Edetate Calcium Disodium or Succimer in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome Undergoing Chemotherapy
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- STATUS
- Recruiting
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- End date
- Dec 31, 2021
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- participants needed
- 20
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- sponsor
- M.D. Anderson Cancer Center
Summary
This phase I trial studies the side effects and best dose of edetate calcium disodium or succimer in treating patients with acute myeloid leukemia or myelodysplastic syndrome undergoing chemotherapy. Edetate calcium disodium or succimer may help to lower the level of metals found in the bone marrow and blood and may help to control the disease and/or improve response to chemotherapy.
Description
PRIMARY OBJECTIVES:
I. To establish the maximal tolerated dose (MTD) of two Phase 1 cohorts (cohort receiving succimer [DMSA] and cohort receiving edetate calcium disodium [Ca-EDTA]) in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) patients undergoing therapy combined with DMSA and Ca-EDTA.
SECONDARY OBJECTIVES:
I. To assess the complete remission (CR) rate and the 1-year overall survival (OS) rate in AML patients and the CR rate, partial remission (PR) rate and 6-month cytogenetic response in MDS patients undergoing MDS/AML therapy combined with DMSA and Ca-EDTA.
II. To assess overall survival in AML and MDS patients undergoing AML and MDS therapy combined with DMSA and Ca-EDTA.
III. To assess remission duration in AML and MDS patients undergoing AML and MDS therapy combined with DMSA and Ca-EDTA.
IV. To monitor toxic and essential metal levels during AML and MDS therapy combined with DMSA and Ca-EDTA and to evaluate the reduction in metals in the bone marrow and blood of newly diagnosed AML and MDS patients undergoing metal detoxification combined with standard AML/MDS therapy.
V. To evaluate the safety profile in AML and MDS patients undergoing AML and MDS therapy combined with DMSA and Ca-EDTA.
VI. Correlate metal and copper isotopic abundance ratios of AML and MDS patients with clinical data, conventional cytogenetics, extensive next generation sequencing (NGS) (300-gene panel), exposure survey data, and clinical outcome data.
VII. Estimate the progression rate in MDS patients.
EXPLORATORY OBJECTIVES:
I. To correlate the degree of metal chelation with the degree of therapeutic response and minimal residual disease (MRD).
II. To collect environmental exposure data on the environmental health assessment survey.
III. To assess P53 folding before and after the first dose of Ca-EDTA chelation in MDS and AML patients.
OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 2 cohorts.
COHORT I: During standard of care chemotherapy, patients receive edetate calcium disodium intravenously (IV) over 30 minutes for 4 doses for each cycle. Treatment continues for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive up to 12 multivitamin capsules PO daily while on study.
COHORT II: During standard of care chemotherapy, patients receive succimer orally (PO) for 8 days of each cycle. Treatment continues for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive up to 12 multivitamin capsules PO daily while on study.
After completion of study treatment, patients are followed up every 3-12 months for up to 10 years.
Details
| Condition | Blast Crisis, Bone marrow disorder, Chronic myelomonocytic leukemia, Preleukemia, Acute myeloid leukemia, Myelodysplastic-Myeloproliferative Diseases, MYELOPROLIFERATIVE DISORDER, MYELODYSPLASTIC SYNDROME, Chronic myeloid leukemia, Myelodysplastic Syndromes (MDS), Acute Myelogenous Leukemia (AML), Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Secondary Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia, Myeloproliferative Neoplasms, High Risk Myelodysplastic Syndrome, Recurrent Acute Myeloid Leukemia, Recurrent Myelodysplastic Syndrome, Refractory Myelodysplastic Syndrome, AML/MDS, myelodysplastic syndromes, myeloproliferative neoplasm, myeloproliferative disorders, myelodysplastic syndrome (mds), secondary aml, acute myelogenous leukemia, anll, acute myeloblastic leukemia, refractory acute myeloid leukemia (aml) |
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| Treatment | Multivitamin, Edetate Calcium Disodium, Edetate Calcium Disodium, DMSA, Succimer, Succimer |
| Clinical Study Identifier | NCT03630991 |
| Sponsor | M.D. Anderson Cancer Center |
| Last Modified on | 3 February 2021 |
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