Status:
COMPLETED
Tocilizumab for KSHV-Associated Multicentric Castleman Disease
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Castleman Disease
Multicentric Castleman Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Background: \- Kaposi's sarcoma-associated herpes virus (KSHV)-associated multicentric Castleman disease (KSHV-MCD) is caused by a herpes virus known as KSHV. This disease can also cause several othe...
Detailed Description
BACKGROUND: * Kaposi sarcoma herpesvirus-associated multicentric Castleman disease (KSHVMCD) is a rare lymphoproliferative disorder that develops predominantly in human immunodeficiency deficiency vi...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Pathologically confirmed Kaposi sarcoma (KS)-associated herpes virus multi-centric Castleman disease (KSHV-MCD)
- Age greater than or equal to 18
- At least one clinical symptom probably or definitely attributed to KSHV-MCD
- Intermittent or persistent fever for at least 1 week (\>38 degrees C)
- Fatigue (Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or greater)
- Gastrointestinal symptoms \[includes nausea and anorexia\] (CTCAE Grade 1 or greater)
- Respiratory symptoms \[includes cough and airway hyperreactivity\]
- (CTCAE Grade 1 or greater)
- At least one laboratory abnormality probably or definitely attributed to KSHVMCD
- Anemia (Hgb \[men\] \</=12.5 gm/dL, Hgb \[women\] \</= 11 gm/dL)
- Thrombocytopenia (\</=130,000/mm(3))
- Hypoalbuminemia (\<3.4 g/dl)
- Elevated C-reactive protein (CRP) (CRP \> 3 mg/L)\] probably or definitely attributable to KSHV-MCD
- No life- or organ-threatening manifestations of MCD
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
- Human Immunodeficiency Virus (HIV)-infected patients should be receiving or willing to initiate an effective combination antiretroviral therapy (cART) regimen
- Willingness to complete tuberculosis evaluation and start prophylactic antituberculosis therapy as soon as is medically feasible if patients have a reactive tuberculin skin test and have not completed an adequate course of prevented anti-tuberculosis therapy, following American Thoracic Society/ Centers for Disease Control recommended guidelines:
- http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5231a4.htm
- Ability to understand and willingness to give informed consent
- Women of child bearing potential must agree to use birth control for the duration of the study
- EXCLUSION CRITERIA:
- Uncontrolled bacterial, mycobacterial, or fungal infection
- Uncontrolled intercurrent illness including, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or ability to receive therapy.
- Pregnant or lactating women
- Any abnormality that would be scored as National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grade 3 toxicity that is unrelated to HIV, its treatment, or to MCD that would preclude protocol treatment. Exceptions include:
- Lymphopenia
- Direct manifestations of Kaposi sarcoma or MCD
- Direct manifestation of HIV (i.e. low cluster of differentiation 4 (CD4) count)
- Direct manifestation of HIV therapy (i.e. Hyperbilirubinemia associated with protease inhibitors)
- Asymptomatic hyperuricemia
- Hypophosphatemia
- Elevated creatine kinase (CK) attributed to exercise
- Past or present history of malignant tumors other than Kaposi sarcoma unless one of the following:
- Complete remission for greater than or equal to 1 year from completion of therapy
- Completely resected basal cell carcinoma
- In situ squamous cell carcinoma of the cervix or anus
- Patients with concurrent Kaposi sarcoma requiring immediate cytotoxic chemotherapy
- History of tocilizumab therapy within prior three months
- History of rituximab or bevacizumab therapy within three months
- History of greater than or equal to 2 allergic reaction or any grade anaphylactic reaction during prior administration of tocilizumab
Exclusion
Key Trial Info
Start Date :
September 13 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 5 2020
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01441063
Start Date
September 13 2011
End Date
October 5 2020
Last Update
October 27 2020
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892