Clinical Trials

Dacarbazine has been evaluated in numerous Phase 1 through Phase 4 clinical trials, assessing its efficacy as a monotherapy or in combination regimens for malignancies including cutaneous and metastatic melanoma, Hodgkin lymphoma, leiomyosarcoma, and advanced soft tissue sarcomas. Sponsored by various industry partners and academic institutions, these studies encompass completed, recruiting, active not recruiting, and terminated statuses. Specific Phase 1 and Phase 3 protocols focus on optimizing treatments for advanced liposarcomas and melanoma.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06745076 RECRUITING
Advanced Hodgkin Lymphoma; Classic Hodgkin Lymphoma; Lugano Classification Stage III Hodgkin Lymphoma AJCC v8; Lugano Classification Stage IV Hodgkin Lymphoma AJCC v8
University of Washington
2025-03-06 PHASE2
NCT05675410 RECRUITING
Lugano Classification Limited Stage Hodgkin Lymphoma AJCC v8
National Cancer Institute (NCI)
2023-05-11 PHASE3
NCT07551583 RECRUITING
Hodgkin Lymphoma
M.D. Anderson Cancer Center
2026-08-19 PHASE2
NCT04685616 RECRUITING
Hodgkin Lymphoma
University College, London
2022-04-14 PHASE3
NCT07002216 RECRUITING
Hodgkin Lymphoma; Advanced Hodgkin Lymphoma
University of Miami
2025-07-15 PHASE2
NCT06563245 RECRUITING
Classical Hodgkin Lymphoma; Child; Adolescent; Young Adult; Metabolic Response; Survival; Treatment; Brentuximab Vedotin; PET Scan
Children's Cancer Group, China
2024-09-25 PHASE2; PHASE3
NCT07275216 RECRUITING
Classic Hodgkin Lymphoma
City of Hope Medical Center
2026-10-01 PHASE2
NCT07400302 RECRUITING
Mucosal Melanoma; PD-L1 Positive
The First Hospital of Jilin University
2026-04-10 PHASE2
NCT06624644 RECRUITING
Melanoma (Skin Cancer); Melanoma Stage IIIB-IV; Cutaneous Melanoma; Unresectable Melanoma
Linnaeus Therapeutics, Inc.
2025-08-06 PHASE2; PHASE3
NCT04535271 RECRUITING
Leiomyosarcoma
Sarcoma Oncology Research Center, LLC
2021-09-09 PHASE2
NCT06346067 ACTIVE_NOT_RECRUITING
Advanced or Metastatic NRAS-mutant Melanoma
Erasca, Inc.
2024-04-29 PHASE3
NCT06831370 RECRUITING
Hodgkin Lymphoma
Takeda
2024-08-28 PHASE4
NCT06835049 RECRUITING
Sarcoma,Soft Tissue
Swiss Cancer Institute
2025-10-27 PHASE2
NCT06984146 RECRUITING
Hodgkin Lymphoma, Adult
National Medical Research Radiological Centre of the Ministry of Health of Russia
2025-04-15 PHASE2
NCT07310784 RECRUITING
Advanced Melanoma
Suzhou BlueHorse Therapeutics Co., Ltd.
2025-12-16 PHASE2
NCT03016819 RECRUITING
Alveolar Soft Part Sarcoma; Leiomyosarcoma; Synovial Sarcoma; Soft-Tissue Sarcoma
Advenchen Laboratories, LLC
2017-08-15 PHASE3
NCT05922904 ACTIVE_NOT_RECRUITING
Hodgkin Lymphoma
M.D. Anderson Cancer Center
2023-12-14 PHASE2
NCT05404945 ACTIVE_NOT_RECRUITING
Classical Hodgkin Lymphoma
University of Virginia
2022-07-26 PHASE2
NCT06008106 RECRUITING
Melanoma
Shanghai Kechow Pharma, Inc.
