Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

October 28, 2004

Primary Completion Date

October 1, 2026

Study Completion Date

October 1, 2026

Conditions
Lymphoproliferative DisorderHHV-8MalignancyHIV
Interventions
DRUG

Etoposide

Etoposide 50 mg/m2 /day continuous intravenous infusion (CIVI) over 24 hours x 4 days (days 1-4) of 21 day cycle. A maximum of 6 cycles of R-EPOCH-R will be administered except in exceptional circumstances.

DRUG

Interferon-alpha

Ages 18 and over: Initial dose of 7.5 million units subcutaneous, three times weekly x 14 days; subsequent dosesincrease dose as tolerated each 14 days to a maximum of 45 million units subcutaneous three times weekly; Ages 12-17: Initial dose of 5 million units/m2 subcutaneous, three times weekly x 14 days Subsequent doses: Increase dose as tolerated each 14 days to a maximum of 30 million units/m2 subcutaneous, three times weekly

DRUG

Rituximab

Rituximab 375 mg/m2 IV day 1, shall be administered prior to Doxil injection. When combined with EPOCH chemotherapy, Rituximab will be given on days 1 and 5.

DRUG

Zidovudine

Cycle 1: Zidovudine 600 mg PO QID x 7-21 days in outpatient setting;600 mg PO q6hours x 7-21 (Intravenous zidovudine 300 mg q 6 hours may be substituted) days for inpatients; Cycle 2 and beyond: 600 mg PO QID x 7 days in outpatient setting; 600 mg PO q 6 hours x 7 days (300 mg q 6 hours may be substituted)

DRUG

Liposomal Doxorubicin

21 day cycle; 20 mg/m2 Liposomal Doxorubicin given on day 1 and shall be administered after completion of Rituximab infusion from 2 to 6 cycles.

DRUG

Bortezomib

1.3 mg/m2 IV days 1, 4, 8, and 11. Cycle length is 21 days.

DRUG

Valganciclovir

Cycle 1: Valganciclovir 900 mg PO BID x 7-21 days in outpatient setting; 900 mg PO q 12 hours x 7-21 days for inpatients; Cycle 2 and beyond: 900 mg PO BID x 7 days for outpatients; 900 mg PO q 12 hours x 7 days (Intravenous ganciclovir 5 mg/kg may be substituted) for inpatients

DRUG

Doxorubicin

10 mg/m2 /day CIVI over 24 hours x 4 days (days 1-4) of 21 day cycle.

DRUG

Vincristine

0.4 mg/m2 /day CIVI over 24 hours x 4 days (days 1-4) of 21 day cycle.

DRUG

Cyclophosphamide

Cyclophosphamide: if CD4 \< 100 cells/mm3, 187 mg/m2 IV (Day 5) if CD4 greater than or equal to 100 cells/mm3, 375 mg/m2 IV (Day 5) of 21 day cycle.

DRUG

Filgrastim (G-CSF)

Filgrastim 300 micrograms subcutaneous daily beginning day 6 until absolute neutrophil count recovery 5000 cells/mm3 (Pegfilgrastim may be substituted with PI approval, at the recommended dose of one 6mg syringe)

DRUG

Prednisone

Prednisone 60 mg/m2/day PO x 5 days (days 1-5)of 21 day cycle.

DRUG

Sirolimus

Maximum daily dose of 40 mg given as a single agent on 21 day cycle.

OTHER

Observation Only

Observation of symptoms

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH