Sarcoma Clinical Trial
Official title:
Pilot Study of Viral Load and Transcription in Kaposi's Sarcoma Patients Treated With Liposomal Anthracyclines
RATIONALE: Drugs used in chemotherapy, such as liposomal daunorubicin, work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing.
PURPOSE: This clinical trial is studying how well liposomal daunorubicin works in treating
patients with HIV-related Kaposi's sarcoma.
OBJECTIVES:
Primary
- Determine the effect of liposomal daunorubicin citrate on Kaposi's sarcoma-associated
herpes virus (KSHV) viral gene expression in tumors of patients with HIV-related
Kaposi's sarcoma.
Secondary
- Determine the effect of this drug on KSHV viral gene expression in peripheral blood
mononuclear cells.
- Determine the effect of this drug on KSHV viral load in plasma.
- Correlate viral load with viral gene expression and/or tumor regression in these
patients.
OUTLINE: This is a multicenter, pilot study.
Patients receive liposomal daunorubicin citrate IV days 1 and 15. Treatment repeats every 4
weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity.
Biopsies are performed at baseline and once during treatment to evaluate Kaposi's sarcoma-
associated herpes virus (KSHV) viral gene expression in tumors and skin tissue using reverse
transcriptase-quantitative polymerase chain reaction. Blood samples are collected at
baseline and periodically during treatment to evaluate KSHV viral gene expression in
peripheral blood mononuclear cells and viral load in plasma.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
;
Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04986748 -
Using QPOP to Predict Treatment for Sarcomas and Melanomas
|
||
| Recruiting |
NCT04457258 -
68Ga-FAPi-46 PET/CT Scan in Imaging Patients With Sarcoma
|
Early Phase 1 | |
| Completed |
NCT04474678 -
Quality Improvement Project - "My Logbook! - I Know my Way Around!"; ("Mein Logbuch - Ich Kenne Mich Aus!")
|
N/A | |
| Recruiting |
NCT05415098 -
Study of Safety, Pharmacokinetic and Efficacy of APG-5918 in Advanced Solid Tumors or Lymphomas
|
Phase 1 | |
| Recruiting |
NCT04535713 -
GALLANT: Metronomic Gemcitabine, Doxorubicin, Docetaxel and Nivolumab for Advanced Sarcoma
|
Phase 2 | |
| Completed |
NCT03521531 -
Burden and Medical Care of Sarcoma in Germany
|
||
| Completed |
NCT02496520 -
Dendritic Cell-based Immunotherapy for Advanced Solid Tumours of Children and Young Adults
|
Phase 1/Phase 2 | |
| Terminated |
NCT02054104 -
Adjuvant Tumor Lysate Vaccine and Iscomatrix With or Without Metronomic Oral Cyclophosphamide and Celecoxib in Patients With Malignancies Involving Lungs, Esophagus, Pleura, or Mediastinum
|
Phase 1/Phase 2 | |
| Terminated |
NCT00788125 -
Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT04577014 -
Retifanlimab (Anti-PD-1 Antibody) With Gemcitabine and Docetaxel in Patients With Advanced Soft Tissue Sarcoma
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
| Completed |
NCT04052334 -
Lymphodepletion Plus Adoptive Cell Therapy With High Dose IL-2 in Adolescent and Young Adult Patients With Soft Tissue Sarcoma
|
Phase 1 | |
| Completed |
NCT01593748 -
A Phase II Trial Comparing Gemcitabine and Pazopanib Versus Gemcitabine and Docetaxel for Patients With Advanced Soft Tissue Sarcoma
|
Phase 2 | |
| Completed |
NCT00199849 -
NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine
|
Phase 1 | |
| Recruiting |
NCT04367779 -
Research of Biomarkers of Response to Proton Beam Therapy in Pediatric and Adult Patients.
|
||
| Completed |
NCT01879085 -
Study of Vorinostat in Combination With Gemcitabine and Docetaxel in Advanced Sarcoma
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04553692 -
Phase 1a/1b Study of Aplitabart (IGM-8444) Alone or in Combination in Participants With Relapsed, Refractory, or Newly Diagnosed Cancers
|
Phase 1 | |
| Completed |
NCT01209598 -
PD0332991 (Palbociclib) in Patients With Advanced or Metastatic Liposarcoma
|
Phase 2 | |
| Completed |
NCT04553471 -
Palliative Lattice Stereotactic Body Radiotherapy (SBRT) for Patients With Sarcoma, Thoracic, Abdominal, and Pelvic Cancers
|
N/A | |
| Withdrawn |
NCT04906876 -
A Phase 2 Study of 9-ING-41Combined With Chemotherapy in Adolescents and Adults With Advanced Sarcomas
|
Phase 2 |