2023-11-02 PHASE3
NCT06377566 RECRUITING
Hodgkin Lymphoma
Memorial Sloan Kettering Cancer Center
2024-04-17 PHASE2
NCT03033914 ACTIVE_NOT_RECRUITING
Hodgkin Lymphoma
Memorial Sloan Kettering Cancer Center
2017-01-25 PHASE1; PHASE2
NCT04638790 RECRUITING
Hodgkin Lymphoma, Adult
State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
2020-02-01 PHASE3
NCT03805022 RECRUITING
Non-metastatic Soft-tissue Sarcoma; Resectable
Institut Bergonié
2019-02-14 PHASE3
NCT03407144 ACTIVE_NOT_RECRUITING
Hodgkin Lymphoma
Merck Sharp & Dohme LLC
2018-04-09 PHASE2
NCT06703398 RECRUITING
Melanoma
Shanghai Juncell Therapeutics
2024-12-20 PHASE2
NCT04067037 ACTIVE_NOT_RECRUITING
Classical Hodgkin Lymphoma
Henan Cancer Hospital
2019-08-26 PHASE2
NCT04727242 COMPLETED
LMS - Leiomyosarcoma; Uterine Leiomyosarcoma
Stanford University
2021-01-28 PHASE2
NCT04225390 COMPLETED
Immunotherapy
University of Erlangen-Nürnberg Medical School
2020-01-13 PHASE2
NCT02994498 UNKNOWN
Advanced Melanoma
Chung Mei Biopharma Co., Ltd
2023-03 PHASE1; PHASE2
NCT06164275 ACTIVE_NOT_RECRUITING
Classic Hodgkin Lymphoma
Northwestern University
2024-02-06 PHASE2
NCT03233347 ACTIVE_NOT_RECRUITING
Ann Arbor Stage I Hodgkin Lymphoma; Ann Arbor Stage IA Hodgkin Lymphoma; Ann Arbor Stage IB Hodgkin Lymphoma; Ann Arbor Stage II Hodgkin Lymphoma; Ann Arbor Stage IIA Hodgkin Lymphoma; Ann Arbor Stage IIB Hodgkin Lymphoma; Classic Hodgkin Lymphoma
Academic and Community Cancer Research United
2017-10-13 PHASE2
NCT05900765 UNKNOWN
Classical Hodgkin Lymphoma
Sun Yat-sen University
2023-06-14 PHASE2
NCT07171827 COMPLETED
Anti-CD30; Brentuximab; Doxorubicin; Vinblastine; Dacarbazine; Frontline; Advanced Classical Hodgkin Lymphoma
Helwan University
2023-03-01
NCT06201507 UNKNOWN
Hodgkin Lymphoma
Beijing Children's Hospital
2022-10-01 PHASE2
NCT03712202 ACTIVE_NOT_RECRUITING
Ann Arbor Stage I Hodgkin Lymphoma; Ann Arbor Stage I Mixed Cellularity Classic Hodgkin Lymphoma; Ann Arbor Stage I Nodular Sclerosis Classic Hodgkin Lymphoma; Ann Arbor Stage IA Hodgkin Lymphoma; Ann Arbor Stage IB Hodgkin Lymphoma; Ann Arbor Stage II Hodgkin Lymphoma; Ann Arbor Stage IIA Hodgkin Lymphoma; Ann Arbor Stage IIB Hodgkin Lymphoma; Classic Hodgkin Lymphoma; Lymphocyte-Rich Classic Hodgkin Lymphoma; Ann Arbor Stage I Lymphocyte-Depleted Classic HL; Ann Arbor Stage II Lymphocyte-Depleted Classic HL; Ann Arbor Stage II Mixed Cellularity Classic HL; Ann Arbor Stage II Nodular Sclerosis Classic HL
City of Hope Medical Center
2018-11-28 PHASE2
NCT03023124 COMPLETED
Solitary Fibrous Tumors
Italian Sarcoma Group
2018-03-04 PHASE2
NCT02684708 COMPLETED
Classical Hodgkin Lymphoma
University of Giessen
2015-10-01 PHASE3
NCT03277924 COMPLETED
Soft Tissue Sarcoma; Bone Sarcoma
Grupo Espanol de Investigacion en Sarcomas
2017-05-31 PHASE1; PHASE2
NCT01710176 COMPLETED
Localized High-risk Soft Tissue Sarcomas of the Extremities and Trunk Wall in Adults
Italian Sarcoma Group
2011-06-01 PHASE3
NCT05466474 UNKNOWN
Advanced Melanoma
Henan Cancer Hospital
2022-12-30 PHASE2
NCT03761095 COMPLETED
Leiomyosarcoma
PTC Therapeutics
2019-03-13 PHASE1
NCT03331341 COMPLETED
Classical Hodgkin Lymphoma
University of Washington
2019-01-09 PHASE1; PHASE2
NCT05008224 COMPLETED
Classical Hodgkin Lymphoma
Merck Sharp & Dohme LLC
2021-10-07 PHASE2
NCT03517137 ACTIVE_NOT_RECRUITING
Advanced Hodgkin Lymphoma
European Organisation for Research and Treatment of Cancer - EORTC
2019-08-01 PHASE2
NCT03430297 COMPLETED
Metastatic Melanoma; Unresectable Melanoma
Shanghai Junshi Bioscience Co., Ltd.
