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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00031941 |
Purpose
RATIONALE: CC-5013 may stop the growth of cancer by stopping blood flow to the tumor.
PURPOSE: Phase I trial to study the effectiveness of CC-5013 in treating patients who have solid tumors and/or lymphoma that did not respond to previous therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma Small Intestine Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Drug: lenalidomide |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Multidose Phase I Study of Oral CC5013, a Thalidomide Derivative, in Patients With Refractory Metastatic Cancer |
| Study Start Date: | April 2002 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a dose-escalation study.
Patients receive oral CC-5013 on day 1. Within 4-10 days, patients begin second course and receive oral CC-5013 once daily on days 1-21. Subsequent courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of CC-5013 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed at 2 weeks.
PROJECTED ACCRUAL: A total of 3-51 patients will be accrued for this study.
Eligibility| 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:
Contacts and Locations| United States, Maryland | |
| NCI - Center for Cancer Research | |
| Bethesda, Maryland, United States, 20892 | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
| Bethesda, Maryland, United States, 20892-1182 | |
| Study Chair: | William Dahut, MD | National Cancer Institute (NCI) |
More Information
| Study ID Numbers: | CDR0000069241, NCI-02-C-0083 |
| Study First Received: | March 8, 2002 |
| Last Updated: | November 5, 2009 |
| ClinicalTrials.gov Identifier: | NCT00031941 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 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 stage IV mantle cell lymphoma recurrent mantle cell lymphoma angioimmunoblastic T-cell lymphoma anaplastic large cell lymphoma recurrent mycosis fungoides/Sezary syndrome |
|
Jejunal Neoplasms Neoplasms by Histologic Type Immunoproliferative Disorders Digestive System Neoplasms Immune System Diseases Antineoplastic Agents Gastrointestinal Diseases Lenalidomide Intestinal Diseases Ileal Diseases Pharmacologic Actions Intestinal Neoplasms |
Duodenal Neoplasms Lymphatic Diseases Neoplasms Digestive System Diseases Neoplasms by Site Ileal Neoplasms Jejunal Diseases Therapeutic Uses Gastrointestinal Neoplasms Lymphoproliferative Disorders Lymphoma Duodenal Diseases |