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Sodium stibogluconate 900 mg/m2/day will be given on d1-5 and d15-19. 28 days per cycle.

Sodium stibogluconate

Hui Zeng, MD

Huien Zhan, MD

Min Lu, PHD

To evaluate the safety and effectiveness of Sodium Stibogluconate in the treatment of myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) with p53 mutation from a defined list. The list includes 65 p53 mutations that were experimentally confirmed to be pharmacologically restored with tumor-suppressive function by antimonials.

p53 is inactivated by over hundreds of diverse mutations in cancer. The investigator purposefully selected the phenotype-reversible temperature-sensitive (TS) p53 mutations for pharmacological rescue, and pertinently used p53 thermostability as readout to screen for TS p53 mutation rescue compounds. By this, the investigator identified antiparasitic drug antimonials efficiently thermostabilized the TS mutants by noncovalent binding. The antimonials met the three go-to criteria as a targeted drug-availability of co-crystal structure, structure model-compatible Structure-Activity Relationship, and target (p53)-specificity in cells, and consequently extended survival of xenograft mouse with TS p53 mutant.

Under the clinical antiparasitic dosage, the antimonials effectively rescued TS p53 mutant in patient-derived primary acute myeloid leukemia cells. Scan of the most frequent 815 p53 missense mutations identified 65 of them, predominantly TS mutations, as the antimonial-treatable mutations. Thus, the trial aims to evaluate the safety and effectiveness of the approved antimonial-Sodium Stibogluconate-in the treatment of myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) with the 65 antimonial-treatable p53 mutants.

Sodium Stibogluconate in the MDS/AML With One of the 65 Defined p53 Mutations

Sodium Stibogluconate in the Myelodysplastic Syndromes/Acute Myeloid Leukemia With One of the 65 Defined p53 Mutations That Can be Functionally Rescued by Sodium Stibogluconate

Partial response (PR) + complete response (CR) rate

Adverse events (AEs) will be reported and graded

Ruijin Hospital

First Affiliated Hospital of Jinan University

Director of Hematology Department of the First Affiliated Hospital of Jinan University

Sodium stibogluconate 900 mg/m2/day will be given on Monday through Friday every other week for the first 16 weeks of the study (on the 1st, 3rd, 5th, 7th, 9th, 11th, 13th and 15th weeks). On the alternate weeks patients will not receive any study treatment.

sodium stibogluconate

Elizabeth Eklund, MD

Sodium stibogluconate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

This was originally designed as a phase I/II trial studying the side effects of sodium stibogluconate and how well it works in treating patients with myelodysplastic syndromes. Unfortunately, due to funding issues, the phase II portion was never conducted.

Patients receive sodium stibogluconate IV over 30 minutes on days 1-5 and 15-19. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients who respond to treatment may continue therapy until disease progression.

Patients undergo bone marrow aspiration, biopsy, and peripheral blood sample collection periodically for correlative laboratory studies.

After completion of study treatment, patients are followed up at 8 weeks.

The phase II portion of this trial was never conducted due to lack of funding.

Phase I/II Trial of Sodium Stibogluconate in Myelodysplastic Syndrome

SHP2 as a Therapeutic Target For Myelodysplastic Syndrome: Phase I/II Trial of Sodium Stibogluconate in Myelodysplastic Syndrome

To determine the effect of SSG treatment on clinical parameters of MDS. This will include determination of cytopenias, bone marrow dysplasia, % myeloid blasts, transfusion frequency, incidence of infection and phagocyte function in MDS subjects pre and during treatment. Serum Sb levels will also be determined as an early indication of toxicity.

To determine the effect of SSG treatment on hematopoiesis in MDS subjects. This will include determination of cytokine hypersensitivity, apoptosis resistance, and altered expression of key HoxA10 and ICSBP target genes in the bone marrow of subjects pre and during treatment.

Robert H. Lurie Cancer Center

Northwestern University

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Sodium Stibogluconate (SSG) 400 mg/m\^2 intravenous (IV) daily on days 1-5 + Interferon Alfa-2b (Intron A) 3x10\^6 units subcutaneously three times weekly

Sodium Stibogluconate

3x10\^6 units subcutaneously three times weekly

Interferon Alpha-2b

Aung Naing, MD

Primary Objective:

-To determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of SSG in combination with IFN alpha2b in patients with advanced malignancies.

Secondary Objectives:

* To correlate the AUC of SSG with clinical toxicity and efficacy.
* To quantify the effect of SSG on IFN alpha2b induced gene modulation and signal transduction pathways.
* To characterize the effects of SSG on PTPases SHP-1 and SHP-2.
* To assess the safety, efficacy, and PK of SSG in combination with IFN alpha2b.

Sodium stibogluconate is a drug that is able to block an enzyme in the cells that is responsible for cell growth. By blocking this enzyme, it may be able to prevent cancer cells from multiplying.

