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Cosmegen (Dactinomycin) - Summary



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, 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.

See all Cosmegen indications & dosage >>


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...

more studies >>

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.

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.

Isolated Limb Infusion Chemotherapy With Targeted Gene Therapy for Advanced, Unresectable Extremity Melanoma [Not yet recruiting]
This phase I/II trial studies the safety, best dose and effectiveness of targeted gene therapy combined with isolated limb infusion (ILI) of melphalan and dactinomycin for treating patients with advanced extremity melanoma that cannot be removed by surgery. Adding gene therapy to a standard chemotherapy regimen in the isolated limb may enhance anti-cancer effects by inducing a systemic immune response against the tumor cells.

Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia [Active, not recruiting]
RATIONALE: 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.

PURPOSE: Randomized phase III trial to compare the effectiveness of methotrexate with that of dactinomycin in treating patients who have gestational trophoblastic neoplasia.

Dactinomycin in Treating Patients With Persistent or Recurrent Gestational Trophoblastic Neoplasia [Completed]
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of dactinomycin in treating patients who have persistent or recurrent gestational trophoblastic neoplasia.

more trials >>

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 >>

Page last updated: 2011-12-09

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