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Treatment for Castleman Disease
Untitled Document
Name of the Trial
Pilot Study of High-Dose Zidovudine and Valganciclovir With or Without Bortezomib
or EPOCH-R (Comprising Etoposide, Doxorubicin, Vincristine, Prednisone, Cyclophosphamide,
and Rituximab) or Observation or HAART Only in Patients With Multicentric Castleman
Disease Associated With Kaposi Sarcoma-Associated Herpesvirus (NCI-04-C-0275).
See the protocol summary.
Principal Investigator
Dr. Richard Little, NCI Center for Cancer Research.
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Dr. Richard Little
Principal Investigator |
Why Is This Trial Important?
Multicentric Castleman disease (MCD) is a rare disorder that causes numerous
problems, including fatigue, fever, anemia, and tumor-like growths in multiple
lymph nodes. Kaposi sarcoma-associated herpesvirus (KSHV), also known as human
herpesvirus 8, is found in about 50% of MCD cases not associated with HIV, and
in nearly 100 percent of HIV-associated MCD. Some patients may also have
Kaposi
sarcoma.
In this trial, symptomatic patients will be treated with high-dose zidovudine
(HDAZT) and valganciclovir. These antiviral drugs are converted into toxic compounds
by KSHV-encoded proteins. These toxic compounds may lead to specific killing
of KSHV-infected cells (MCD tumor cells). Patients who do not respond to this
treatment will also receive the drug bortezomib to see if it can increase the
ability of KSHV to activate HDAZT and valganciclovir and increase tumor cell
death.
Patients with no symptoms will be monitored without therapy for MCD. HIV-infected
patients will receive treatment for HIV, called highly active antiretroviral
therapy or HAART, if appropriate. Patients who develop life-threatening disease
will be treated with conventional chemotherapy (EPOCH-R) to try to bring their
disease and symptoms into remission.
"Laboratory research indicates that certain KSHV genes can activate HDAZT
and valganciclovir to kill tumor cells," said Dr. Little. "If this
approach works in patients with MCD, it may provide the basis for exploring
similar strategies for other viral-associated tumors."
Who Can Join This Trial?
Researchers seek to enroll up to 30 patients aged 12 or over with KSHV-associated
MCD. See the list
of eligibility criteria.
Where Is This Trial Taking Place?
This study is taking place at the NIH Clinical Center in Bethesda, Md.
Contact Information
For more information, call the NCI Clinical Studies Support Center (CSSC) at
1-888-NCI-1937. The call is toll free and confidential.
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