Phase I study of abagovomab in patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer

Paul Sabbatini, Jakob Dupont, Carol Aghajanian, Felicia Derosa, Elizabeth Poynor, Sybil Anderson, Martee Hensley, Phillip Livingston, Alexia Iasonos, David Spriggs, William McGuire, Silke Reinartz, Sally Schneider, Cathy Grande, Shashikant Lele, Kerry J Rodabaugh, James Kepner, Soldano Ferrone, Kunle Odunsi

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Abstract

Purpose: This open-label study assessed the safety and immunogenicity of two doses and two routes of the anti-idiotypic monoclonal antibody abagovomab (formerly ACA125) in patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer. Experimental Design: Eligible patients from the three participating institutions were any stage at diagnosis, had relapsed, and had complete or partial response to additional chemotherapy. Patients were randomized to receive abagovomab at 2.0 versus 0.2 mg and i.m. versus s.c. for four immunizations every 2 weeks and then monthly for two additional immunizations. Planned evaluation included interval physical examinations and laboratory assessments with immune assessment, including HLA typing, human anti-mouse antibody, ELISA, and enzyme-linked immunospot. Patients were required to remain on study until week 10 (the first post-baseline Ab3 determination) to be considered for immunologic assessment. The primary end points were safety and immunogenicity primarily determined by Ab3 response. Results: Forty-two patients received at least one vaccination and were eligible for safety analysis. Thirty-three patients were available for Ab3 analysis (removed for progression of disease, 6; withdrawal of consent, 2; unrelated adverse event, 1). The most common adverse events were self-limited pain at injection site, myalgia, and fever. No hematologic or nonhematologic toxicity grade >2 related to immunization was seen. Ab3 was detectable in all patients (median, 236,794 ng/mL); none of route of administration (P = 0.6268), dose (P = 0.4602), or cohort (P = 0.4944) was statistically significant in terms of effect on maximum post-baseline Ab3 titer. Human anti-mouse antibody was not detectable at baseline but was present in all patients at week 16 (range, 488-45,000 ng/mL). Conclusions: Immunization with abagovomab is well tolerated and induced robust Ab3 responses at the two doses and routes tested. A phase III randomized study with abagovomab (2.0 mg s.c.) is warranted.

Original languageEnglish (US)
Pages (from-to)5503-5510
Number of pages8
JournalClinical Cancer Research
Volume12
Issue number18
DOIs
StatePublished - Sep 15 2006

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Fallopian Tubes
Immunization
Neoplasms
Anti-Idiotypic Antibodies
Safety
Histocompatibility Testing
abagovomab
Myalgia
Physical Examination
Disease Progression
Vaccination
Research Design
Fever
Enzyme-Linked Immunosorbent Assay
Monoclonal Antibodies
Drug Therapy
Pain
Injections
Enzymes

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Sabbatini, P., Dupont, J., Aghajanian, C., Derosa, F., Poynor, E., Anderson, S., ... Odunsi, K. (2006). Phase I study of abagovomab in patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer. Clinical Cancer Research, 12(18), 5503-5510. https://doi.org/10.1158/1078-0432.CCR-05-2670

Phase I study of abagovomab in patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer. / Sabbatini, Paul; Dupont, Jakob; Aghajanian, Carol; Derosa, Felicia; Poynor, Elizabeth; Anderson, Sybil; Hensley, Martee; Livingston, Phillip; Iasonos, Alexia; Spriggs, David; McGuire, William; Reinartz, Silke; Schneider, Sally; Grande, Cathy; Lele, Shashikant; Rodabaugh, Kerry J; Kepner, James; Ferrone, Soldano; Odunsi, Kunle.

In: Clinical Cancer Research, Vol. 12, No. 18, 15.09.2006, p. 5503-5510.

Research output: Contribution to journalArticle

Sabbatini, P, Dupont, J, Aghajanian, C, Derosa, F, Poynor, E, Anderson, S, Hensley, M, Livingston, P, Iasonos, A, Spriggs, D, McGuire, W, Reinartz, S, Schneider, S, Grande, C, Lele, S, Rodabaugh, KJ, Kepner, J, Ferrone, S & Odunsi, K 2006, 'Phase I study of abagovomab in patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer', Clinical Cancer Research, vol. 12, no. 18, pp. 5503-5510. https://doi.org/10.1158/1078-0432.CCR-05-2670
Sabbatini, Paul ; Dupont, Jakob ; Aghajanian, Carol ; Derosa, Felicia ; Poynor, Elizabeth ; Anderson, Sybil ; Hensley, Martee ; Livingston, Phillip ; Iasonos, Alexia ; Spriggs, David ; McGuire, William ; Reinartz, Silke ; Schneider, Sally ; Grande, Cathy ; Lele, Shashikant ; Rodabaugh, Kerry J ; Kepner, James ; Ferrone, Soldano ; Odunsi, Kunle. / Phase I study of abagovomab in patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer. In: Clinical Cancer Research. 2006 ; Vol. 12, No. 18. pp. 5503-5510.
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AU - Sabbatini, Paul

AU - Dupont, Jakob

AU - Aghajanian, Carol

AU - Derosa, Felicia

AU - Poynor, Elizabeth

AU - Anderson, Sybil

AU - Hensley, Martee

AU - Livingston, Phillip

AU - Iasonos, Alexia

AU - Spriggs, David

AU - McGuire, William

AU - Reinartz, Silke

AU - Schneider, Sally

AU - Grande, Cathy

AU - Lele, Shashikant

AU - Rodabaugh, Kerry J

AU - Kepner, James

AU - Ferrone, Soldano

AU - Odunsi, Kunle

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N2 - Purpose: This open-label study assessed the safety and immunogenicity of two doses and two routes of the anti-idiotypic monoclonal antibody abagovomab (formerly ACA125) in patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer. Experimental Design: Eligible patients from the three participating institutions were any stage at diagnosis, had relapsed, and had complete or partial response to additional chemotherapy. Patients were randomized to receive abagovomab at 2.0 versus 0.2 mg and i.m. versus s.c. for four immunizations every 2 weeks and then monthly for two additional immunizations. Planned evaluation included interval physical examinations and laboratory assessments with immune assessment, including HLA typing, human anti-mouse antibody, ELISA, and enzyme-linked immunospot. Patients were required to remain on study until week 10 (the first post-baseline Ab3 determination) to be considered for immunologic assessment. The primary end points were safety and immunogenicity primarily determined by Ab3 response. Results: Forty-two patients received at least one vaccination and were eligible for safety analysis. Thirty-three patients were available for Ab3 analysis (removed for progression of disease, 6; withdrawal of consent, 2; unrelated adverse event, 1). The most common adverse events were self-limited pain at injection site, myalgia, and fever. No hematologic or nonhematologic toxicity grade >2 related to immunization was seen. Ab3 was detectable in all patients (median, 236,794 ng/mL); none of route of administration (P = 0.6268), dose (P = 0.4602), or cohort (P = 0.4944) was statistically significant in terms of effect on maximum post-baseline Ab3 titer. Human anti-mouse antibody was not detectable at baseline but was present in all patients at week 16 (range, 488-45,000 ng/mL). Conclusions: Immunization with abagovomab is well tolerated and induced robust Ab3 responses at the two doses and routes tested. A phase III randomized study with abagovomab (2.0 mg s.c.) is warranted.

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