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Sponsored by: |
Vion Pharmaceuticals |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00049699 |
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.
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 VNP40101M, a Novel Alkylating Agent, Administered Weekly for Patients With Advanced or Metastatic Cancer |
Study Start Date: | October 2002 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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, Connecticut | |
Veterans Affairs Medical Center - West Haven | |
West Haven, Connecticut, United States, 06516 | |
Yale Comprehensive Cancer Center | |
New Haven, Connecticut, United States, 06520-8028 | |
United States, Ohio | |
Ireland Cancer Center | |
Cleveland, Ohio, United States, 44106-5065 |
Study Chair: | Mario Sznol, MD | Vion Pharmaceuticals |
Study ID Numbers: | CDR0000258355, VION-CLI-028, YALE-HIC-16775 |
Study First Received: | November 12, 2002 |
Last Updated: | December 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00049699 |
Health Authority: | United States: Federal Government |
anaplastic large cell lymphoma angioimmunoblastic T-cell lymphoma intraocular lymphoma primary central nervous system lymphoma recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult Burkitt lymphoma recurrent adult Hodgkin lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent adult T-cell leukemia/lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma |
recurrent grade 3 follicular lymphoma recurrent mantle cell lymphoma recurrent mycosis fungoides/Sezary syndrome small intestine lymphoma stage IV adult diffuse large cell lymphoma stage IV adult diffuse mixed cell lymphoma stage IV adult diffuse small cleaved cell lymphoma stage IV adult Burkitt lymphoma stage IV adult Hodgkin lymphoma stage IV adult immunoblastic large cell lymphoma stage IV adult lymphoblastic lymphoma stage IV adult T-cell leukemia/lymphoma stage IV cutaneous T-cell non-Hodgkin lymphoma stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma |
Sezary syndrome Lymphoma, Mantle-Cell Hodgkin lymphoma, adult Lymphoma, small cleaved-cell, diffuse Ileal Diseases Lymphoma, large-cell, immunoblastic Central nervous system lymphoma, primary Duodenal Neoplasms Mycoses Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Large-Cell, Anaplastic Neoplasm Metastasis Hodgkin Disease Chronic lymphocytic leukemia Lymphoma, Large B-Cell, Diffuse |
Immunoproliferative Disorders Digestive System Neoplasms Leukemia, B-cell, chronic B-cell lymphomas Leukemia, T-Cell Gastrointestinal Neoplasms Anaplastic large cell lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell, Cutaneous Hodgkin's disease Gastrointestinal Diseases Cutaneous T-cell lymphoma Lymphoma, Follicular Lymphoma, B-Cell, Marginal Zone Sezary Syndrome |
Neoplastic Processes Neoplasms Neoplasms by Site Pathologic Processes |
Neoplasms by Histologic Type Immune System Diseases Jejunal Diseases |