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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00450502 |
RATIONALE: Drugs used in chemotherapy, such as batracylin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I trial is studying the side effects and best dose of batracylin in treating patients with metastatic or unresectable solid tumors or lymphoma.
Condition | Intervention | Phase |
---|---|---|
Lymphoma Small Intestine Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Drug: daniquidone Other: pharmacological study |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study of Batracylin (NSC 320846) in Subjects With Solid Tumors and Lymphomas |
Estimated Enrollment: | 36 |
Study Start Date: | March 2007 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study.
Patients receive oral batracylin on days 1-7. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 1-6 patients receive escalating doses of batracylin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Peripheral blood samples are collected on days 1, 3, and 7 of the first course and on day 1 of subsequent courses for pharmacokinetic and other research studies.
After completion of study treatment, patients are followed for 4 weeks.
PROJECTED ACCRUAL: A total of 36 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:
Histologically confirmed solid tumors or lymphoma
PATIENT CHARACTERISTICS:
No clinically significant illnesses including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
Bethesda, Maryland, United States, 20892-1182 | |
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 |
Principal Investigator: | Shivaani Kummar, MD | NCI - Medical Oncology Branch |
Study ID Numbers: | CDR0000536009, NCI-07-C-0097 |
Study First Received: | March 20, 2007 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00450502 History of Changes |
Health Authority: | Unspecified |
unspecified adult solid tumor, protocol specific anaplastic large cell lymphoma angioimmunoblastic T-cell lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue intraocular lymphoma nodal marginal zone B-cell lymphoma recurrent adult Burkitt lymphoma recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell 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 marginal zone lymphoma recurrent small lymphocytic lymphoma small intestine lymphoma splenic marginal zone lymphoma stage III adult Burkitt lymphoma stage III adult diffuse large cell lymphoma stage III adult diffuse mixed cell lymphoma stage III adult diffuse small cleaved cell lymphoma stage III adult Hodgkin lymphoma stage III adult immunoblastic large cell lymphoma stage III adult lymphoblastic lymphoma |
Lymphoma, Mantle-Cell Mantle Cell Lymphoma Ileal Diseases Follicular Lymphoma Duodenal Neoplasms Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Large-Cell, Anaplastic Hodgkin Disease Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Digestive System Neoplasms Waldenstrom Macroglobulinemia B-cell Lymphomas Leukemia, T-Cell Gastrointestinal Neoplasms |
Lymphoma, Non-Hodgkin Lymphoma, T-Cell, Cutaneous Gastrointestinal Diseases Lymphoma, Follicular Lymphoma, B-Cell, Marginal Zone Lymphoblastic Lymphoma Lymphoma, Large-cell, Immunoblastic Lymphoma, B-Cell Lymphoma, Small Cleaved-cell, Diffuse Leukemia Ileal Neoplasms Cutaneous T-cell Lymphoma Lymphoma, T-Cell Lymphoma, Large-Cell, Immunoblastic Leukemia, B-cell, Chronic |
Jejunal Neoplasms Digestive System Neoplasms Neoplasms by Histologic Type Immunoproliferative Disorders 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 Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Duodenal Diseases |