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Intravenous Interleukin-4 PE38KDEL Cytotoxin in Treating Patients With Recurrent or Metastatic Kidney Cancer, Non-Small Cell Lung Cancer, or Breast Cancer Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Intravenous Interleukin-4 PE38KDEL Cytotoxin in Treating Patients With Recurrent or Metastatic Kidney Cancer, Non-Small Cell Lung Cancer, or Breast Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Intravenous Interleukin-4 PE38KDEL Cytotoxin in Treating Patients With Recurrent or Metastatic Kidney Cancer, Non-Small Cell Lung Cancer, or Breast Cancer Clinical research trials and Intravenous Interleukin-4 PE38KDEL Cytotoxin in Treating Patients With Recurrent or Metastatic Kidney Cancer, Non-Small Cell Lung Cancer, or Breast Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Intravenous Interleukin-4 PE38KDEL Cytotoxin in Treating Patients With Recurrent or Metastatic Kidney Cancer, Non-Small Cell Lung Cancer, or Breast Cancer. Intravenous Interleukin-4 PE38KDEL Cytotoxin in Treating Patients With Recurrent or Metastatic Kidney Cancer, Non-Small Cell Lung Cancer, or Breast Cancer Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Intravenous Interleukin-4 PE38KDEL Cytotoxin in Treating Patients With Recurrent or Metastatic Kidney Cancer, Non-Small Cell Lung Cancer, or Breast Cancer clinical trial. Subjects often receive the most expert healthcare possible for their Intravenous Interleukin-4 PE38KDEL Cytotoxin in Treating Patients With Recurrent or Metastatic Kidney Cancer, Non-Small Cell Lung Cancer, or Breast Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Intravenous Interleukin-4 PE38KDEL Cytotoxin in Treating Patients With Recurrent or Metastatic Kidney Cancer, Non-Small Cell Lung Cancer, or Breast Cancer  Intravenous Interleukin-4 PE38KDEL Cytotoxin in Treating Patients With Recurrent or Metastatic Kidney Cancer, Non-Small Cell Lung Cancer, or Breast Cancer
Intravenous Interleukin-4 PE38KDEL Cytotoxin in Treating Patients With Recurrent or Metastatic Kidney Cancer, Non-Small Cell Lung Cancer, or Breast Cancer
For Condition: recurrent renal cell cancer,Male Breast Cancer,recurrent non-small cell lung cancer,stage 4 breast cancer,stage 4 non-small cell lung cancer,stage 4 renal cell cancer,recurrent breast cancer
Status: No longer recruiting
Sponsor(s): Neurocrine Biosciences ,
Synopsis: RATIONALE: Interleukin-4 PE38KDEL cytotoxin may be able to deliver cancer-killing substances directly to solid tumor cells. PURPOSE: Phase I trial to study the effectiveness of intravenous interleukin-4 PE38KDEL cytotoxin in treating patients who have recurrent or metastatic kidney cancer, non-small cell lung cancer, or breast cancer that has not responded to previous treatment.
Details: OBJECTIVES: - Determine the maximum tolerated dose of interleukin-4 PE38KDEL cytotoxin in patients with recurrent or unresponsive, metastatic renal cell, non-small cell lung, or breast cancer that overexpresses interleukin-4 receptors. - Determine the qualitative and quantitative toxic effects of this drug, including the duration and intensity of these toxic effects, in these patients. - Determine the pharmacokinetic behavior of this drug in these patients. - Determine the antibody response (if any) in patients treated with this drug. - Determine, in a preliminary manner, the antitumor activity of this drug in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients receive interleukin-4 PE38KDEL cytotoxin (NBI-3001) IV over 10 minutes once daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression, unacceptable toxicity, or detection of neutralizing antibodies. Cohorts of 3-6 patients receive escalating doses of NBI-3001 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: A maximum of 36 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 recurrent or unresponsive, metastatic renal cell, non-small cell lung, or breast cancer that has been treated previously with standard surgery, radiotherapy, chemotherapy, or immunotherapy or for which no available treatment options currently exist - Confirmed overexpression of interleukin-4 receptors - Measurable disease (lesions greater than 10 mm by CT scan) OR - Evaluable disease - No prior or concurrent clinically significant brain metastases - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - 18 and over Sex: - Male or female Menopausal status: - Not specified Performance status: - Karnofsky 70-100% Life expectancy: - More than 12 weeks 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 times upper limit of normal (ULN) - Transaminases no greater than 1.5 times ULN - Albumin at least 2.5 g/dL - Hepatitis B surface antigen negative - Hepatitis C antibody negative - No prior or concurrent hepatic disease (e.g., hepatitis or alcoholic liver disease) Renal: - Creatinine no greater than 2.0 mg/dL Cardiovascular: - See Surgery - Electrocardiogram normal - MUGA scan normal - No congestive heart failure - No cardiac arrhythmia requiring treatment - No myocardial infarction - No clinical evidence of coronary artery disease (unless there is a cardiac evaluation and evidence of adequate coronary function by a stress test or angiography) Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception for 4 weeks before, during, and for at least 3 months after study - No concurrent underlying medical condition that would preclude study or cannot be controlled - No active infection PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics Chemotherapy: - See Disease Characteristics - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - At least 4 weeks since prior radiotherapy Surgery: - See Disease Characteristics - At least 1 year since prior surgery or angioplasty for coronary artery disease Other: - At least 28 days since prior experimental drugs and recovered
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HenryPan, Study Chair, Neurocrine Biosciences
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-5907
United States
Arizona Cancer Center
Tucson, Arizona, 85724
United States
Additional Information:
Study ID Numbers: CDR0000069228; NCI-V02-1692,NBI-3001-ST-0101,UCLA-0108085,UARIZ-HSC-01196
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00039052
Other Recurrent Breast Cancer Studies:
1. Gemcitabine, Carboplatin, and Bortezomib in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
2. 10-Propargyl-10-Deazaaminopterin in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
3. Monoclonal Antibody Plus Carboplatin and Paclitaxel in Treating Patients With Advanced Non-Small Cell Lung Cancer
4. Gemcitabine Plus Docetaxel or Irinotecan in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
5. Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer That Overexpresses HER2
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Intravenous Interleukin-4 PE38KDEL Cytotoxin in Treating Patients With Recurrent or Metastatic Kidney Cancer, Non-Small Cell Lung Cancer, or Breast Cancer
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