Clinical Trials

Numerous clinical trials evaluate Actinomycin D across Phase 1 through Phase 4 development in pediatric and adult oncology, focusing on Wilms tumor, gestational trophoblastic neoplasia, and soft tissue sarcomas such as rhabdomyosarcoma. Sponsored by cooperative networks, academic institutions, and government entities including the Children's Oncology Group, National Cancer Institute, and GOG Foundation, protocol statuses encompass recruiting, completed, unknown, and terminated studies. These include completed Phase 3 trials evaluating combination therapeutic regimens.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06023641 RECRUITING
Rhabdomyosarcoma
St. Jude Children's Research Hospital
 2024-03-13 PHASE2
NCT07466316 RECRUITING
Rhabdomyosarcoma
Children's Oncology Group
 2026-07-14 PHASE3
NCT06401330 RECRUITING
Stage I Mixed Cell Type Kidney Wilms Tumor; Stage II Mixed Cell Type Kidney Wilms Tumor; Stage III Mixed Cell Type Kidney Wilms Tumor; Stage IV Mixed Cell Type Kidney Wilms Tumor
Children's Oncology Group
 2025-04-15 PHASE3
NCT07194044 RECRUITING
Metastatic Ewing Sarcoma
H. Lee Moffitt Cancer Center and Research Institute
 2026-02-05 PHASE1
NCT05304585 RECRUITING
Embryonal Rhabdomyosarcoma; Fusion-Negative Alveolar Rhabdomyosarcoma; Spindle Cell/Sclerosing Rhabdomyosarcoma
Children's Oncology Group
 2022-08-04 PHASE3
NCT04625907 RECRUITING
Rhabdomyosarcoma
University of Birmingham
 2020-09-17 PHASE1; PHASE2
NCT06647953 RECRUITING
Pleuropulmonary Blastoma
Children's Oncology Group
 2025-03-21 PHASE3
NCT03669783 RECRUITING
Childhood Renal Tumor
Assistance Publique Hopitaux De Marseille
 2023-02-03 PHASE3
NCT04332874 RECRUITING
Sarcoma; Myxofibrosarcoma; Undifferentiated Pleomorphic Sarcoma; Alveolar Soft Part Sarcoma
Memorial Sloan Kettering Cancer Center
 2020-04-01 PHASE2
NCT01871766 ACTIVE_NOT_RECRUITING
Rhabdomyosarcoma
St. Jude Children's Research Hospital
 2013-12-04 PHASE2
NCT04388839 ACTIVE_NOT_RECRUITING
Rhabdomyosarcoma
H. Lee Moffitt Cancer Center and Research Institute
 2020-12-29 PHASE2
NCT04994132 ACTIVE_NOT_RECRUITING
Alveolar Rhabdomyosarcoma; Botryoid-Type Embryonal Rhabdomyosarcoma; Embryonal Rhabdomyosarcoma; Metastatic Embryonal Rhabdomyosarcoma; Metastatic Rhabdomyosarcoma; Solid Alveolar Rhabdomyosarcoma; Spindle Cell Rhabdomyosarcoma; Spindle Cell/Sclerosing Rhabdomyosarcoma
Children's Oncology Group
 2021-09-14 PHASE3
NCT01464606 ACTIVE_NOT_RECRUITING
Pleuropulmonary Blastoma
Children's Hospitals and Clinics of Minnesota
 2009-12-22
NCT06020755 RECRUITING
Gestational Trophoblastic Neoplasia
Peking Union Medical College Hospital
 2024-12 PHASE2
NCT06028672 RECRUITING
Gestational Trophoblastic Neoplasia
Peking Union Medical College Hospital
 2023-09-12
NCT04562558 ACTIVE_NOT_RECRUITING
Gestational Trophoblastic Tumor; Gestational Trophoblastic Neoplasia; Stage I Gestational Trophoblastic Tumor; Stage II Gestational Trophoblastic Tumor; Stage III Gestational Trophoblastic Tumor; Invasive Mole; Choriocarcinoma
xiang yang
 2020-09-29
NCT02639650 UNKNOWN
Gestational Trophoblastic Neoplasms
Weiguo Lv
 2016-03-01 PHASE3
NCT06252285 Recruiting
RSV Immunisation
Sanofi Pasteur a Sanofi Company|Sanofi
 2024-02-06 Phase 3
NCT05858723 Not yet recruiting
Allergic Contact Dermatitis
National Allergy Research Center Denmark
