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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00352040 |
RATIONALE: Drugs used in chemotherapy, such as CDDO, 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 CDDO 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: CDDO Other: laboratory biomarker analysis Other: pharmacological study |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | CDDO Phase I Study in Patients With Solid Tumors and Lymphomas |
Estimated Enrollment: | 40 |
Study Start Date: | May 2006 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study.
Patients receive CDDO IV continuously on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 1-6 patients receive escalating doses of CDDO until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 1 of 6 patients experience dose-limiting toxicity. At least 10 patients are treated at the MTD.
Patients undergo blood collection periodically and possible tumor biopsies for pharmacokinetic and biomarker correlative studies.
PROJECTED ACCRUAL: A total of 40 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 meeting all of the following criteria:
No known brain metastases
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | |
Bethesda, Maryland, United States, 20892-1182 |
Investigator: | Janelle Bingham, RN | NCI - Medical Oncology Branch |
Principal Investigator: | Shivaani Kummar, MD | NCI - Medical Oncology Branch |
Study ID Numbers: | CDR0000483142, NCI-06-C-0151, NCI-P6704, NCI-7396 |
Study First Received: | July 13, 2006 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00352040 History of Changes |
Health Authority: | United States: Food and Drug Administration |
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 nodal marginal zone B-cell lymphoma recurrent adult grade III lymphomatoid granulomatosis recurrent mycosis fungoides/Sezary syndrome stage III mycosis fungoides/Sezary syndrome stage IV mycosis fungoides/Sezary syndrome Waldenstrom macroglobulinemia 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 |
Lymphoma, Mantle-Cell Mantle Cell Lymphoma Ileal Diseases Follicular Lymphoma Duodenal Neoplasms Mycoses 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 Sezary Syndrome Mycosis Fungoides Lymphoblastic Lymphoma Lymphoma, Large-cell, Immunoblastic Lymphoma, B-Cell Lymphoma, Small Cleaved-cell, Diffuse Leukemia Ileal Neoplasms Cutaneous T-cell Lymphoma |
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 |