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Sponsored by: |
Vion Pharmaceuticals |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00025129 |
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.
Condition | Intervention | Phase |
Lymphoma Small Intestine Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Drug: VNP40101M |
Phase I |
MedlinePlus related topics: | Cancer Intestinal Cancer Lymphoma |
ChemIDplus related topics: | Cloretazine |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Trial of VNP4010M, A Novel Alkylating Agent for Patients With Advanced or Metastatic Cancer |
Study Start Date: | March 2001 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
No symptomatic brain metastases or metastases with substantial edema
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Arizona | |||||
Arizona Clinical Research Center | |||||
Tucson, Arizona, United States, 85712 | |||||
United States, Connecticut | |||||
Veterans Affairs Medical Center - West Haven | |||||
West Haven, Connecticut, United States, 06516 | |||||
Yale Comprehensive Cancer Center | |||||
New Haven, Connecticut, United States, 06520-8028 |
Vion Pharmaceuticals |
Study Chair: | Mario Sznol, MD | Vion Pharmaceuticals |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000068919, VION-CLI-011, NCI-V01-1669 |
First Received: | October 11, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00025129 |
Health Authority: | United States: Federal Government |
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