Clinical Trials Logo

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PSC 833 may help chemotherapy drugs kill more cancer cells by making them more sensitive to the drugs.

PURPOSE: Phase II trial to study the effectiveness of PSC 833, daunorubicin, and cytarabine in treating older patients who have newly diagnosed acute myeloid leukemia.


Clinical Trial Description

OBJECTIVES: I. Determine the safety and efficacy of daunorubicin and cytarabine by continuous infusion and PSC 833 in patients over age 56 with newly diagnosed acute myeloid leukemia. II. Determine the frequency and severity of toxicities of this regimen in these patients. III. Determine the frequency and prognosis of functional and phenotypic P-glycoprotein expression, cytogenetics, and pharmacokinetics in this population.

OUTLINE: This is a multicenter study. Patients receive induction chemotherapy consisting of PSC 833 IV over 2 hours on day 1, then continuously for 96 hours; daunorubicin IV continuously on days 1-3; and cytarabine IV continuously on days 1-7. Filgrastim (G-CSF) or sargramostim (GM-CSF) is administered subcutaneously (SQ) or IV beginning on day 15 and continuing until blood counts recover or day 21. If patients do not achieve complete remission after one course, a second course is administered. Patients who achieve A1 bone marrow, B1 peripheral blood, and C1 extramedullary disease status after 1 or 2 courses of induction chemotherapy proceed to consolidation therapy, which begins upon recovery from induction therapy. Consolidation therapy consists of PSC 833 over 2 hours on day 1, daunorubicin IV over 1-5 minutes on days 1 and 2, and cytarabine IV continuously on days 1-5. Treatment repeats for a total of 2 courses. Patients are followed every 6 months for 2 years and then annually for 3 years.

PROJECTED ACCRUAL: A total of 20-55 patients will be accrued for this study within 8-9 months. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00004217
Study type Interventional
Source Southwest Oncology Group
Contact
Status Completed
Phase Phase 2
Start date February 2000
Completion date March 2006

See also
  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