Protocol Number: 02-C-0083

Title:

A Multidose Phase I Study of Oral CC5013, a Thalidomide Derivative, in Patients with Refractory Metastatic Cancer

Number:

02-C-0083

Summary:

This study will determine the highest safe dose of the experimental drug CC-5013 that can be given to patients with cancer. CC-5013 is structurally similar to thalidomide, which has shown some anti-tumor activity in humans. Like thalidomide, CC-5013 blocks blood vessel growth in tumors, but it may not have some of the side effects associated with thalidomide.

Patients 18 years of age and older with solid tumors or lymphoma for which standard treatments are not available or are no longer effective may be eligible for this study. Candidates are screened with a medical history and physical examination, chest x-ray, electrocardiogram, blood and urine tests, and imaging studies (e.g., CT, MRI, ultrasound or PET scan) to determine the extent of disease.

Participants take CC-5013 every morning. After the first day's dose, a special blood test is done to determine how much drug enters the blood. For this test, the patient may be hospitalized overnight to collect 12 blood samples within two-and-a-half days.

In addition to CC-5013 treatment, patients are followed in the clinic every 2 weeks for 1 month and then once a month for an examination and blood work. They have imaging studies every 2 months to determine the response to treatment. These studies include standard x-rays and possibly CT, MRI, ultrasound, or bone scans, depending on which is better to look at the tumor. A biopsy (removal of a small piece of tumor tissue) may be required for examination of the tissue under the microscope.

Treatment may continue for more than 6 months in patients who benefit from the therapy and do not have unacceptable side effects.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Completed Study; data analyses ongoing

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Currently Not Provided

Keyword(s):

Angiogenesis

Phase I

Pharmacokinetic

Cancer

New Drug

Recruitment Keyword(s):

Cancer

Tumor

Metastatic Cancer

Lymphoma

Condition(s):

Neoplasm

Investigational Drug(s):

CC5013

Investigational Device(s):

None

Interventions:

Drug: CC5013

Supporting Site:

National Cancer Institute

Contact(s):

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):

Stevens RJ, Andujar C, Edwards CJ, Ames PR, Barwick AR, Khamashta MA, Hughes GR. Thalidomide in the treatment of the cutaneous manifestations of lupus erythematosus: experience in sixteen consecutive patients. Br J Rheumatol. 1997 Mar;36(3):353-9.

Sampaio EP, Kaplan G, Miranda A, Nery JA, Miguel CP, Viana SM, Sarno EN. The influence of thalidomide on the clinical and immunologic manifestation of erythema nodosum leprosum. J Infect Dis. 1993 Aug;168(2):408-14.

Vogelsang GB, Farmer ER, Hess AD, Altamonte V, Beschorner WE, Jabs DA, Corio RL, Levin LS, Colvin OM, Wingard JR, et al. Thalidomide for the treatment of chronic graft-versus-host disease. N Engl J Med. 1992 Apr 16;326(16):1055-8.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department Clinical Research Informatics, CC.

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