 2023-08 Not Applicable
NCT02567435 ACTIVE_NOT_RECRUITING
Alveolar Rhabdomyosarcoma; Botryoid-Type Embryonal Rhabdomyosarcoma; Embryonal Rhabdomyosarcoma; Rhabdomyosarcoma; Sclerosing Rhabdomyosarcoma; Spindle Cell Rhabdomyosarcoma
National Cancer Institute (NCI)
 2016-06-01 PHASE3
NCT03892330 NOT_YET_RECRUITING
0.5-14 Year Old Children With Nephroblastoma
Shengjing Hospital
 2019-06-01 PHASE4
NCT01535053 COMPLETED
Choriocarcinoma; FIGO Stage I Gestational Trophoblastic Tumor; FIGO Stage II Gestational Trophoblastic Tumor; FIGO Stage III Gestational Trophoblastic Tumor; Hydatidiform Mole
GOG Foundation
 2012-06-18 PHASE3
NCT01323517 COMPLETED
Melanoma
Memorial Sloan Kettering Cancer Center
 2011-02 PHASE2
NCT00945009 COMPLETED
Adult Kidney Wilms Tumor; Beckwith-Wiedemann Syndrome; Childhood Kidney Wilms Tumor; Diffuse Hyperplastic Perilobar Nephroblastomatosis; Rhabdoid Tumor of the Kidney; Stage I Kidney Wilms Tumor; Stage II Kidney Wilms Tumor; Stage III Kidney Wilms Tumor; Stage IV Kidney Wilms Tumor; Stage V Kidney Wilms Tumor
Children's Oncology Group
 2009-08-24 PHASE3
NCT00379340 COMPLETED
Stage III Kidney Wilms Tumor; Stage IV Kidney Wilms Tumor
Children's Oncology Group
 2007-04-30 PHASE3
NCT01055314 COMPLETED
Adult Rhabdomyosarcoma; Childhood Alveolar Rhabdomyosarcoma; Childhood Embryonal Rhabdomyosarcoma; Metastatic Childhood Soft Tissue Sarcoma; Stage IV Adult Soft Tissue Sarcoma; Untreated Childhood Rhabdomyosarcoma
National Cancer Institute (NCI)
 2010-01 PHASE2
NCT01531244 WITHDRAWN
Melanoma
Washington University School of Medicine
 2014-12 PHASE1; PHASE2
NCT01823315 UNKNOWN
Gestational Trophoblastic Disease; Gestational Trophoblastic Neoplasia; Gestational Trophoblastic Tumor; Gestational Trophoblastic Neoplasms
Ding Ma
 2012-12 PHASE3
NCT00335556 COMPLETED
Childhood Renal Cell Carcinoma; Clear Cell Renal Cell Carcinoma; Clear Cell Sarcoma of the Kidney; Papillary Renal Cell Carcinoma; Rhabdoid Tumor of the Kidney; Stage I Renal Cell Cancer; Stage I Renal Wilms Tumor; Stage II Renal Cell Cancer; Stage II Renal Wilms Tumor; Stage III Renal Cell Cancer; Stage III Renal Wilms Tumor; Stage IV Renal Cell Cancer; Stage IV Renal Wilms Tumor
Children's Oncology Group
 2006-06 PHASE2
NCT00354835 COMPLETED
Adult Rhabdomyosarcoma; Childhood Alveolar Rhabdomyosarcoma; Childhood Botryoid-Type Embryonal Rhabdomyosarcoma; Childhood Embryonal Rhabdomyosarcoma; Localized Childhood Soft Tissue Sarcoma; Rhabdomyosarcoma; Sarcoma; Stage I Adult Soft Tissue Sarcoma AJCC v7; Stage II Adult Soft Tissue Sarcoma AJCC v7; Stage III Adult Soft Tissue Sarcoma AJCC v7
Children's Oncology Group
 2006-12-26 PHASE3
NCT00352534 COMPLETED
Stage I Kidney Wilms Tumor; Stage II Kidney Wilms Tumor; Stage III Kidney Wilms Tumor
Children's Oncology Group
 2006-11-06 PHASE3
NCT01014767 TERMINATED
Brain Cancer; Choroid Plexus Tumors
Tufts Medical Center
 2009-11 PHASE3
NCT00541411 UNKNOWN
Ewing's Sarcoma
King Faisal Specialist Hospital & Research Center
 2003-06
NCT06309732 COMPLETED
Testicular Neoplasms
Queen Mary University of London
 2006-07 PHASE2
NCT00075582 COMPLETED
Adult Rhabdomyosarcoma; Embryonal Childhood Rhabdomyosarcoma; Embryonal-botryoid Childhood Rhabdomyosarcoma; Previously Untreated Childhood Rhabdomyosarcoma
Children's Oncology Group
 2004-09-04 PHASE3
NCT00020566 UNKNOWN
Sarcoma
