Drugs / Dactinomycin
last change Jun 2026 re-read 8 days ago

Dactinomycin

also known as DACT · Actinomycin-D
Developed for
sarcoma · alveolar rhabdomyosarcoma · kidney cancer · rhabdomyosarcoma · childhood botryoid rhabdomyosarcoma · gestational trophoblastic neoplasm · kidney Wilms tumor · spindle cell rhabdomyosarcoma
+27 more · botryoid rhabdomyosarcoma · choriocarcinoma · hydatidiform mole · ovarian cancer · pleuropulmonary blastoma · rhabdoid tumor of the kidney · adult kidney Wilms tumor · adult malignant mesenchymoma · alveolar soft part sarcoma · central nervous system cancer · childhood kidney Wilms tumor · childhood malignant mesenchymoma · choroid plexus neoplasm · cutaneous melanoma · embryonal rhabdomyosarcoma · extragonadal germ cell tumor · invasive hydatidiform mole · leukemia · lymphoma · malignant testicular germ cell tumor · mixed cell type kidney Wilms' tumor · myxofibrosarcoma · undifferentiated pleomorphic sarcoma · urinary bladder cancer · urothelial carcinoma · uterine corpus choriocarcinoma · Ewing sarcoma
Investigated by
National Cancer Institute (NCI) · Children's Oncology Group · Children's Cancer and Leukaemia Group · Memorial Sloan Kettering Cancer Center · Societe Francaise Oncologie Pediatrique · University of Leicester
+24 more · German Society for Pediatric Oncology and Hematology GPOH gGmbH · Gynecologic Oncology Group · Japan Rhabdomyosarcoma Study Group · St. Jude Children's Research Hospital · Children's Hospitals and Clinics of Minnesota · Dana-Farber Cancer Institute · Ding Ma · Dutch Childhood Oncology Group · EBMT Solid Tumors Working Party · Eastern Cooperative Oncology Group · European Organisation for Research and Treatment of Cancer - EORTC · European Paediatric Soft Tissue Sarcoma Study Group · Fudan University · GOG Foundation · Gesellschaft fur Padiatrische Onkologie und Hamatologie - Austria · Huazhong University of Science and Technology · International Society of Pediatric Oncology · Italian Association for Pediatric Hematology Oncology · Queen Mary University of London · Shandong University · Swiss Cancer Institute · Tufts Medical Center · Zhejiang University · xiang yang

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) COSMEGEN — 2018-08-15 fda.gov ↗
Approved US (FDA) COSMEGEN — 1964-12-10 fda.gov ↗

