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.
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, Ewings 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.
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)
Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia [Completed]
Randomized phase III trial to compare the effectiveness of methotrexate with that of
dactinomycin in treating patients who have gestational trophoblastic neoplasia. Drugs used
in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or
die. It is not yet known whether methotrexate is more effective than dactinomycin in
treating patients with gestational trophoblastic neoplasia.
Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Low-Risk Rhabdomyosarcoma [Active, not recruiting]
This phase III trial is studying how well combination chemotherapy and radiation therapy
work in treating patients with newly diagnosed low-risk rhabdomyosarcoma. Drugs used in
chemotherapy, such as vincristine, dactinomycin, and cyclophosphamide, work in different
ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses
high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may
kill more tumor cells. It is not yet known which treatment regimen is more effective in
treating low-risk rhabdomyosarcoma.
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.
Combination Chemotherapy in Treating Patients With Previously Untreated Rhabdomyosarcoma [Completed]
This randomized phase III trial is comparing two different combination chemotherapy regimens
to see how well each works in treating patients with previously untreated rhabdomyosarcoma
or sarcoma. Drugs used in chemotherapy, such as dactinomycin, cyclophosphamide, vincristine,
and topotecan, use different ways to stop tumor cells from dividing so they stop growing or
die. It is not yet known which combination chemotherapy regimen is more effective in
Evaluating Dactinomycin and Vincristine in Young Patients With Cancer [Active, not recruiting]
This laboratory study is evaluating how well dactinomycin and vincristine work in treating
young patients with cancer. 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.
Reports of Suspected Cosmegen (Dactinomycin) Side Effects
Breast Cancer in Situ (2),
Neoplasm Progression (1),
Liver Disorder (1),
Rickets (1), more >>
Page last updated: 2011-12-09