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)
Mechanism and Biochemical Profile
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>).