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VNP40101M in Treating Patients With Advanced Solid Tumors or Lymphomas Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about VNP40101M in Treating Patients With Advanced Solid Tumors or Lymphomas conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. VNP40101M in Treating Patients With Advanced Solid Tumors or Lymphomas Clinical research trials and VNP40101M in Treating Patients With Advanced Solid Tumors or Lymphomas health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like VNP40101M in Treating Patients With Advanced Solid Tumors or Lymphomas. VNP40101M in Treating Patients With Advanced Solid Tumors or Lymphomas Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a VNP40101M in Treating Patients With Advanced Solid Tumors or Lymphomas clinical trial. Subjects frequently get the best healthcare possible for their VNP40101M in Treating Patients With Advanced Solid Tumors or Lymphomas condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "V" Clinical Trials Conditions > VNP40101M in Treating Patients With Advanced Solid Tumors or Lymphomas  VNP40101M in Treating Patients With Advanced Solid Tumors or Lymphomas
VNP40101M in Treating Patients With Advanced Solid Tumors or Lymphomas
For Condition: adult solid tumor,Leukemia,Lymphoma,small intestine cancer
Status: Completed
Sponsor(s): Vion Pharmaceuticals ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of VNP40101M in treating patients who have advanced solid tumors or lymphomas.
Details: OBJECTIVES: - Determine the maximum tolerated dose of VNP40101M in patients with advanced solid tumors or lymphomas. - Determine the toxic effects of this drug in these patients. - Determine the pharmacokinetics of this drug in these patients. - Determine the anti-tumor effects of this drug in these patients. OUTLINE: This is a dose-escalation study. Patients receive VNP40101M IV over 15 minutes on day 1. Treatment repeats every 4 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 1-6 patients receive escalating doses of VNP40101M until the maximum tolerated dose (MTD) is determined. The MTD is defined as the highest dose at which no more than 1 of 6 patients experiences dose-limiting toxicity. PROJECTED ACCRUAL: Approximately 20-30 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 advanced and/or metastatic solid tumor or lymphoma for which no curative or standard effective therapy exists - Measurable or evaluable metastatic disease - No other hematologic malignancy - No large pleural, pericardial, or peritoneal effusions - No requirement for immediate palliative treatment, including surgery - No symptomatic brain metastases or metastases with substantial edema - Asymptomatic brain metastases or primary CNS disease allowed if neurologic deficits are stable PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-1 Life expectancy: - At least 3 months Hematopoietic: - Granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hematocrit at least 30% (transfusion allowed) - No active uncontrolled bleeding Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - ALT and AST no greater than 1.5 times ULN (3 times ULN if liver metastases present) - Alkaline phosphatase no greater than 1.5 times ULN (3 times ULN if liver or bone metastases present) - PT and aPTT no greater than 1.5 times ULN - Albumin at least 2.5 g/dL Renal: - Creatinine no greater than 2.0 mg/dL Cardiovascular: - Ejection fraction at least 45% - No active heart disease - No myocardial infarction within the past 3 months - No symptomatic coronary artery disease - No arrhythmias requiring medication - No uncontrolled congestive heart failure Pulmonary: - DLCO and FEV_1 at least 60% of predicted - No dyspnea with minimal to moderate exertion Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 3 months after study participation - HIV negative - No active infection - Persistent stable chronic toxic effects from prior therapy allowed if no greater than grade 1 - No bleeding diathesis (e.g., active peptic ulcer disease) PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 3 weeks since prior biologic agents and recovered - At least 6 months since prior high-dose chemotherapy regimen with stem cell support Chemotherapy: - See Biologic therapy - At least 3 weeks since prior cytotoxic agents (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy: - At least 2 weeks since prior hormonal therapy and recovered Radiotherapy: - At least 3 weeks since prior radiotherapy and recovered Surgery: - See Disease Characteristics - At least 2 weeks since prior surgery and recovered Other: - No other concurrent standard therapy for cancer - No other concurrent investigational agents - No concurrent disulfiram (Antabuse)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MarioSznol, Study Chair, Vion Pharmaceuticals
Veterans Affairs Medical Center - West Haven
West Haven, Connecticut, 06516
United States
Yale Comprehensive Cancer Center
New Haven, Connecticut, 06520-8028
United States
Arizona Clinical Research Center
Tucson, Arizona, 85712
United States
Additional Information:
Study ID Numbers: CDR0000068919; NCI-V01-1669,VION-CLI-011
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00025129
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4. UCN-01 and Fludarabine to Treat Lymphoma and Leukemia
5. High-Dose Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
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VNP40101M in Treating Patients With Advanced Solid Tumors or Lymphomas
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