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VNP40101M in Treating Patients With Advanced or Metastatic Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on VNP40101M in Treating Patients With Advanced or Metastatic Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. VNP40101M in Treating Patients With Advanced or Metastatic Cancer Clinical research trials and VNP40101M in Treating Patients With Advanced or Metastatic Cancer healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as VNP40101M in Treating Patients With Advanced or Metastatic Cancer. VNP40101M in Treating Patients With Advanced or Metastatic Cancer Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a VNP40101M in Treating Patients With Advanced or Metastatic Cancer clinical trial. Human subjects often receive the most effective healthcare possible for their VNP40101M in Treating Patients With Advanced or Metastatic Cancer condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "V" Clinical Trials Conditions > VNP40101M in Treating Patients With Advanced or Metastatic Cancer  VNP40101M in Treating Patients With Advanced or Metastatic Cancer
VNP40101M in Treating Patients With Advanced or Metastatic Cancer
For Condition: small intestine cancer,Leukemia,adult solid tumor,Lymphoma
Status: No longer recruiting
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 or metastatic cancer.
Details: OBJECTIVES: - Determine the toxic effects of VNP40101M in patients with advanced or metastatic solid tumor or lymphoma. - Determine the maximum tolerated dose of this drug in these patients. - Determine the pharmacokinetics of this drug in these patients. - Determine the antitumor effects of this drug in these patients. OUTLINE: This is a dose-escalation study. Patients receive VNP40101M IV over 15 minutes on days 1, 8, and 15. Treatment repeats every 28 days. Cohorts of 3-6 patients receive escalating doses of VNP40101M until the maximum tolerated dose is determined. PROJECTED ACCRUAL: Approximately 20 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 or metastatic solid tumor or lymphoma for which no curative or standard effective therapy exists - Measurable or evaluable disease - Primary brain tumors or brain metastases allowed provided neurologic deficits are stable and do not preclude study compliance 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 bleeding diathesis Hepatic - PT and PTT no greater than 1.5 times the upper limit of normal (ULN) - Bilirubin no greater than 1.5 times ULN - ALT and AST no greater than 1.5 times ULN (3 times ULN if liver metastases present) - Albumin at least 2.5 gm/dL Renal - Creatinine no greater than 2.0 mg/dL Cardiovascular - At least 3 months since prior myocardial infarction - No symptomatic coronary artery disease - No arrhythmias requiring medication - No uncontrolled congestive heart failure Pulmonary - No dyspnea on minimal or moderate exertion - DLCO and FEV1 at least 60% predicted Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No uncontrolled active bleeding (e.g., active peptic ulcer disease) - No active infection - HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy - Recovered from acute toxicities of prior biologic therapy (persisting, chronic toxicity allowed if stable and no greater than grade 1) Chemotherapy - More than 6 months since prior high-dose chemotherapy with stem cell support - More than 3 weeks since prior cytotoxic chemotherapy (6 weeks for mitomycin or nitrosoureas) - Recovered from acute toxicities of prior chemotherapy (persisting, chronic toxicity allowed if stable and no greater than grade 1) Endocrine therapy - At least 2 weeks since prior hormonal therapy Radiotherapy - Recovered from acute toxicities of prior radiotherapy (persisting, chronic toxicity allowed if stable and no greater than grade 1) Surgery - At least 2 weeks since prior surgery Other - No other concurrent standard or investigational treatment for cancer - No concurrent disulfiram
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
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
Yale Comprehensive Cancer Center
New Haven, Connecticut, 06520-8028
United States
Additional Information:
Study ID Numbers: CDR0000258355; VION-CLI-028,YALE-HIC-16775
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00049699
Other Lymphoma Studies:
1. Bone Marrow Transplantation With Specially Treated Bone Marrow in Treating Patients With Hematologic Cancer That Has Not Responded to Previous Therapy
2. In Vitro Studies of Immunological and Stem Cell Function in Peripheral Blood Mononuclear Cells in Patients
3. PS-341 in Treating Patients With Advanced Solid Tumors or Lymphoma
4. Combination Chemotherapy in Treating Patients With Advanced Cancer
5. Biological Therapy Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Cancer
Related Studies:
Other Lymphoma Clinical Trials
Other Connecticut Clinical Trials
Other New Haven Clinical Trials
VNP40101M in Treating Patients With Advanced or Metastatic Cancer
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