Leukemia Clinical Trial
Official title:
A Pilot Clinical Trial of Mitomycin C Modulation of Multidrug Resistance Proteins and a Phase I Evaluation of Mitomycin C and Mitoxantrone in Patients With Acute Myelogenous Leukemia
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Some cancers become resistant to chemotherapy drugs. Combining
mitomycin with a chemotherapy drug may reduce resistance to the drug and allow the cancer
cells to be killed.
PURPOSE: Phase I trial to study the effectiveness of mitomycin and mitoxantrone in treating
patients with acute myelogenous leukemia and to determine whether mitomycin can reduce the
cancer's resistance to chemotherapy.
OBJECTIVES: I. Determine whether a single mitomycin C treatment will suppress expression of
one or more proteins associated with the multidrug resistance phenotype in leukemia cells of
patients with refractory acute myelogenous leukemia. II. Determine the maximum tolerated dose
of a combination of mitomycin C followed 72 hours later by a single dose of mitoxantrone in
patients with acute myelogenous leukemia with GM-CSF support. III. Determine the toxicity
profile and pharmokinetics for these combinations of mitomycin C and mitoxantrone. IV.
Determine the ability of this regimen to induce complete response in patients with primary
resistant or refractory acute myelogenous leukemia.
OUTLINE: Patients receive mitomycin C by IV bolus on day 1 of treatment. Patients receive
mitoxantrone beginning on day 4. One patient each is entered at the first and second dose
levels. Dose escalation of mitoxantrone continues in the absence of toxicity. If the patient
experiences toxicity at level 1 or 2, then 2 additional patients are entered at that tier.
Three patients are entered at all subsequent tiers. At these tiers, if no toxicity is
observed, escalation continues. If 1 of the 3 patients experiences toxicity, an additional 3
patients are enrolled at the same dose. If none of these additional patients experiences
toxicity, escalation continues; however, if 1 patient has toxicity, the trial is stopped. If
2 or more have toxicities, the dose is de-escalated. If 2 or more of the original 3 patients
have toxicities, the dose is de-escalated. On day 15, patients are treated with sargramostim
(GM-CSF) intravenously over 4 hours if the bone marrow is free of residual leukemia; GM-CSF
treatment continues until the ANC is greater than 1,500/mm3 for 3 consecutive days.
PROJECTED ACCRUAL: For the pilot study of mitomycin C modulation of multidrug resistance
proteins, 12 patients will be accrued. For the phase I study of mitomycin C and mitoxantrone,
at least 17 patients will be entered.
;
| 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 |