2018-02-02 PHASE3
NCT04843267 UNKNOWN
Hodgkin Lymphoma; Chemotherapy Effect
Sun Yat-sen University
2021-05-01 PHASE2
NCT01716806 COMPLETED
Hodgkin Disease; Peripheral T Cell Lymphoma
Seagen Inc.
2012-10-31 PHASE2
NCT04200040 UNKNOWN
Melanoma (Skin)
OrienGene Biotechnology Ltd.
2017-08-27 PHASE2
NCT02661503 UNKNOWN
Classical Hodgkin Lymphoma
University of Cologne
2016-07 PHASE3
NCT02797717 RECRUITING
Classical Hodgkins Lymphoma in Children and Adolescents.
GALIA AVRAHAMI
2015-11
NCT03646123 TERMINATED
Hodgkin Lymphoma
Seagen Inc.
2019-01-28 PHASE2
NCT03004833 COMPLETED
Classical Hodgkin Lymphoma
University of Cologne
2017-02-21 PHASE2
NCT02501551 UNKNOWN
Melanoma
Yonsei University
2015-02 PHASE2
NCT03159897 COMPLETED
Hodgkin Lymphoma
Fondazione Italiana Linfomi - ETS
2017-08-01 PHASE3
NCT01771107 COMPLETED
AIDS-Related Hodgkin Lymphoma; Ann Arbor Stage II Hodgkin Lymphoma; Ann Arbor Stage IIA Hodgkin Lymphoma; Ann Arbor Stage IIB Hodgkin Lymphoma; Ann Arbor Stage III Hodgkin Lymphoma; Ann Arbor Stage IIIA Hodgkin Lymphoma; Ann Arbor Stage IIIB Hodgkin Lymphoma; Ann Arbor Stage IV Hodgkin Lymphoma; Ann Arbor Stage IVA Hodgkin Lymphoma; Ann Arbor Stage IVB Hodgkin Lymphoma; Classic Hodgkin Lymphoma; HIV Infection
National Cancer Institute (NCI)
2013-03-08 PHASE1; PHASE2
NCT03527628 UNKNOWN
Classical Hodgkin Lymphoma; Hodgkin Lymphoma (Category); Hodgkin Disease; Hodgkin Lymphoma
King Abdullah International Medical Research Center
2018-01-01 PHASE2
NCT01920932 ACTIVE_NOT_RECRUITING
Stage II Childhood Hodgkin Lymphoma; Stage III Childhood Hodgkin Lymphoma; Stage IV Childhood Hodgkin Lymphoma
St. Jude Children's Research Hospital
2013-08-12 PHASE2
NCT03342300 WITHDRAWN
Progression-free Survival; Overall Survival; Toxicity
Peking University People's Hospital
2017-11-06 PHASE2; PHASE3
NCT03070392 COMPLETED
Uveal Melanoma
Immunocore Ltd
2017-10-16 PHASE2
NCT02979522 ACTIVE_NOT_RECRUITING
Hodgkin Disease
Takeda
2017-09-06 PHASE1; PHASE2
NCT01356680 COMPLETED
Hodgkin Lymphoma
University of Cologne
2012-01-13 PHASE3
NCT03279601 UNKNOWN
Neuroendocrine Tumors
Peking University
2017-09-01 PHASE2
NCT02758717 ACTIVE_NOT_RECRUITING
Ann Arbor Stage IB Hodgkin Lymphoma; Ann Arbor Stage II Hodgkin Lymphoma; Ann Arbor Stage IIA Hodgkin Lymphoma; Ann Arbor Stage IIB Hodgkin Lymphoma; Ann Arbor Stage III Hodgkin Lymphoma; Ann Arbor Stage IIIA Hodgkin Lymphoma; Ann Arbor Stage IIIB Hodgkin Lymphoma; Ann Arbor Stage IV Hodgkin Lymphoma; Ann Arbor Stage IVA Hodgkin Lymphoma; Ann Arbor Stage IVB Hodgkin Lymphoma; Classic Hodgkin Lymphoma
