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Protocol Details

A Phase I/II Study of the Safety, Pharmacokinetics and Efficacy of Pomalidomide (CC-4047) in the Treatment of Kaposi Sarcoma in Individuals With or Without HIV

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

12-C-0047

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: No longer recruiting/follow-up only
Gender: Male & Female
Min Age: 18
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Children;
Pregnant Women and Fetuses

Special Instructions

Currently Not Provided

Keywords

Human Herpesvirus-8/HHV8;
Immune Modulation;
CC-4047;
IMiD

Recruitment Keyword(s)

Kaposi Sarcoma

Condition(s)

Kaposi Sarcoma;
Sarcoma, Kaposi

Investigational Drug(s)

Pomalidomide

Investigational Device(s)

None

Intervention(s)

Drug: Pomalidomide

Supporting Site

National Cancer Institute

Background:

- Pomalidomide is a drug that can treat cancer through several mechanisms. It is taken by mouth (orally). Pomalidomide can help treat cancer by blocking certain factors that promote tumor growth or by stimulating the immune system to attack tumor cells. It also prevents the growth of new blood vessels that help cancer grow. Researchers want to see if pomalidomide can treat Kaposi sarcoma, a rare and potentially fatal skin cancer. Because Kaposi sarcoma may be associated with human immunodeficiency virus (HIV) infection, researchers want to test the drug in people with and without HIV infection.

Objectives:

- To see if pomalidomide is a safe and effective treatment for Kaposi sarcoma in people with or without HIV.

Eligibility:

- Individuals at least 18 years of age who have Kaposi sarcoma.

- Participants may or may not have HIV infection.

Design:

- Potential participants will be screened with a medical history and physical exam. Blood and saliva samples will be taken and a chest X-ray will be performed. A skin biopsy of a Kaposi sarcoma lesion may be performed if one has not already been done. Other imaging studies may be performed if needed.

- Participants will take pomalidomide capsules every day for 3 weeks, followed by a 1-week break. These 28 days are one cycle of treatment.

- Participants will have up six cycles of treatment, unless the lesions completely resolve sooner. If there are signs of improvement after six cycles but the lesions are not completely gone, up to another six cycles of treatment may be given.

- Treatment will be monitored with frequent blood tests and other studies including photograph and other imaging of skin lesions.

- Participants will have regular follow-up visits for 5 years after stopping treatment.

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Eligibility

INCLUSION CRITERIA:

- Age greater than or equal to 18 Years.

- Any HIV status.

- Kaposi sarcoma pathologically confirmed by Department of Pathology, Clinical Center, National Institutes of Health.

- At least five measurable KS lesions with no previous local radiation, surgical or intralesional cytotoxic therapy that would prevent response assessment for that lesion.

- ECOG Performance Status less than or equal to 2

- Life expectancy greater than or equal to 6 months

- For patients with HIV-associated KS:

-- Must be receiving, and adherent to, a HAART regimen consistent with current clinical guidelines.

-- Must have been receiving HAART for at least one month.

-- Must have achieved an HIV VL <10,000 copies/mL.

-The following hematological parameters:

--Hemoglobin greater than or equal to 10 g/dL

--Platelets greater than or equal to 75,000 cells/mm(3)

--Absolute neutrophil count (ANC) greater than or equal to 1000 cells/mm3

- The following biochemical parameters:

-- Estimated or measured creatinine clearance greater than or equal to 45mL/minute

-- Serum alanine aminotransferase (ALT) less than or equal to 2.5 times upper limit of normal

--Serum aspartate aminotransferase (AST) less than or equal to 2.5 times upper limit of normal

-- Bilirubin less than or equal to 1.5 times upper limit of normal unless the patient is receiving protease inhibitor therapy (e.g. indinavir, ritonavir, nelfinavir, or atazanavir) known to be associated with increased bilirubin, in which case total bilirubin less than or equal to 7.5 mg/dL with direct fraction less than or equal to 0.7 mg/dL.

- Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 14 days prior to and again within 24 hours before starting pomalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking pomalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a vasectomy. All subjects must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods, and also

- All study participants must agree to be registered into the mandatory POMALYST REMS program, and be willing and able to comply with the requirements of the POMALYST REMS program.

-Females of reproductive potential must be willing to adhere to the scheduled pregnancy testing as required in the POMALYST REMS program.

- Able to take aspirin 81mg daily or if intolerant of aspirin, able to take a substitute thromboprophylaxis such as low molecular weight heparin at a thromboprophylactic dose (such as enoxaparin 0.5mg/kg once daily).

- Willing and able to give informed consent.

