WARNING
COSMEGEN® (Dactinomycin for Injection) should be administered only under the supervision of a physician who is experienced in the use of cancer chemotherapeutic agents.
This drug is HIGHLY TOXIC and both powder and solution must be handled and administered with care. Inhalation of dust or vapors and contact with skin or mucous membranes, especially those of the eyes, must be avoided. Avoid exposure during pregnancy. Due to the toxic properties of dactinomycin (e.g., corrosivity, carcinogenicity, mutagenicity, teratogenicity), special handling procedures should be reviewed prior to handling and followed diligently. Dactinomycin is extremely corrosive to soft tissue. If extravasation occurs during intravenous use, severe damage to soft tissues will occur. In at least one instance, this has led to contracture of the arms.
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COSMEGEN SUMMARY
Dactinomycin is one of the actinomycins, a group of antibiotics produced by various species of
Streptomyces.
Dactinomycin is the principal component of the mixture of actinomycins produced by
Streptomyces parvullus.
Unlike other species of
Streptomyces,
this organism yields an essentially pure substance that contains only traces of similar compounds differing in the amino acid content of the peptide side chains.
COSMEGEN, as part of a combination chemotherapy and/or multi-modality treatment regimen, is indicated for the treatment of Wilms' tumor, childhood rhabdomyosarcoma, Ewing's sarcoma and metastatic, nonseminomatous testicular cancer.
COSMEGEN is indicated as a single agent, or as part of a combination chemotherapy regimen, for the treatment of gestational trophoblastic neoplasia.
COSMEGEN, as a component of regional perfusion, is indicated for the palliative and/or adjunctive treatment of locally recurrent or locoregional solid malignancies.
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NEWS HIGHLIGHTS
Published Studies Related to Cosmegen (Dactinomycin)
Phase III trial of weekly methotrexate or pulsed dactinomycin for low-risk gestational trophoblastic neoplasia: a gynecologic oncology group study. [2011.03.01]
PURPOSE: There is no consensus on the best regimen for the primary treatment of low-risk gestational trophoblastic neoplasia (GTN)... CONCLUSION: The biweekly dactinomycin regimen has a higher CR rate than the weekly IM methotrexate regimen in low-risk GTN, a generally curable disease.
Comparison of pulse methotrexate and pulse dactinomycin in the treatment of low-risk gestational trophoblastic neoplasia. [2005.04]
Methotrexate and dactinomycin are efficient drugs in the treatment of patients with low-risk gestational trophoblastic neoplasia (LRGTN). To compare the effectiveness of these two drugs in LRGTN, 46 patients were randomised to receive weekly intramuscular methotrexate at 30 mg/m(2) (n = 28) or intravenous dactinomycin at 1.25 mg/m(2) every 2 weeks (n = 18)...
Randomized controlled trial of doxorubicin versus dactinomycin in a multiagent protocol for treatment of dogs with malignant lymphoma. [1998.10.01]
OBJECTIVE: To compare efficacy and toxicity of 2 multiagent chemotherapeutic protocols similar in all respects except that 1 incorporated dactinomycin and the other incorporated doxorubicin for treatment of dogs with malignant lymphoma... Despite the lower cost and lack of cardiotoxicity, dactinomycin is not an equivalent substitute for doxorubicin in the initial treatment of dogs with malignant lymphoma.
Comparison between single-dose and divided-dose administration of dactinomycin and doxorubicin for patients with Wilms' tumor: a report from the National Wilms' Tumor Study Group. [1998.01]
PURPOSE: The National Wilms' Tumor Study (NWTS)-4 was designed to evaluate the efficacy, toxicity, and cost of administration of different regimens for the treatment of Wilms' tumor (WT)... CONCLUSION: We conclude that patients treated with PI combination chemotherapy for LR or HR WT or clear cell sarcoma of the kidney have equivalent 2-year RFS to those treated with STD regimens. PI drug administration is recommended as the new standard based on demonstrated efficacy, greater administered dose-intensity, less severe hematologic toxicity, and the requirement for fewer physician and hospital encounters.