Academic and Community Cancer Research United
2016-05-13 PHASE2
NCT01280565 TERMINATED
Metastatic Melanoma
AB Science
2011-01 PHASE3
NCT02505269 COMPLETED
Hodgkin Lymphoma
Massachusetts General Hospital
2015-08-07 PHASE2
NCT03226249 UNKNOWN
Classical Hodgkin Lymphoma; Lymphocyte-Depleted Classical Hodgkin Lymphoma; Lymphocyte-Rich Classical Hodgkin Lymphoma; Mixed Cellularity Classical Hodgkin Lymphoma; Nodular Sclerosis Classical Hodgkin Lymphoma
Northwestern University
2017-11-09 PHASE2
NCT02545075 COMPLETED
Melanoma
Bristol-Myers Squibb
2015-10-31 PHASE3
NCT03761095 Completed
Leiomyosarcoma
PTC Therapeutics
2019-03-13 Phase 1
NCT00654732 COMPLETED
Classic Hodgkin Lymphoma; Lugano Classification Stage III Hodgkin Lymphoma AJCC v8; Lugano Classification Stage IV Hodgkin Lymphoma AJCC v8
M.D. Anderson Cancer Center
2008-03-19 PHASE2
NCT00736320 UNKNOWN
Hodgkin Lymphoma
University of Cologne
2009-11 PHASE3
NCT03095079 UNKNOWN
Melanoma
Peking University Cancer Hospital & Institute
2016-10 PHASE2
NCT07671495 COMPLETED
Melanoma Stage I; Melanoma Stage III; Melanoma Stage II; Skin Melanoma
MIPO Clinic
2014-01 PHASE2
NCT01551459 COMPLETED
Metastatic Uveal Melanoma
The Clatterbridge Cancer Centre NHS Foundation Trust
2010-10 PHASE2
NCT01712490 COMPLETED
Hodgkin Lymphoma
Takeda
2012-11-09 PHASE3
NCT01476410 COMPLETED
Adult Lymphocyte Depletion Hodgkin Lymphoma; Adult Lymphocyte Predominant Hodgkin Lymphoma; Adult Mixed Cellularity Hodgkin Lymphoma; Adult Nodular Sclerosis Hodgkin Lymphoma; Stage II Adult Hodgkin Lymphoma; Stage III Adult Hodgkin Lymphoma; Stage IV Adult Hodgkin Lymphoma
Northwestern University
2011-11 PHASE2
NCT01705392 TERMINATED
Metastatic Malignant Melanoma; Unresectable Malignant Melanoma
Haukeland University Hospital
2013-01 PHASE2
NCT00526318 UNKNOWN
Neuroblastoma
German Society for Pediatric Oncology and Hematology GPOH gGmbH
2007-01
NCT02292979 COMPLETED
Hodgkin Lymphoma
The Lymphoma Academic Research Organisation
2015-03 PHASE2
NCT01845675 COMPLETED
Advanced Well-differentiated Pancreatic Neuroendocrine Tumor
Peking Union Medical College Hospital
2013-04 PHASE2
NCT01835145 COMPLETED
Recurrent Uveal Melanoma; Stage III Uveal Melanoma AJCC v7; Stage IIIA Uveal Melanoma AJCC v7; Stage IIIB Uveal Melanoma AJCC v7; Stage IIIC Uveal Melanoma AJCC v7; Stage IV Uveal Melanoma AJCC v7
National Cancer Institute (NCI)
2013-07-31 PHASE2
NCT01692678 COMPLETED
Advanced or Metastatic Liposarcoma or Leiomyosarcoma
Xian-Janssen Pharmaceutical Ltd.
2012-08-07 PHASE3
NCT02076646 UNKNOWN
Metastatic Melanoma Stage IV
Philogen S.p.A.