University of Leicester
 2001-02 PHASE3
NCT00002766 COMPLETED
Leukemia; Lymphoma
Memorial Sloan Kettering Cancer Center
 1996-03 PHASE3
NCT00379457 UNKNOWN
Sarcoma
European Paediatric Soft Tissue Sarcoma Study Group
 2006-06 PHASE3
NCT00245089 UNKNOWN
Sarcoma
Japan Rhabdomyosarcoma Study Group
 2004-05 PHASE2
NCT00245141 UNKNOWN
Sarcoma
Japan Rhabdomyosarcoma Study Group
 2004-05 PHASE2
NCT00003702 COMPLETED
Good Prognosis Metastatic Gestational Trophoblastic Tumor; Hydatidiform Mole; Non-Metastatic Gestational Trophoblastic Tumor; Uterine Corpus Choriocarcinoma
Gynecologic Oncology Group
 1999-06 PHASE3
NCT00354744 COMPLETED
Sarcoma
Children's Oncology Group
 2006-07 PHASE3
NCT00025103 UNKNOWN
Kidney Cancer
Children's Cancer and Leukaemia Group
 2001-05 PHASE2
NCT00072280 TERMINATED
Sarcoma
Children's Oncology Group
 2004-11 PHASE2
NCT00084838 COMPLETED
Central Nervous System Tumor, Pediatric
Dana-Farber Cancer Institute
 2003-02 PHASE2
NCT00003958 COMPLETED
Adult Malignant Mesenchymoma; Adult Rhabdomyosarcoma; Alveolar Childhood Rhabdomyosarcoma; Childhood Malignant Mesenchymoma; Embryonal Childhood Rhabdomyosarcoma; Embryonal-botryoid Childhood Rhabdomyosarcoma; Nonmetastatic Childhood Soft Tissue Sarcoma; Previously Untreated Childhood Rhabdomyosarcoma; Stage I Adult Soft Tissue Sarcoma; Stage II Adult Soft Tissue Sarcoma; Stage III Adult Soft Tissue Sarcoma
Children's Oncology Group
 2002-09 PHASE3
NCT00004250 COMPLETED
Melanoma (Skin); Sarcoma
Memorial Sloan Kettering Cancer Center
 1999-08 PHASE2
NCT00002995 COMPLETED
Sarcoma
Children's Oncology Group
 1997-08 PHASE3
NCT00003688 COMPLETED
Gestational Trophoblastic Tumor
Gynecologic Oncology Group
 1999-10 PHASE2
NCT00003955 COMPLETED
Sarcoma
Children's Oncology Group
 1999-09 PHASE2
NCT00002610 COMPLETED
Kidney Cancer
Children's Oncology Group
 1996-01 PHASE3
NCT00002611 COMPLETED
Kidney Cancer
Children's Oncology Group
 1995-07 PHASE3
NCT00002489 COMPLETED
Extragonadal Germ Cell Tumor; Ovarian Cancer
Memorial Sloan Kettering Cancer Center
 1991-10 PHASE2
NCT00491946 UNKNOWN
Cancer
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
 2004-06 PHASE4
NCT00025441 COMPLETED
Ovarian Cancer; Sarcoma; Small Intestine Cancer
Societe Internationale d'Oncologie Pediatrique
 1998-11 PHASE2
NCT00002898 COMPLETED
Childhood Malignant Fibrous Histiocytoma of Bone; Sarcoma
Societe Internationale d'Oncologie Pediatrique
 1995-01 PHASE3
NCT00002516 UNKNOWN
Sarcoma
University Hospital Muenster
 1992-07 PHASE3
NCT00003804 UNKNOWN
Kidney Cancer
University of Leicester
 1993-07 PHASE3
NCT00047138 UNKNOWN
Kidney Cancer
University of Leicester
 2001-01 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-06-15)

Check the Actinomycin D (Dactinomycin) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Actinomycin D intercalates into duplex DNA and binds adjacent guanine-cytosine base pairs, thereby transcriptionally blocking RNA polymerase elongation and impairing protein synthesis to induce G1-phase cell cycle arrest and cell death. This targeted inhibition of macromolecular synthesis and suppression of cellular repair directly underpins its clinical utility in suppressing tumor growth across malignancies such as rhabdomyosarcoma, Wilms tumor, and gestational trophoblastic neoplasia.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.