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Investigator(s):
Robert Yarchoan, M.D. Principal Investigator Phone: 301-496-8959 robert.yarchoan@nih.gov	Thomas Uldrick, M.D. Lead Associate Investigator Phone: 301-496-8959 uldrickts@mail.nih.gov	Mark N. Polizzotto, M.B.B.S., BMedSc Associate Investigator Phone: 301-402-1541 mark.polizzotto@nih.gov
Referral Contact(s):
Karen Aleman, R.N., B.S.N. Research Nurse Phone: 301-496-8959 1-800-243-2732 ext. 4 (Toll Free) Fax: 301-402-7552 alemank@mail.nih.gov	Kathy Wyvill, R.N. Research Nurse Phone: 301-496-8959 1-800-243-2732 ext. 4 (Toll Free) Fax: 301-402-7552 wyvillk@mail.nih.gov

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Key Eligibility Criteria:

• Histologically confirmed Kaposi’s sarcoma-associated herpesvirus-associated multicentric Castleman’s disease
• Aged 12 years or older
• No grade IV toxicity unrelated to HIV, its treatment, or multicentric Castleman’s disease that would preclude study therapy
• No other malignancy requiring concurrent treatment that would preclude study therapy or monitoring
• No other condition or circumstance that would preclude study participation

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Study Outline:

Patients are assigned to one of six treatment groups based on disease status.

Group I (observation only)

• Patients with asymptomatic disease undergo observation only, or observation in conjunction with highly active antiretroviral therapy (HAART), where appropriate

Group II (high-dose zidovudine [HDAZT] and valganciclovir [VGCV])

• Patients with symptomatic disease that is not life-threatening receive oral HDAZT four times daily and oral VGCV twice daily on Days 1–21; courses repeat every 21 days

Group III (bortezomib, HDAZT, and VGCV)

• Patients with continued symptomatic disease who are not responding to group II therapy receive bortezomib IV over 3–5 seconds on Days 1, 4, 8, and 11 and HDAZT and VGCV as in group II on Days 1–21
• Courses repeat every 21 days

Group IV (R-EPOCH-R)

• Patients with life-threatening disease will receive R-EPOCH-R therapy comprising a 5-day course of rituximab, etoposide, doxorubicin, vincristine, cyclophosphamide, and prednisone
• Treatment repeats every 21 days for up to 6 courses

Group V

• Patients may also receive rituximab IV and doxorubicin hydrochloride liposome IV for 3 to 6 courses followed by interferon alpha maintenance for 6 to 12 months or high-dose zidovudine and valganciclovir

Group VI

• Patients may also receive oral sirolimus daily with cycle length every 21 days

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, and study outline.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 12/14/12
Updated: 2/21/12