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Phase 1b Study of IGF-Methotrexate Conjugate in the Treatment of High-grade Myelodysplastic Syndromes.
Anticancer Res. 2020 Jul; 40(7):3883-3888.AR

Abstract

BACKGROUND/AIM

The insulin-like growth factor type 1 receptor (IGF-1R) is overexpressed in myelodysplastic syndrome (MDS) cells, and 765IGF-Methotrexate (IGF-MTX) is a conjugate of methotrexate and a variant of insulin-like growth factor-1 (IGF-1) designed to selectively target cancer cells through binding to IGF-1R. The aim of this study was to determine whether IGF-MTX would be effective to treat MDS.

PATIENTS AND METHODS

In this phase I clinical trial, two patients with high grade MDS or oligoblastic acute myeloid leukemia (O-AML) that had failed standard therapy were treated with IGF-MTX.

RESULTS

No dose-limiting toxicity was observed. Both patients had stable or improved cell counts and CD34+ myelodysplastic cell counts and exceeded their life expectancy (both alive at 1.9 years despite a life expectancy of less than 6 months). Bone marrow blast counts decreased from 22% to 5% in one patient, and from 17% to 16% in the other.

CONCLUSION

In conclusion, IGF-MTX at 0.20 μM equivalents per kg was well tolerated, caused no cytopenia, and produced stable disease and extension of life.

Authors+Show Affiliations

Department of Medicine, Division of Hematology and Oncology, Mayo Clinic, Rochester, MN, U.S.A.Department of Medicine, Division of Hematology and Oncology, Mayo Clinic, Rochester, MN, U.S.A.Department of Medicine, Division of Hematology and Oncology, Mayo Clinic, Rochester, MN, U.S.A.Department of Medicine, Division of Hematology and Oncology, Mayo Clinic, Rochester, MN, U.S.A.Department of Medicine, Division of Hematology and Oncology, Mayo Clinic, Rochester, MN, U.S.A.IGF Oncology, LLC, Saint Paul, MN, U.S.A. hmctavish@igfoncology.com.IGF Oncology, LLC, Saint Paul, MN, U.S.A. Regions Cancer Care Center, HealthPartners Institute, Minneapolis, MN, U.S.A.

Pub Type(s)

Case Reports
Clinical Trial, Phase I
Journal Article

Language

eng

PubMed ID

32620628

Citation

Alkhateeb, Hassan B., et al. "Phase 1b Study of IGF-Methotrexate Conjugate in the Treatment of High-grade Myelodysplastic Syndromes." Anticancer Research, vol. 40, no. 7, 2020, pp. 3883-3888.
Alkhateeb HB, Patnaik MM, Al-Kali A, et al. Phase 1b Study of IGF-Methotrexate Conjugate in the Treatment of High-grade Myelodysplastic Syndromes. Anticancer Res. 2020;40(7):3883-3888.
Alkhateeb, H. B., Patnaik, M. M., Al-Kali, A., Zblewski, D. L., Wallerich, S., McTavish, H., & Dudek, A. Z. (2020). Phase 1b Study of IGF-Methotrexate Conjugate in the Treatment of High-grade Myelodysplastic Syndromes. Anticancer Research, 40(7), 3883-3888. https://doi.org/10.21873/anticanres.14378
Alkhateeb HB, et al. Phase 1b Study of IGF-Methotrexate Conjugate in the Treatment of High-grade Myelodysplastic Syndromes. Anticancer Res. 2020;40(7):3883-3888. PubMed PMID: 32620628.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Phase 1b Study of IGF-Methotrexate Conjugate in the Treatment of High-grade Myelodysplastic Syndromes. AU - Alkhateeb,Hassan B, AU - Patnaik,Mrinal M, AU - Al-Kali,Aref, AU - Zblewski,Darci L, AU - Wallerich,Samantha, AU - McTavish,Hugh, AU - Dudek,Arkadiusz Z, PY - 2020/05/29/received PY - 2020/06/19/revised PY - 2020/06/20/accepted PY - 2020/7/5/entrez PY - 2020/7/6/pubmed PY - 2020/8/6/medline KW - IGF-1R KW - IGF-MTX KW - chronic myelomonocytic leukemia KW - myelodysplastic syndrome KW - oligoblastic acute myeloid leukemia KW - phase 1 study SP - 3883 EP - 3888 JF - Anticancer research JO - Anticancer Res. VL - 40 IS - 7 N2 - BACKGROUND/AIM: The insulin-like growth factor type 1 receptor (IGF-1R) is overexpressed in myelodysplastic syndrome (MDS) cells, and 765IGF-Methotrexate (IGF-MTX) is a conjugate of methotrexate and a variant of insulin-like growth factor-1 (IGF-1) designed to selectively target cancer cells through binding to IGF-1R. The aim of this study was to determine whether IGF-MTX would be effective to treat MDS. PATIENTS AND METHODS: In this phase I clinical trial, two patients with high grade MDS or oligoblastic acute myeloid leukemia (O-AML) that had failed standard therapy were treated with IGF-MTX. RESULTS: No dose-limiting toxicity was observed. Both patients had stable or improved cell counts and CD34+ myelodysplastic cell counts and exceeded their life expectancy (both alive at 1.9 years despite a life expectancy of less than 6 months). Bone marrow blast counts decreased from 22% to 5% in one patient, and from 17% to 16% in the other. CONCLUSION: In conclusion, IGF-MTX at 0.20 μM equivalents per kg was well tolerated, caused no cytopenia, and produced stable disease and extension of life. SN - 1791-7530 UR - https://www.unboundmedicine.com/medline/citation/32620628/Phase_1b_Study_of_IGF-Methotrexate_Conjugate_in_the_Treatment_of_High-grade_Myelodysplastic_Syndromes L2 - http://ar.iiarjournals.org/cgi/pmidlookup?view=long&pmid=32620628 DB - PRIME DP - Unbound Medicine ER -