Phase I study of abagovomab in patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer Journal Article
| Authors: | 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, K.; Kepner, J.; Ferrone, S.; Odunsi, K. |
| Article Title: | Phase I study of abagovomab in patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer |
| 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. © 2006 American Association for Cancer Research. |
| Keywords: | adult; clinical article; controlled study; aged; middle aged; unclassified drug; clinical trial; drug tolerability; fatigue; dose response; drug safety; side effect; cancer staging; antineoplastic agent; ovarian neoplasms; t-lymphocytes; controlled clinical trial; ovary cancer; peritoneum cancer; cohort studies; peritoneal neoplasms; anemia; blood toxicity; leukopenia; randomized controlled trial; myalgia; enzyme linked immunosorbent assay; monoclonal antibody; abdominal pain; drug hypersensitivity; fever; injection site reaction; antibodies, monoclonal; immune response; gamma interferon; drug mechanism; laboratory test; multicenter study; vein thrombosis; immunogenicity; antibody response; cancer immunization; cytokine production; autoimmunity; injection site pain; headache; physical examination; phase 1 clinical trial; interferon-gamma; uterine tube carcinoma; intestine obstruction; ca-125 antigen; fallopian tube neoplasms; enzyme linked immunospot assay; histocompatibility antigens class ii; hla typing; drug dose regimen; absence of side effects; t lymphocyte activation; drug administration routes; antibody formation; antibody titer; abagovomab; interferon type ii; aca 125; antiidiotypic antibody |
| Journal Title: | Clinical Cancer Research |
| Volume: | 12 |
| Issue: | 18 |
| ISSN: | 1078-0432 |
| Publisher: | American Association for Cancer Research |
| Date Published: | 2006-09-15 |
| Start Page: | 5503 |
| End Page: | 5510 |
| Language: | English |
| DOI: | 10.1158/1078-0432.ccr-05-2670 |
| PUBMED: | 17000686 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | --- - "Cited By (since 1996): 29" - "Export Date: 4 June 2012" - "CODEN: CCREF" - "Source: Scopus" |
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