Leukemia Clinical Trial
Official title:
Phase I Trial of Sequential Topotecan(NSC 609699)and Etoposide for Patients With Relapsed, Refractory,or High Risk Acute Myeloid or Lymphoid Leukemia
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of topotecan and etoposide in treating
patients who have recurrent or refractory leukemia.
OBJECTIVES: I. Determine the maximum tolerated dose of topotecan when combined with
etoposide in patients with relapsed or refractory acute myelogenous leukemia, acute
lymphoblastic leukemia, or blastic phase chronic myelogenous leukemia. II. Determine the
toxicity of this regimen in these patients. III. Measure serum levels of topotecan at steady
state and correlate them with any change in topoisomerase II content in leukemic blasts. IV.
Assess whether it is feasible to correlate any upregulation of topoisomerase II expression
with tumor response to etoposide in subsequent Phase II studies. V. Assess whether levels of
pretreatment expression of topoisomerases I and II in leukemic cells are predictive of
clinical response. VI. Assess whether it is feasible to develop a pharmacodynamic assay
based on posttreatment apoptotic changes in leukemic blasts and whether this could be
correlated with tumor response in subsequent phase II trials. VII. Determine the response in
patients treated with this regimen.
OUTLINE: Induction: 2-Drug Combination Chemotherapy. Topotecan, TOPO, NSC-609699; Etoposide,
VP-16, NSC-141540. Consolidation: 2-Drug Combination Chemotherapy. TOPO; VP-16.
PROJECTED ACCRUAL: 15-23 patients will be accrued in approximately 18 months.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05691608 -
MoleculAr Profiling for Pediatric and Young Adult Cancer Treatment Stratification 2
|
N/A | |
| Recruiting |
NCT04092803 -
Virtual Reality as a Distraction Technique for Performing Lumbar Punctures in Children and Young Adu
|
N/A | |
| Active, not recruiting |
NCT02530463 -
Nivolumab and/or Ipilimumab With or Without Azacitidine in Treating Patients With Myelodysplastic Syndrome
|
Phase 2 | |
| Completed |
NCT00948064 -
Vorinostat in Combination With Azacitidine in Patients With Newly-Diagnosed Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS)
|
Phase 2 | |
| Completed |
NCT04474678 -
Quality Improvement Project - "My Logbook! - I Know my Way Around!"; ("Mein Logbuch - Ich Kenne Mich Aus!")
|
N/A | |
| Terminated |
NCT00801931 -
Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03948529 -
RevErsing Poor GrAft Function With eLtrombopag After allogeneIc Hematopoietic Cell trAnsplantation
|
Phase 2 | |
| Completed |
NCT01682226 -
Cord Blood With T-Cell Depleted Haplo-identical Peripheral Blood Stem Cell Transplantation for Hematological Malignancies
|
Phase 2 | |
| Completed |
NCT00003270 -
Chemotherapy, Radiation Therapy, and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT02723994 -
A Phase 2 Study of Ruxolitinib With Chemotherapy in Children With Acute Lymphoblastic Leukemia
|
Phase 2 | |
| Terminated |
NCT02469415 -
Pacritinib for Patients With Lower-Risk Myelodysplastic Syndromes (MDS)
|
Phase 2 | |
| Recruiting |
NCT04856215 -
90Y-labelled Anti-CD66 ab in Childhood High Risk Leukaemia
|
Phase 2 | |
| Recruiting |
NCT06155188 -
Post-transplant PT/FLU+CY Promotes Unrelated Cord Blood Engraftment in Haplo-cord Setting in Childhood Leukemia
|
N/A | |
| Completed |
NCT00001637 -
Immunosuppressive Preparation Followed by Blood Cell Transplant for the Treatment of Blood Cancers in Older Adults
|
Phase 2 | |
| Active, not recruiting |
NCT04188678 -
Resiliency in Older Adults Undergoing Bone Marrow Transplant
|
N/A | |
| Completed |
NCT02910583 -
Ibrutinib Plus Venetoclax in Subjects With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma (CLL/SLL)
|
Phase 2 | |
| Completed |
NCT01212926 -
Early Detection of Anthracycline Cardiotoxicity by Echocardiographic Analysis of Myocardial Deformation in 2D Strain
|
N/A | |
| Terminated |
NCT00014560 -
Antibody Therapy in Treating Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
|
Phase 1 | |
| Recruiting |
NCT04977024 -
SARS-CoV-2 Vaccine (GEO-CM04S1) Versus mRNA SARS-COV-2 Vaccine in Patients With Blood Cancer
|
Phase 2 | |
| Recruiting |
NCT05866887 -
Insomnia Prevention in Children With Acute Lymphoblastic Leukemia
|
N/A |