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Sponsored by: |
Vion Pharmaceuticals |
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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: laromustine |
Phase I |
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 |
Study Chair: | Mario Sznol, MD | Vion Pharmaceuticals |
Study ID Numbers: | CDR0000068919, VION-CLI-011, NCI-V01-1669 |
Study First Received: | October 11, 2001 |
Last Updated: | December 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00025129 History of Changes |
Health Authority: | United States: Federal Government |
stage IV adult Hodgkin lymphoma recurrent adult Hodgkin lymphoma stage IV cutaneous T-cell non-Hodgkin lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma small intestine lymphoma unspecified adult solid tumor, protocol specific stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma stage IV grade 3 follicular lymphoma stage IV adult diffuse small cleaved cell lymphoma stage IV adult diffuse mixed cell lymphoma stage IV adult diffuse large cell lymphoma stage IV adult immunoblastic large cell lymphoma stage IV adult lymphoblastic lymphoma stage IV adult Burkitt lymphoma |
recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse large cell lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent adult Burkitt lymphoma stage IV adult T-cell leukemia/lymphoma recurrent adult T-cell leukemia/lymphoma primary central nervous system lymphoma intraocular lymphoma stage IV mantle cell lymphoma recurrent mantle cell lymphoma |
Lymphoma, Mantle-Cell Mantle Cell Lymphoma Ileal Diseases Follicular Lymphoma Duodenal Neoplasms Mycoses Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Large-Cell, Anaplastic Neoplasm Metastasis Hodgkin Disease Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Digestive System Neoplasms B-cell Lymphomas Leukemia, T-Cell |
Gastrointestinal Neoplasms Lymphoma, Non-Hodgkin Lymphoma, T-Cell, Cutaneous Gastrointestinal Diseases Lymphoma, Follicular Central Nervous System Lymphoma, Primary Lymphoma, B-Cell, Marginal Zone Sezary Syndrome Mycosis Fungoides Lymphoblastic Lymphoma Lymphoma, Large-cell, Immunoblastic Lymphoma, B-Cell Lymphoma, Small Cleaved-cell, Diffuse Leukemia Ileal Neoplasms |
Jejunal Neoplasms Neoplasms by Histologic Type Immunoproliferative Disorders Digestive System Neoplasms Immune System Diseases Gastrointestinal Diseases Intestinal Diseases Ileal Diseases Intestinal Neoplasms Duodenal Neoplasms |
Lymphatic Diseases Neoplasms Digestive System Diseases Neoplasms by Site Ileal Neoplasms Jejunal Diseases Gastrointestinal Neoplasms Lymphoproliferative Disorders Lymphoma Duodenal Diseases |