Virotherapy for Castleman Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores new treatments for KSHV-associated multicentric Castleman's disease (MCD), a rare and potentially life-threatening condition linked to a virus. The study tests various treatments, including drugs like zidovudine, which can affect blood cells, and valganciclovir, which may impact bone marrow, to determine their effectiveness in managing the disease. Additionally, the trial includes virotherapy, a treatment that uses viruses to target and destroy cancer cells. Individuals diagnosed with KSHV-MCD who are willing to undergo blood draws and tumor biopsies might be suitable candidates. The trial aims to enhance understanding of the disease and improve future treatments, though direct benefits to participants are not guaranteed. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, since the study involves experimental treatments, it's best to discuss your current medications with the study team to ensure safety and compatibility.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that various treatments for KSHV-associated multicentric Castleman disease (MCD) have been tested for safety in people. High doses of zidovudine and valganciclovir can cause side effects such as nausea, vomiting, and bone marrow issues, leading to lower blood counts. This combination may be more harmful to the bone marrow when used together.
Bortezomib, combined with zidovudine and valganciclovir, might cause low blood pressure and stomach problems. Previous studies found that rituximab with liposomal doxorubicin is generally safe for most patients, with mild to moderate side effects like infections. This combination has effectively treated symptoms of KSHV-MCD.
Sirolimus has also shown promise in other studies. It has been tested for long-term safety and is being considered as a new treatment option for related conditions.
In summary, while these treatments can have side effects, studies have provided important safety information. Participants should weigh both the potential benefits and risks of joining the trial.12345Why are researchers excited about this trial's treatments?
Unlike the standard treatments for Castleman Disease, which often involve chemotherapy and immunotherapy, virotherapy offers a novel approach by harnessing viruses to target and destroy abnormal cells. Researchers are excited about virotherapy because it specifically targets diseased cells without affecting healthy ones, potentially reducing side effects commonly associated with traditional treatments. Additionally, virotherapy could enhance the immune system's ability to fight the disease, providing a two-pronged attack that is both direct and supportive. This innovative mechanism of action sets virotherapy apart from the usual treatment options and holds promise for more effective and gentler management of Castleman Disease.
What evidence suggests that this trial's treatments could be effective for Castleman Disease?
Research has shown that there isn't a one-size-fits-all treatment for KSHV-associated multicentric Castleman's disease (KSHV-MCD), a serious condition often linked to Kaposi's sarcoma herpesvirus (KSHV). In this trial, one group receives high doses of zidovudine and valganciclovir, which typically delayed disease progression for 6 months, with 86% of patients surviving after a year. Another group uses sirolimus, effective for similar conditions and generally well-tolerated. A separate group combines EPOCH chemotherapy with rituximab, benefiting 77% of patients, with more than half achieving complete remission. Additionally, another group studies rituximab with liposomal doxorubicin, showing significant improvement in patients with extensive prior treatments. These treatments are under study for their potential to manage KSHV-MCD, but results can vary among individuals.678910
Who Is on the Research Team?
Robert Yarchoan, M.D.
Principal Investigator
National Cancer Institute (NCI)
Are You a Good Fit for This Trial?
Adults over 18 with biopsy-proven KSHV-associated multicentric Castleman's disease can join this study. Pregnant women and individuals with severe unrelated health issues, other active malignancies needing treatment, or conditions making the trial unsafe are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive various treatments including high-dose zidovudine, valganciclovir, bortezomib, sirolimus, rituximab with liposomal doxorubicin, and EPOCH chemotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Natural History Observation
Participants are observed to study and describe the natural history of KSHV-MCD
What Are the Treatments Tested in This Trial?
Interventions
- Bortezomib
- Cyclophosphamide
- Doxorubicin
- Etoposide
- Interferon-alpha
- Liposomal Doxorubicin
- Prednisone
- Rituximab
- Valganciclovir
- Virotherapy
- Zidovudine
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor