Edetate Calcium Disodium or Succimer in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome Undergoing Chemotherapy

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    20
  • sponsor
    M.D. Anderson Cancer Center
Updated on 3 February 2021
cancer
calcium
tubal ligation
chronic myeloid leukemia
myeloid leukemia
blast crisis
myeloproliferative disorder
leukemia
bone marrow procedure
refractory acute myeloid leukemia (aml)
secondary acute myeloid leukemia
succimer
myelodysplastic/myeloproliferative neoplasm

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)
Treatment Multivitamin, Edetate Calcium Disodium, Edetate Calcium Disodium, DMSA, Succimer, Succimer
Clinical Study IdentifierNCT03630991
SponsorM.D. Anderson Cancer Center
Last Modified on3 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: secondary aml or Secondary Acute Myeloid Leukemia or Myelodysplastic-Myeloproliferative Diseases or Recurrent Myelodysplastic Syndrome or myelodysplas...?
Do you have any of these conditions: Blast Crisis or myeloproliferative disorders or High Risk Myelodysplastic Syndrome or refractory acute myeloid leukemia (aml) or secondary aml or Refr...?
Understand and voluntarily sign an informed consent form
Diagnosis of newly diagnosed or untreated AML with poor-risk cytogenetics, poor-risk molecular, or secondary AML (i.e. therapy-related or evolved from antecedent hematologic malignancy. Newly diagnosed (or untreated) myeloid blast phase of myeloproliferative neoplasm (MPN) (including myeloid blast phase of chronic myeloid leukemia [CML]). Newly diagnosed (or untreated) high-risk, very-high risk or secondary MDS. Newly diagnosed (or untreated) MDS/MPN (regardless of cytogenetic/molecular status). Relapsed and/or refractory AML, MDS, MDS/MPN, myeloid blast phase of MPN (including myeloid blast phase of CML) who are either salvage 1 or salvage 2
Patients on non-investigational regimens or on investigational new drug (IND)-exempt MD Anderson studies of approved drugs are also eligible
Transformed and untreated AML transformed from previously treated MDS, myeloproliferative neoplasm (MPN) or other types of secondary AML are allowed. Myeloid-blast phase of MPN and chronic myeloid leukemia (CML) are allowed
Eastern Cooperative Oncology Group (ECOG) performance status of =< 2 at study entry
Serum creatinine =< 1.5 mg/dL
Total bilirubin =< 2.0 x upper limit of normal (ULN), unless the patient has Gilbert's
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and/or alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.0 x ULN
Women of childbearing potential (WCBP) must have a negative urine pregnancy test within 7 days and must either commit to continued abstinence from heterosexual intercourse or adopting at least one highly effective method of contraception. These methods include intra-uterine device, tubal ligation, partner's vasectomy, and hormonal birth control pills. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential
Extramedullary disease is allowed as long as it can be measured and followed for response

Exclusion Criteria

Nursing and pregnant females. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Uncontrolled inter-current illness including, but not limited to, uncontrolled active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements or which judged by the investigator, places the patient at unacceptable risk
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