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Monitoring, Detoxifying, and Rebalancing Metals During Front Line Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Therapy

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ClinicalTrials.gov Identifier: NCT03630991
Recruitment Status : Recruiting
First Posted : August 15, 2018
Last Update Posted : February 18, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

If you are reading and signing this form on behalf of a potential participant, please note: Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant.

The goal of this clinical research study is to learn if giving calcium disodium edetate (Ca-EDTA) or dimercaptosuccinic acid (DMSA) to patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) while receiving standard chemotherapy can help to lower the level of metals found in the bone marrow and blood. Researchers think lowering the level of metals found in the blood/bone marrow may help to control the disease and/or improve response to chemotherapy.

Researchers also want to find the highest tolerable dose of Ca-EDTA and DMSA that can be given to AML or MDS patients.

The safety of Ca-EDTA and DMSA will also be studied.

This is an investigational study. Ca-EDTA and DMSA are both FDA approved and commercially available as metal detoxifiers (medications that lower the amount of metals in the blood). It is considered investigational to give Ca-EDTA and DMSA to patients with AML/MDS who are receiving chemotherapy.

Up to 24 participants will be enrolled in this study. All will take part at MD Anderson.


Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome Chronic Myelogenous Leukemia, BCR-ABL1 Positive Chronic Myelomonocytic Leukemia Myelodysplastic Syndrome Myelodysplastic/Myeloproliferative Neoplasm Secondary Acute Myeloid Leukemia Drug: Edetate Calcium Disodium Dietary Supplement: Multivitamin Drug: DMSA Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Monitoring, Detoxifying, and Rebalancing Metals During Front Line Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Therapy
Actual Study Start Date : October 11, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020


Arm Intervention/treatment
Experimental: Ca-EDTA Group

Participants receive Ca-EDTA by vein over about 30 minutes before dose of chemotherapy.

Participants given a daily multivitamin (which is made up of Vitamins C, E, K, B6, and B12 and thiamin, riboflavin, niacin, pantothenic acid, folate, biotin, choline, inositol, rubidium, selenium, zinc, and magnesium) and/or standard drugs while on study. Participants take up to 12 multivitamin capsules every day while on study.

Drug: Edetate Calcium Disodium
The target dose of Ca-EDTA is 1g/m2. The intended starting dose is at the -1 dose level (0.75 g/m2).
Other Names:
  • C10H12CaN2Na2O8
  • Calcium disodium edetate
  • Calcium disodium ethylenediaminetetraacetate
  • Calcium Disodium Versenate
  • Calcium EDTA
  • Disodium calcium ethylenediaminetetraacetate
  • EDTA Calcium

Dietary Supplement: Multivitamin
Given PO
Other Names:
  • Geritol
  • Vitamin Supplements (NOS)

Experimental: DMSA Group

Participants take DMSA by mouth every day for 8 days as directed by the study doctor.

Participants given a daily multivitamin (which is made up of Vitamins C, E, K, B6, and B12 and thiamin, riboflavin, niacin, pantothenic acid, folate, biotin, choline, inositol, rubidium, selenium, zinc, and magnesium) and/or standard drugs while on study. Participants take up to 12 multivitamin capsules every day while on study.

Dietary Supplement: Multivitamin
Given PO
Other Names:
  • Geritol
  • Vitamin Supplements (NOS)

Drug: DMSA
The target dose is 500 mg (approx. 350 mg/m2). In the dose escalation phase, starting at dose level -1(up to a maximum of 250 mg, approx. 175 mg/m2).
Other Names:
  • Chemet
  • Meso 2, 3-Dimercaptosuccinic Acid
  • SUCCIMER




Primary Outcome Measures :
  1. Cytogenetic response (myelodysplastic syndrome patients) [ Time Frame: At 6 months ]
    The optimum two-stage design proposed by Simon will be implemented.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Understand and voluntarily sign an informed consent form.
  2. Age >/= 18 years at the time of signing the informed consent form.
  3. 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 MPN (including myeloid blast phase of 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.
  4. Patients on non-investigational regimens or on IND-exempt MD Anderson studies of approved drugs are also eligible.
  5. 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
  6. Eastern Cooperative Oncology Group (ECOG) performance status of </= 2 at study entry
  7. Laboratory test results within these ranges (unless due to leukemia or other hematologic malignancy): a) Serum creatinine </= 1.5 mg/dL; b) Total Bilirubin </=2.0 x upper limit of normal (ULN), unless the patient has Gilbert's; c) AST (SGOT) and/or ALT (SGPT) </= 2.0 x ULN.
  8. 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.
  9. Extramedullary disease is allowed as long as it can be measured and followed for response.

Exclusion Criteria:

  1. 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.
  2. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03630991


Contacts
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Contact: Maro Ohanian 713-792-2631 mohanian@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact       mohanian@mdanderson.org   
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Maro Ohanian M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03630991     History of Changes
Other Study ID Numbers: 2017-0752
NCI-2018-01610 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2017-0752 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Syndrome
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Preleukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myelomonocytic, Chronic
Leukemia, Myelomonocytic, Juvenile
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Disease
Pathologic Processes
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Vitamins
Pantothenic Acid
Calcium
Calcium, Dietary
Edetic Acid
Pentetic Acid
Succimer
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents