV negative - Not immunocompromised - No active autoimmune disorder - No active infection requiring antibiotic therapy - No other serious concurrent illness - No known hypersensitivity to components of CCI-779, interferon alfa, diphenhydramine hydrochloride, or both acetaminophen and nonsteroidal anti- inflammatory drugs - No other major illness that would preclude study participation - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 3 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - At least 3 weeks since prior immunotherapy - No prior interferon alfa - No other concurrent immunotherapy - No prophylactic growth factors - Concurrent epoetin alfa allowed Chemotherapy - See Disease Characteristics - At least 3 weeks since prior chemotherapy - No prior CCI-779 - No other concurrent chemotherapy Endocrine therapy - No concurrent hormonal therapy for malignancy (megestrol for appetite loss allowed) - Concurrent inhaled or replacement steroids allowed Radiotherapy - At least 3 weeks since prior radiotherapy - No concurrent radiotherapy Surgery - At least 3 weeks since prior surgery Other - See Disease Characteristics - At least 3 weeks since prior immunosuppressive agents - At least 4 weeks since prior investigational agents - No other concurrent investigational agents - No concurrent immunosuppressive therapy - No concurrent anticonvulsants known to be cytochrome P450 inducers, ketoconazole, diltiazem, rifampin, terfenadine, cisapride, astemizole, or pimozide - No concurrent maintenance therapy for life-threatening ventricular arrhythmia
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertMotzer, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000256468; W-AR-3066K1-124-US,NCI-G02-2104,MSKCC-02023,WYETH-C-C0125-32
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00045370
Other Recurrent Renal Cell Cancer Studies:
1. Chemotherapy in Treating Patients With Metastatic Kidney Cancer
2. Chemotherapy and Biological Therapy in Treating Patients With Locally Advanced or Metastatic Kidney Cancer
3. Erlotinib in Treating Patients With Locally Advanced or Metastatic Papillary Renal Cell Cancer
4. Pentostatin Followed by Peripheral Stem Cell Transplantation in Treating Patients With Advanced Kidney Cancer
5. Interleukin-2 and Bryostatin 1 in Treating Patients With Advanced Kidney Cancer
Related Studies:
Other recurrent renal cell cancer Clinical Trials
Other New York Clinical Trials
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Chemotherapy and Biological Therapy in Treating Patients With Locally Advanced or Metastatic Kidney Cancer
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