2013-07-31 PHASE1; PHASE2
NCT01143402 COMPLETED
Iris Melanoma; Medium/Large Size Posterior Uveal Melanoma; Ocular Melanoma With Extraocular Extension; Recurrent Uveal Melanoma; Small Size Posterior Uveal Melanoma; Stage IV Uveal Melanoma
National Cancer Institute (NCI)
2010-06 PHASE2
NCT00822120 COMPLETED
Lymphoma; Nonneoplastic Condition
SWOG Cancer Research Network
2009-07 PHASE2
NCT00920153 TERMINATED
Lymphoma
French Innovative Leukemia Organisation
2008-05 PHASE3
NCT01721746 COMPLETED
Unresectable or Metastatic Melanoma
Bristol-Myers Squibb
2012-12-21 PHASE3
NCT01132807 COMPLETED
Lymphoma
Alliance for Clinical Trials in Oncology
2010-05 PHASE2
NCT00678327 COMPLETED
Lymphoma
University College, London
2008-08-29 PHASE3
NCT02190838 TERMINATED
Melanoma
N.N. Petrov National Medical Research Center of Oncology
2014-04 PHASE2
NCT01763164 COMPLETED
Metastatic or Unresectable Cutaneous Melanoma
Pfizer
2013-07-12 PHASE3
NCT01704287 COMPLETED
Malignant Melanoma
Merck Sharp & Dohme LLC
2012-11-20 PHASE2
NCT01100528 COMPLETED
Ciliary Body and Choroid Melanoma, Medium/Large Size; Ciliary Body and Choroid Melanoma, Small Size; Iris Melanoma; Recurrent Intraocular Melanoma
Case Comprehensive Cancer Center
2009-11-11 PHASE2
NCT01974752 COMPLETED
Metastatic; Uveal Melanoma
AstraZeneca
2014-04 PHASE3
NCT01390584 TERMINATED
Lymphoma
ECOG-ACRIN Cancer Research Group
2013-05-24 PHASE2
NCT01327885 COMPLETED
Soft Tissue Sarcoma
Eisai Inc.
2011-03-10 PHASE3
NCT01534078 COMPLETED
Hodgkin Lymphoma
Massachusetts General Hospital
2012-03 PHASE2
NCT00802880 COMPLETED
Sarcoma
Washington University School of Medicine
2009-03 PHASE2
NCT01343277 COMPLETED
Advanced Liposarcoma or Leiomyosarcoma
Janssen Research & Development, LLC
2011-06 PHASE3
NCT01152788 COMPLETED
Melanoma
NCIC Clinical Trials Group
2010-08-05 PHASE2
NCT00849875 TERMINATED
Melanoma
GlaxoSmithKline
2009-05-26 PHASE2
NCT01692691 TERMINATED
Melanoma Metastatic
Western Regional Medical Center
2012-08 PHASE2
NCT00369681 COMPLETED
Lymphoma
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
2006-05 PHASE2
NCT01721772 COMPLETED
Melanoma
Bristol-Myers Squibb
2013-01-18 PHASE3
NCT01133977 COMPLETED
Stage IV Melanoma
Eisai Inc.
2010-04 PHASE1; PHASE2
NCT01681212 COMPLETED
Melanoma
Bristol-Myers Squibb
2012-10 PHASE2
NCT01614301 UNKNOWN
Advanced Melanoma
University of Regensburg
2012-05 PHASE1; PHASE2
NCT00797472 UNKNOWN
Hodgkin's Disease
American Scitech International
2011-07 PHASE2
NCT01569204 COMPLETED
Hodgkin Lymphoma
University of Cologne
2012-10 PHASE2
NCT00837148 COMPLETED
Sarcoma; Synovial Sarcoma; Leiomyosarcoma; Malignant Peripheral Nerve Sheath Tumor
Memorial Sloan Kettering Cancer Center
2009-02 PHASE2
NCT00433459 COMPLETED
Lymphoma
Christine Mauz-Körholz
2007-01 PHASE3
NCT01542255 TERMINATED
Metastatic Melanoma
Dartmouth-Hitchcock Medical Center
2010-06 PHASE2
NCT00779714 UNKNOWN
Melanoma
University of Wuerzburg
2008-10 PHASE3
NCT01060904 COMPLETED
Disease, Hodgkin
Seagen Inc.