Trials 43

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 217 trials
Phase 2 NCT07355855 Jan 2026 → Jan 2029 expected rhabdomyosarcoma Fudan University Not yet recruiting No outcome recorded
Phase 2 NCT06023641 Mar 2024 → Oct 2034 expected rhabdomyosarcoma St. Jude Children's Research Hospital Recruiting No outcome recorded
Phase 2 NCT04332874 Apr 2020 → Apr 2027 expected alveolar soft part sarcoma, myxofibrosarcoma, undifferentiated pleomorphic sarcoma Memorial Sloan Kettering Cancer Center Recruiting No outcome recorded
Phase 2 NCT02788201 Mar 2017 → Oct 2019 urinary bladder cancer, urothelial carcinoma National Cancer Institute (NCI) Completed No outcome recorded
Phase 2 NCT01871766 Dec 2013 → Dec 2026 expected rhabdomyosarcoma St. Jude Children's Research Hospital Active not recruiting No outcome recorded
Phase 2 NCT06309732 Jul 2006 → Jun 2013 malignant testicular germ cell tumor Queen Mary University of London Completed No outcome recorded
Phase 2 NCT00335556 Jun 2006 → Dec 2015 childhood kidney cell carcinoma, clear cell renal carcinoma, clear cell sarcoma of kidney, kidney Wilms tumor +2 Children's Oncology Group Completed Mixed
Phase 2 NCT00072280 Nov 2004 → Mar 2008 sarcoma Children's Oncology Group Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT00245089 May 2004 → Apr 2011 sarcoma Japan Rhabdomyosarcoma Study Group Unknown No outcome recorded
Phase 2 NCT00245141 May 2004 → Apr 2011 sarcoma Japan Rhabdomyosarcoma Study Group Unknown No outcome recorded
Phase 324 trials · 2 missed
Phase 3 NCT07466316 Jun 2026 → Mar 2031 expected rhabdomyosarcoma Children's Oncology Group Not yet recruiting No outcome recorded
Phase 3 NCT06401330 Apr 2025 → Feb 2031 expected mixed cell type kidney Wilms' tumor Children's Oncology Group Recruiting No outcome recorded
Phase 3 NCT06647953 Mar 2025 → Mar 2029 expected pleuropulmonary blastoma Children's Oncology Group Recruiting No outcome recorded
Phase 3 NCT05304585 Aug 2022 → Jun 2030 expected embryonal rhabdomyosarcoma, spindle cell rhabdomyosarcoma Children's Oncology Group Recruiting No outcome recorded
Phase 3 NCT04994132 Sep 2021 → Jun 2026 overdue alveolar rhabdomyosarcoma, botryoid rhabdomyosarcoma, spindle cell rhabdomyosarcoma Children's Oncology Group Active not recruiting No outcome recorded
Phase 3 NCT02567435 Jun 2016 → Jun 2023 overdue alveolar rhabdomyosarcoma, botryoid rhabdomyosarcoma, spindle cell rhabdomyosarcoma National Cancer Institute (NCI) Active not recruiting Missed primary
Phase 3 NCT01823315 Dec 2012 → Dec 2015 gestational trophoblastic neoplasm Ding Ma Unknown No outcome recorded
Phase 3 NCT01535053 Jun 2012 → May 2018 choriocarcinoma, gestational trophoblastic neoplasm, hydatidiform mole GOG Foundation Completed No outcome recorded
Phase 3 NCT01014767 Nov 2009 → Oct 2013 brain cancer, choroid plexus neoplasm Tufts Medical Center Terminated No outcome recorded
Phase 3 NCT00945009 Aug 2009 → Dec 2016 Beckwith-Wiedemann syndrome, adult kidney Wilms tumor, childhood kidney Wilms tumor, rhabdoid tumor of the kidney Children's Oncology Group Completed No outcome recorded
Phase not applicable2 trials
— NCT04562558 Sep 2020 → Nov 2024 overdue choriocarcinoma, invasive hydatidiform mole xiang yang Active not recruiting No outcome recorded
— NCT01464606 Dec 2009 → Dec 2025 overdue pleuropulmonary blastoma Children's Hospitals and Clinics of Minnesota Active not recruiting No outcome recorded
Comparator or background therapy8 trials
Phase 1/2 NCT01531244 Background Dec 2014 → Feb 2016 melanoma Washington University School of Medicine Withdrawn No outcome recorded
Phase 2 NCT06861244 Background Mar 2025 → Sep 2030 expected embryonal tumor with multilayered rosettes University of California, San Francisco Recruiting No outcome recorded
Phase 2 NCT01323517 Background Feb 2011 → Aug 2017 melanoma Memorial Sloan Kettering Cancer Center Completed No outcome recorded
Phase 2 NCT01055314 Background Jan 2010 → Jun 2016 alveolar rhabdomyosarcoma, embryonal rhabdomyosarcoma National Cancer Institute (NCI) Completed No outcome recorded
Phase 3 NCT02063022 Comparator Jan 2009 → Apr 2022 Ewing sarcoma Italian Sarcoma Group Completed No outcome recorded

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 51 sources stand behind the page.

FieldValueCited text
Known as dactinomycin “One or more of the following may be assigned by the physician (physician's choice) per standard of care guidelines upon study enrollment following surgery: Cytarabine,...” NCT06861244 ↗
50

“Induction treatment with: 4 cycle of Vincristine (9mg/,2), Dactinomycin (6mg/m2), Doxorubicin (160mg/m2), Cyclophosphamide (2.4g/m2), Ifosfamide (18g/M2) and Etoposide...” NCT02063022 ↗

“Regimen: dactinomycin d 0.6mg/m2, IV, on day1, 2; methotrexate 100mg/m2, IV, on day1 (after Act-d); methotrexate 200mg/m2, IVgtt, on day1 (after methotrexate, 500ml NS, \>4h).” NCT01823315 ↗

“Dactinomycin (A), intravenous infusion, 1.25mg/m2” NCT07355855 ↗

“Dacarbazine, Dactinomycin, Dasatinib” NCT02788201 ↗

NCT00003804 ↗

NCT00047138 ↗

NCT00002995 ↗

NCT00002766 ↗

NCT05304585 ↗

NCT00002610 ↗

Show 40 more sources

Known as Actinomycin-D “Pulse Actinomycin-D as Salvage Therapy for Failed Low Risk Gestational Trophoblastic Neoplasia” NCT00003688 ↗
Known as DACT “regimen EE-4A comprising dactinomycin (DACT) IV weekly on weeks 0, 3, 6, 9, 12, 15, and 18” NCT00002611 ↗
1

“Patients receive dactinomycin (DACT) IV on weeks 0, 3, 6, 9, 12, 15, and 18” NCT00002610 ↗

Route Intravenous “dactinomycin IV on days 1-3” NCT00002489 ↗