This study is NOT currently recruiting participants.
Number
04-C-0275
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)
Fetuses;Children;Adults who are or may become unable to consent;Pregnant Women
Keywords
HHV-8; HIV; Malignancy; Lymphoproliferation; Lymph Node Hyperplasia
Recruitment Keyword(s)
Multicentric Castleman DIsease; MCD; KSHV-MCD; KSHV Associated MCD; HIV; HIV Infections; Herpes Viruses
Condition(s)
Lymphoproliferative Disorder; HHV-8; Malignancy; HIV
Investigational Drug(s)
None
Investigational Device(s)
Intervention(s)
Drug: Etoposide Drug: Interferon-alpha Drug: Rituximab Drug: Zidovudine Drug: Liposomal Doxorubicin Drug: Bortezomib Drug: Valganciclovir Drug: Doxorubicin Drug: Vincristine Drug: Cyclophosphamide Drug: Filgrastim (G-CSF) Drug: Prednisone Drug: Sirolimus Other: Observation Only
Supporting Site
National Cancer Institute
Participants ages 18 and older may be eligible for this study. Participation entails more drawing of blood and having repeated tumor biopsies than if patients received treatment in a non-research setting. Researchers would like to learn more about the relationship of KSHV and Castleman s disease symptoms, and they want to obtain at least three biopsies in this study.
There are some side effects of experimental therapy that participants may take for KSHV-MCD. Zidovudine, or Retrovir , is used at a high dose. It is given orally or through a vein, four times daily, for 7 days or longer. Zidovudine can cause nausea, vomiting, decreased bone marrow function, and decreased blood counts. Combined with valganciclovir, or Valcyte , it is likely to be more toxic to bone marrow. Valganciclovir can cause problems with bone marrow function, leading to low blood counts, sterility, and defects in a fetus. Combined with zidovudine, valganciclovir may cause more toxicity to the bone marrow. It is given twice daily for 7 days or longer. Bortezomib, or Velcade , is given for a few seconds by a rapid push through a needle into the vein. It is given twice weekly for four doses and then stopped for 1 week. Bortezomib can sometimes cause low blood pressure; it also can cause gastrointestinal problems and a low blood platelet count. Rituximab and liposomal doxorubicin are drugs given by a catheter into a vein. Interferon-alpha is given by injection into the skin. Those drugs are not experimental, but their use in Castleman s disease is experimental.
Some participants may be treated with a combination of chemotherapy followed by interferon-alpha. Interferon-alpha is infected into the skin by a needle. The natural form of interferon is produced by the body and helps to control viral infections. KSHV decreases the effect of the body s interferon, and the researchers want to see if giving higher doses of interferon will help to control KSHV infection.
A positron emission tomography (PET) scan, for research purposes only, may be done up to three times a year. A radioactive sugar molecule called fluorodeoxyglucose, or FDG, is used. It is believed that activated lymphocytes that may be found in participants disease might use more FDG because these cells burn more glucose fuel.
This study may or may not have a direct benefit for participants. However, detailed assessments made throughout the study may provide information to help the doctors treat KSHV-MCD better.
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INCLUSION CRITERIA: Age greater than or equal to 18 years. Biopsy proven KSHV-associated MCD, confirmed in the Laboratory of Pathology, CCR. Willing to give informed consent. EXCLUSION CRITERIA: Any abnormality that would be scored as NCI CTC Grade IV toxicity that is unrelated to HIV, its treatment, or to MCD that would preclude protocol treatment and/or observation only. Presence of another malignancy requiring current treatment that would preclude the use of all of the study treatments or the ability to monitor the natural history of MCD untreated. Pregnant women are excluded from this study as certain of the study agents have the potential for teratogenic effects Any condition or set of circumstances that in the opinion of the investigators would make participation in this study unsafe or otherwise inappropriate for a given individual.
Age greater than or equal to 18 years.
Biopsy proven KSHV-associated MCD, confirmed in the Laboratory of Pathology, CCR.
Willing to give informed consent.
EXCLUSION CRITERIA:
Any abnormality that would be scored as NCI CTC Grade IV toxicity that is unrelated to HIV, its treatment, or to MCD that would preclude protocol treatment and/or observation only.
Presence of another malignancy requiring current treatment that would preclude the use of all of the study treatments or the ability to monitor the natural history of MCD untreated.
Pregnant women are excluded from this study as certain of the study agents have the potential for teratogenic effects
Any condition or set of circumstances that in the opinion of the investigators would make participation in this study unsafe or otherwise inappropriate for a given individual.
Principal Investigator
Referral Contact
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