- For subjects with HIV-associated entered after a tolerable dose has been determined, KS lesions must be either:

-- Increasing despite HAART and HIV suppression below the limit of detection (48 copies/mL) in the two months prior to screening or

-- Stable despite HAART for at least three months. Stable disease must be symptomatic (examples of symptomatic disease include disease associated with pain, edema, psychological distress and/or social withdrawal). This is to gain preliminary information about pomalidomide activity without confounding due to HAART initiation.

EXCLUSION CRITERIA:

- Symptomatic pulmonary KS.

- Symptomatic visceral KS (except for non-ulcerating disease restricted to the oral cavity).

- Specific KS therapy, including cytotoxic chemotherapy but not including HAART, within the past 4 weeks (6 weeks if the therapy was bevacizumab).

- Use of other anticancer treatments or agents within the past 4 weeks (6 weeks if the therapy was a monoclonal antibody).

- History of malignant tumors other than KS, unless:

-- In complete remission for greater than or equal to 1 year from the time response was first documented or

-- Completely resected basal cell carcinoma or

-- In situ squamous cell carcinoma of the cervix or anus.

- History of infection meeting any of the following criteria:

-- Any infection that would be scored as grade 4 by CTCAE that occurred within six weeks of study screening.

-- Any infection that would be scored as grade 3 by CTCAE that occurred within two weeks of study screening.

-- History of fungal and mycobacterial infections, unless at least six weeks has passed since the completion of induction antimicrobial therapy. Patients may be receiving consolidation therapy for infections of these types.

- Any abnormality that would be scored as a greater than or equal to grade 3 toxicity by CTCAE, except:

--Obesity is not considered an abnormality for the purposes of eligibility assessment unless in the opinion of the Principal Investigator or Lead Associate Investigator its clinical consequences in a particular subject places the subject at unacceptable risk if they were to participate in the study or confounds the ability to interpret data from the study.

-- Lymphopenia

-- Asymptomatic hyperuricemia, hypophosphatemia, or creatine kinase (CK) Elevations

-- Direct manifestations of KS

-- Direct manifestations of HIV infection, except for neurologic or cardiac manifestations

-- Direct manifestations of HIV therapy, except for neurologic or cardiac manifestations.

- History of venous or arterial thromboembolism, unless:

-- Line-related thrombosis without embolus occurring greater than or equal to 1 year prior to screening.

Complications resulting from atherosclerotic coronary artery disease, peripheral vascular disease, or cerebrovascular disease (including infarction) are not considered exclusion criteria unless in the opinion of the Principal Investigator or Lead Associate Investigator their clinical consequences in a particular subject places the subject at unacceptable risk if they were to participate in the study orconfounds the ability to interpret data from the study

- Known drug-related, inherited, or acquired procoagulant disorder including prothrombin gene mutation 20210, antithrombin III deficiency, protein C deficiency, protein S deficiency and antiphospholipid syndrome but not including heterozygosity for the Factor V Leiden mutation or the presence of a lupus anticoagulant in the absence of other criteria for the antiphospholipid syndrome.

- Pregnancy.

- Breast feeding (if lactating, must agree not to breast feed while taking pomalidomide).

- Prior therapy with pomalidomide.

- Known hypersensitivity to thalidomide, lenalidomide or pomalidomide. including prior development of erythema nodosum if characterized by a desquamating rash while taking thalidomide, lenalidomide or pomalidomide.

- Any condition, including the presence of laboratory abnormalities, which in the opinion of the Principal Investigator or Lead Associate Investigator places the subject at unacceptable risk if they were to participate in the study or confounds the ability to interpret data from the study.


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Citations:

Krown SE. AIDS-associated Kaposi's sarcoma: pathogenesis, clinical course and treatment. AIDS. 1988 Apr;2(2):71-80.

Chang Y, Cesarman E, Pessin MS, Lee F, Culpepper J, Knowles DM, Moore PS. Identification of herpesvirus-like DNA sequences in AIDS-associated Kaposi's sarcoma. Science. 1994 Dec 16;266(5192):1865-9.

Uldrick TS, Whitby D. Update on KSHV epidemiology, Kaposi Sarcoma pathogenesis, and treatment of Kaposi Sarcoma. Cancer Lett. 2011 Jun 28;305(2):150-62. Epub 2011 Mar 4.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Robert Yarchoan, M.D.
National Cancer Institute (NCI)
BG 10 RM 6N106
10 CENTER DR
BETHESDA MD 20814
(240) 760-6075
robert.yarchoan@nih.gov

Anaida Widell
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 13C438
10 Center Drive
Bethesda, Maryland 20814
(301) 451-3694
awidell@cc.nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT01495598

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