Cancer Clinical Trial
Official title:
A Strategic Study to Determine the Optimal Moment to Initiate Systemic Antifungal Therapy With Ambisome in Granulocytopenic Cancer Patients With Unexplained Fever Refractory to Empirical Antibacterials
RATIONALE: Liposomal amphotericin B may be effective in controlling fever and
granulocytopenia. It is not yet known which regimen of liposomal amphotericin B is more
effective in treating cancer patients who have these conditions.
PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of
liposomal amphotericin B in treating granulocytopenia and fever in cancer patients.
OBJECTIVES:
- Compare the efficacy and side effects of amphotericin B-liposomal formulation initiated
72-84 hours vs 144-156 hours after onset of a febrile episode in cancer patients with
granulocytopenia and persistent unexplained fever refractory to antibacterials.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
antifungal prophylaxis (yes vs no) and type of underlying condition. Patients are randomized
to 1 of 2 treatment arms.
- Arm I: Patients receive amphotericin B-liposomal formulation IV over 1 hour on day 3 of
febrile neutropenia.
- Arm II: Patients receive amphotericin B-liposomal formulation IV over 1 hour on day 6
of febrile neutropenia.
Treatment continues until signs and symptoms of the fungal infection appear or febrile
neutropenia has resolved. Persistently neutropenic patients receive treatment for at least
10 days or until another cause of infection is determined.
Patients are followed weekly for 3 weeks.
PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study.
;
Allocation: Randomized, Primary Purpose: Supportive Care
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05346796 -
Survivorship Plan HEalth REcord (SPHERE) Implementation Trial
|
N/A | |
| Recruiting |
NCT05094804 -
A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents
|
Phase 1/Phase 2 | |
| Completed |
NCT04867850 -
Effect of Behavioral Nudges on Serious Illness Conversation Documentation
|
N/A | |
| Enrolling by invitation |
NCT04086251 -
Remote Electronic Patient Monitoring in Oncology Patients
|
N/A | |
| Completed |
NCT01285037 -
A Study of LY2801653 in Advanced Cancer
|
Phase 1 | |
| Completed |
NCT00680992 -
Study of Denosumab in Subjects With Giant Cell Tumor of Bone
|
Phase 2 | |
| Completed |
NCT00062842 -
Study of Irinotecan on a Weekly Schedule in Children
|
Phase 1 | |
| Active, not recruiting |
NCT04548063 -
Consent Forms in Cancer Research: Examining the Effect of Length on Readability
|
N/A | |
| Completed |
NCT04337203 -
Shared Healthcare Actions and Reflections Electronic Systems in Survivorship
|
N/A | |
| Recruiting |
NCT04349293 -
Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways
|
N/A | |
| Terminated |
NCT02866851 -
Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy
|
N/A | |
| Active, not recruiting |
NCT05304988 -
Development and Validation of the EFT for Adolescents With Cancer
|
||
| Completed |
NCT04448041 -
CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
|
||
| Completed |
NCT00340522 -
Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
|
||
| Recruiting |
NCT04843891 -
Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis.
|
Phase 1 | |
| Active, not recruiting |
NCT03844048 -
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
|
Phase 3 | |
| Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A | |
| Completed |
NCT03109041 -
Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source
|
Phase 1 | |
| Terminated |
NCT01441115 -
ECI301 and Radiation for Advanced or Metastatic Cancer
|
Phase 1 | |
| Recruiting |
NCT06206785 -
Resting Energy Expenditure in Palliative Cancer Patients
|