Interferon alfa-2b is a drug that activates an immune response to infections in the body. By triggering an immune response, this drug may help to prevent some cancer cells from growing and multiplying. You will receive treatment with both sodium stibogluconate and interferon alfa-2b, because sodium stibogluconate may improve the effectiveness of interferon in treating the cancer.

Participants will be enrolled in groups of 3 on this study, and the doses of the study drugs will be escalated for each group. This means that each new group of 3 participants will get a higher dose of the study drugs than the group before them. This will continue until the highest tolerable dose combination is found.

Once the highest tolerable dose has been found, up to an additional 9 participants, called the expansion group, will receive study drug at that dose. Your doctor will tell you if you are in the expansion group.

If you are found to be eligible to take part in this study, you will go to the clinic to start treatment. During Cycle 1, you will be given sodium stibogluconate once a day by vein during Days 1-5. On Days 8-12, you will be given sodium stibogluconate once a day by vein, and you will be given interferon alfa-2b for 3 days by injection just under the skin on Days 8, 10, and 12. For every cycle after Cycle 1, you will be given sodium stibogluconate once a day by vein during Days 1-5 and 8-12, and you will be given interferon alfa-2b for 3 days by injection just under the skin on Days 1, 3,5, 8, 10, and 12. Treatment cycles will last about 3 weeks (2 weeks on treatment, followed by 1 week off treatment).

During each visit to the clinic, you will be asked how you are feeling, and your vital signs will be measured. You will have a complete physical exam the first day of every cycle. On Days 1, 8, and 12 of every cycle, you will have a urine test to check the function of your kidneys, and blood (about 3 teaspoons) will be drawn for routine tests. On Days 1, 8, and 12 of every cycle and during your last study visit, you will have an additional blood draw (about 5 teaspoons) for immunological testing (to help researchers learn how your body fights disease) before treatment. On Days 1, 5, 8, and 12 of every cycle, you will have an ECG after you receive treatment.

At some time during the week before Day 1 of Cycle 1 and on Day 12 of Cycle 2, you may have a tumor biopsy to check the status of the disease before you receive the study drug. To perform a tumor biopsy, the affected area is numbed with anesthetic, and a small amount of tumor tissue is withdrawn through a large needle. Your doctor will tell you if this may be necessary.

On Days 1, 2, 9, 12, and 13 of Cycle 1, you will have blood drawn (about 1 teaspoon each) for PK testing. On Days 1, 8, and 12, the PK testing will be done before, 30 minutes after, and 2 hours after you receive the study drug. On Days 2 and 9, the PK testing will be done before treatment. On Day 13, the PK testing will be done 24 hours after you received treatment on Day 12.

After Cycle 1, you will be scheduled to return to the clinic in 10 days to receive treatment for Cycle 2, which will follow in the same manner as Cycle 1.

At the end of Cycle 2 and every even-numbered cycle (Cycles 4, 6, 8, and so on) after that, you will have imaging studies, such as x-rays and CT scans, to check the status of your tumors.

If the disease does not get worse and you do not experience any intolerable side effects after Cycle 1, you will continue on to Cycle 2, and so on. If at any time the disease gets worse or you experience any intolerable side effects, you will be taken off this study.

This is an investigational study. Sodium stibogluconate is not FDA approved or commercially available. It is authorized for use in research only. Interferon alfa-2b is approved by the FDA for the treatment of some types of cancers (solid tumors). The combination of these drugs is investigational in this study. Their use together is authorized for use in research only.

However, if sodium stibogluconate becomes commercially available while you are still on study. Up to 54 patients will take part in this multicenter study. Up to 35 will be enrolled at M. D. Anderson.

Sodium Stibogluconate With Interferon Alpha-2b for Patients With Advanced Malignancies

A Phase I, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Sodium Stibogluconate in Combination With Interferon Alpha-2b for Patients With Advanced Malignancies

MTD defined as the highest dose at which no dose limiting toxicity (DLT) occurs.

VioQuest Pharmaceuticals

M.D. Anderson Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Sodium Stibogluconate in the MDS/AML With One of the 65 Defined p53 Mutations	NCT04906031	Myelodysplastic... Acute Myeloid L... Myeloid Maligna... Temperature-Sen... Sodium Stiboglu... P53 Mutation	Sodium stiboglu...	18 Years - 75 Years	First Affiliated Hospital of Jinan University
Phase I/II Trial of Sodium Stibogluconate in Myelodysplastic Syndrome	NCT01009502	Myelodysplastic...	sodium stiboglu...	18 Years -	Northwestern University
Sodium Stibogluconate With Interferon Alpha-2b for Patients With Advanced Malignancies	NCT00629200	Advanced Cancer Solid Tumors	Sodium Stiboglu... Interferon Alph...	18 Years -	M.D. Anderson Cancer Center

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