2010-01 PHASE1
NCT00006237 COMPLETED
Melanoma (Skin)
SWOG Cancer Research Network
2000-08 PHASE3
NCT00864253 COMPLETED
Malignant Melanoma
Celgene
2009-04-23 PHASE3
NCT01164007 COMPLETED
Malignant Melanoma
Hoffmann-La Roche
2006-06-30 PHASE2
NCT00504504 COMPLETED
Lymphoma
M.D. Anderson Cancer Center
2001-03 PHASE2
NCT00395070 COMPLETED
Metastatic Melanoma
Vical
2006-10 PHASE3
NCT01468740 UNKNOWN
HIV-associated Hodgkin Lymphoma
Harlachinger Krebshilfe e.V.
2004-03 PHASE2
NCT01227889 COMPLETED
Cancer
GlaxoSmithKline
2010-12-23 PHASE3
NCT01404936 COMPLETED
Lymphoma
M.D. Anderson Cancer Center
1996-07 PHASE2
NCT00936221 COMPLETED
Melanoma
AstraZeneca
2009-07 PHASE2
NCT00089544 TERMINATED
Recurrent Adult Soft Tissue 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
National Cancer Institute (NCI)
2004-06-17 PHASE2
NCT00597038 COMPLETED
Metastatic Melanoma
H. Lee Moffitt Cancer Center and Research Institute
2007-11 PHASE1; PHASE2
NCT00991250 UNKNOWN
Malignant Melanoma
SentoClone AB
2009-10 PHASE2
NCT00002561 COMPLETED
Hodgkin Lymphoma
NCIC Clinical Trials Group
1994-01-25 PHASE3
NCT00518895 COMPLETED
Melanoma
Genta Incorporated
2007-07 PHASE3
NCT00533702 COMPLETED
Metastatic Malignant Melanoma
Eli Lilly and Company
2007-11 PHASE2
NCT01359956 COMPLETED
Malignant Melanoma; Recurrent Melanoma
National Cancer Institute, Naples
2002-04 PHASE3
NCT00410631 UNKNOWN
Neuroblastoma
German Society for Pediatric Oncology and Hematology GPOH gGmbH
2004-10 PHASE3
NCT00130442 COMPLETED
Melanoma
Cellxpert Biotechnology Corp.
2005-06 PHASE2
NCT00813449 UNKNOWN
Advanced Melanoma; Untreated Patients
Simcere Pharmaceutical Co., Ltd
2008-08 PHASE2
NCT00257205 COMPLETED
Melanoma
AstraZeneca
2006-03 PHASE3
NCT00498979 COMPLETED
Stage IV Melanoma
Case Comprehensive Cancer Center
2007-05 PHASE1
NCT00049595 COMPLETED
Lymphoma
European Organisation for Research and Treatment of Cancer - EORTC
2002-08 PHASE3
NCT01251107 COMPLETED
Hodgkin Lymphoma
Fondazione Michelangelo
2000-03 PHASE3
NCT00794235 COMPLETED
Melanoma Stage III or IV; No Prior Chemotherapy
University of Zurich
2008-12 PHASE2
NCT00580320 COMPLETED
Melanoma; Soft Tissue Sarcoma; Parathyroid Carcinoma; Small Cell Carcinoma of the Lung; Carcinoid Tumors
Virginia Commonwealth University
2004-09 PHASE1
NCT00516802 COMPLETED
Melanoma Neoplasms
AstraZeneca
2007-01 PHASE1
NCT00615160 TERMINATED
Melanoma
Michael Weichenthal
2006-12 PHASE1; PHASE2
NCT00246012 COMPLETED
Melanoma
Centocor, Inc.
2005-05 PHASE1; PHASE2
NCT00412581 COMPLETED
Melanoma
M.D. Anderson Cancer Center
2005-09 PHASE1
NCT01009177 COMPLETED
Melanoma
Actelion
2005-09-30 PHASE2
NCT00087776 TERMINATED
Malignant Melanoma
American Regent, Inc.
2002-12-06 PHASE3
NCT00911443 COMPLETED
Malignant Melanoma
sigma-tau i.f.r. S.p.A.
