CC-5013 in Treating Patients With Cancer That Has Not Responded to Previous Therapy
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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 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: 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 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine the maximum tolerated dose of CC-5013 in patients with refractory solid tumors and/or lymphoma.
- Characterize the pharmacokinetic profile of this drug in these patients.
- Determine whether any correlations can be made between plasma concentrations of this drug and toxicity or clinical activity or biological activity in these patients.
- Characterize the side effect profile of this drug in these patients.
- Determine the dose-limiting toxicity of this drug in these patients.
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:
- Histologically confirmed refractory solid tumor and/or lymphoma
- No brain metastases or primary CNS malignancies
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- More than 3 months
Hematopoietic:
- Granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin normal
- ALT and AST less than 2.5 times normal
Renal:
- Creatinine no greater than 1.5 mg/dL OR
- Creatinine clearance greater than 60 mL/min
Cardiovascular:
- No unstable or newly diagnosed angina pectoris
- No myocardial infarction within the past 6 months
- No New York Heart Association class II, III, or IV congestive heart failure
Pulmonary:
- No chronic obstructive lung disease requiring oxygen therapy
Other:
- No uncontrolled seizures
- No concurrent acute critical illness
- No serious untreated infection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 2 months after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since prior biologic therapy
Chemotherapy:
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or carboplatin)
- No concurrent cytotoxic chemotherapy
Endocrine therapy:
- At least 4 weeks since prior hormonal therapy
- Concurrent luteinizing hormone-releasing hormone agonist required in patients with prostate cancer unless prior orchiectomy has been performed
Radiotherapy:
- At least 4 weeks since prior radiotherapy
Surgery:
- See Endocrine therapy
- Prior surgery allowed
Other:
- Recovered from prior therapy
- No concurrent anticonvulsants (e.g., phenobarbital, phenytoin, or carbamazepine)
- No concurrent rifampin
- No concurrent grapefruit juice
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 | NCI - Medical Oncology Branch |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00031941 History of Changes |
| Obsolete Identifiers: | NCT00029081 |
| Other Study ID Numbers: | 020083, 02-C-0083, CDR0000069241 |
| Study First Received: | March 8, 2002 |
| Last Updated: | March 14, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
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 |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Lymphoma, Large-Cell, Immunoblastic Duodenal Neoplasms Ileal Neoplasms Jejunal Neoplasms Intestinal Neoplasms Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Duodenal Diseases Intestinal Diseases Ileal Diseases Jejunal Diseases Lenalidomide Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013