A randomized clinical trial of single-dose versus fractionated-dose dactinomycin in the treatment of Wilms' tumor. Results after extended follow-up. Brazilian Wilms' Tumor Study Group. [1994.06.15]
BACKGROUND. To verify the adequacy of a simplified chemotherapeutic regimen for the treatment of Wilms' tumor (WT), the authors conducted a clinical trial to compare the standard fractionated dose (15 mcg/kg x 5 days) of dactinomycin (AMD) with a single dose (60 mcg/kg x 1 day) administration of the drug...
Clinical Trials Related to Cosmegen (Dactinomycin)
Evaluating Dactinomycin and Vincristine in Young Patients With Cancer [Recruiting]
RATIONALE: Studying samples of blood and urine in the laboratory from patients with cancer
may help doctors learn how dactinomycin and vincristine affect the body and how patients
will respond to treatment.
PURPOSE: This laboratory study is evaluating how well dactinomycin and vincristine work in
treating young patients with cancer.
Addition of Ipilimumab (MDX-010) To Isolated Limb Infusion (ILI) With Standard Melphalan and Dactinomycin In The Treatment of Advanced Unresectable Melanoma of The Extremity [Recruiting]
The purpose of this study is to see the effect of adding a systemic study drug, Ipilimumab,
to two standard chemotherapy drugs, Melphalan and Dactinomycin. The study drug Ipilimumab is
an antibody to a normal protein found in the body, CTLA-4. This protein normally allows the
immune system (the body's natural defense system that helps fight infections) uses to quiet
an immune response. The study drug works by blocking this protein and allowing the immune
system to become more active. This study will investigate the effects, of combining ILI
(using two standard drugs to treat melanoma, Melphalan and Dactinomycin), with the study
drug, Ipilimumab on advanced Melanoma cancer.
A Pharmacokinetic Study of Actinomycin-D and Vincristine in Children With Cancer [Recruiting]
To obtain a preliminary characterization of the plasma PK and metabolites of actinomycin-D
in children with cancer.
Methotrexate or Dactinomycin in Treating Patients With Low-Risk Gestational Trophoblastic Neoplasia [Recruiting]
RATIONALE: Drugs used in chemotherapy, such as methotrexate and dactinomycin, work in
different ways to stop the growth of tumor cells, either by killing the cells or by stopping
them from dividing. It is not yet known whether methotrexate is more effective than
dactinomycin in treating gestational trophoblastic disease.
PURPOSE: This randomized phase III trial studies how well methotrexate works compared to
dactinomycin in treating patients with low-risk gestational trophoblastic neoplasia.
Intercontinental Multidisciplinary Registry and Treatment Optimization Study for Choroid Plexus Tumors [Recruiting]
This is a "tissue banking and data review" research study that also has a "clinical"
research part:
- The goal of the tissue banking part of this study is to store tissue in a research
tissue bank by the International Society for Pediatric Oncology (SIOP) at an
international reference center for choroid plexus tumors. The tissue will be used in
future research related to cancer.
- The goal of the data review part of this study is to collect information from the
medical records of patients with choroid plexus tumors, and to store the information in
SIOP databases for use in future research related to cancer.
- The goal of this clinical research study is to compare 4 chemotherapy treatments for
choroid plexus tumors. The safety and level of effectiveness of these study treatments
will be compared and studied. The study drugs include different combinations of
etoposide, carboplatin, vincristine, cyclophosphamide, methotrexate, doxorubicin,
cisplatin, dactinomycin, temozolomide, and irinotecan.
Reports of Suspected Cosmegen (Dactinomycin) Side Effects
Ototoxicity (4),
Breast Cancer in Situ (2),
Death (2),
Agitation (1),
Infection (1),
Tachycardia (1),
Neoplasm Progression (1),
Osteomyelitis (1),
Liver Disorder (1),
Rickets (1), more >>
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Page last updated: 2011-12-09
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