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)
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...
Single-dose versus fractionated-dose dactinomycin in the treatment of Wilms' tumor. Preliminary results of a clinical trial. The Brazilian Wilms' Tumor Study Group. [1991.06.15]
A clinical trial was conducted by the Brazilian Wilms' Tumor (WT) Study Group to compare the single-dose (60 micrograms/kg x 1 day) administration of dactinomycin (AMD) with the standard fractionated dose (15 micrograms/kg/d x 5 days) used in the US National WT Study... Acute toxicity was observed in only one patient of the fractionated-dose group and in zero of the patients of the single-dose group.
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.
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 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.
Pharmacokinetics of Dactinomycin in Young Patients With Cancer [Recruiting]
RATIONALE: Studying samples of blood in the laboratory from patients with cancer receiving
dactinomycin may help doctors learn how dactinomycin works in the body and how patients will
respond to treatment.
PURPOSE: This laboratory study is evaluating the pharmacokinetics of dactinomycin in young
patients with cancer.
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