2002-07 PHASE2
NCT00003027 COMPLETED
Melanoma (Skin)
Eastern Cooperative Oncology Group
1997-11-13 PHASE3
NCT00496223 TERMINATED
Melanoma
H. Lee Moffitt Cancer Center and Research Institute
2006-09 PHASE1; PHASE2
NCT00543205 TERMINATED
Advanced Melanoma and Normal or Impaired; Hepatic Function
Genta Incorporated
2005-08 PHASE2; PHASE3
NCT00327600 COMPLETED
Malignant Melanoma
AmpliMed Corporation
2005-07 PHASE1; PHASE2
NCT00354523 TERMINATED
Solid Tumor; Thyroid Cancer
M.D. Anderson Cancer Center
2004-12 PHASE1; PHASE2
NCT00110994 COMPLETED
Cancer; Melanoma
Bayer
2005-04 PHASE2
NCT00070642 COMPLETED
Carcinoma, Melanoma
Pfizer
2003-12 PHASE2
NCT00039000 COMPLETED
Malignant Melanoma
Agenus Inc.
2002-03 PHASE3
NCT00005090 TERMINATED
Lymphoma
SWOG Cancer Research Network
2000-04 PHASE3
NCT00004010 COMPLETED
Lymphoma
Children's Oncology Group
1999-10 PHASE2
NCT00002882 COMPLETED
Melanoma; Skin Cancer
M.D. Anderson Cancer Center
1995-11 PHASE3
NCT00004141 COMPLETED
Melanoma (Skin)
University of Chicago
1998-08 PHASE2
NCT00002669 COMPLETED
Melanoma (Skin)
European Organisation for Research and Treatment of Cancer - EORTC
1995-06 PHASE2
NCT00002791 COMPLETED
Sarcoma
Radiation Therapy Oncology Group
1997-02 PHASE2
NCT00023738 COMPLETED
Sarcoma
Radiation Therapy Oncology Group
2001-08 PHASE1; PHASE2
NCT00041210 UNKNOWN
Lymphoma
Mount Vernon Cancer Centre at Mount Vernon Hospital
2001-10 PHASE3
NCT00559026 COMPLETED
Melanoma
Istituto Superiore di Sanità
2004-09 PHASE1
NCT00416377 UNKNOWN
Lymphoma
Children's Cancer and Leukaemia Group
NCT00542893 COMPLETED
Advanced Melanoma
Genta Incorporated
2006-04 PHASE1
NCT00000626 COMPLETED
HIV Infections; Hodgkin's Disease
National Institute of Allergy and Infectious Diseases (NIAID)
PHASE2
NCT00072124 COMPLETED
Melanoma (Skin)
National Cancer Institute (NCI)
2003-09 PHASE3
NCT00017225 COMPLETED
Neuroblastoma
German Society for Pediatric Oncology and Hematology GPOH gGmbH
1997-05 PHASE2
NCT00016263 COMPLETED
Melanoma (Skin)
Genta Incorporated
2000-07 PHASE3
NCT00226473 UNKNOWN
Metastatic Melanoma
Dermatologic Cooperative Oncology Group
2001-09 PHASE4
NCT00070343 UNKNOWN
Melanoma (Skin)
Jonsson Comprehensive Cancer Center
2003-08
NCT00002802 COMPLETED
Neuroblastoma
Children's Hospital Medical Center, Cincinnati
1990-07 PHASE3
NCT00099970 COMPLETED
Melanoma; Metastases
PDL BioPharma, Inc.
2004-12 PHASE2
NCT00006200 UNKNOWN
Melanoma
National Center for Research Resources (NCRR)
PHASE2
NCT00003421 COMPLETED
Lymphoma
Medical Research Council
1998-06 PHASE3
NCT00025064 UNKNOWN
Lymphoma
Children's Cancer and Leukaemia Group
2000-01 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-08-20)

Check the Dacarbazine product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As an alkylating agent, dacarbazine induces covalent DNA modification and cross-linking, which disrupts nucleic acid synthesis and triggers cell cycle arrest and apoptosis. This profound inhibition of cellular proliferation underlies its clinical efficacy in suppressing tumor growth across evaluated malignancies, including malignant melanoma, Hodgkin lymphoma, and soft tissue sarcomas.

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>).

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