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PubMed1990

Severe hepatic toxicity after treatment with vincristine and dactinomycin using single-dose or divided-dose schedules: a report from the National Wilms' Tumor Study.

To evaluate the effect of dactinomycin (AMD) dose and schedule on the frequency of severe hepatic toxicity in unirradiated National Wilms' Tumor Study-4 (NWTS-4) patients, we reviewed the records of 154 children randomized to single-dose AMD and 176 children randomized to divided-dose AMD administration. All the children also received vincristine in identical dose schedules for the first 10 weeks. The frequency of severe hepatic toxicity encountered in the early weeks of therapy was 14.3% (five of 35) among patients treated with 60 micrograms/kg of AMD, 3.7% (four of 108) among patients given 45 micrograms/kg, and 2.8% (five of 176) among patients treated with 15 micrograms/kg per dose times five doses (P = .025). The data suggest an increased frequency of severe hepatic toxicity with the higher, single-dose schedule of administration. However, the frequency of severe hepatic toxicity among the patients in the two remaining groups is markedly higher than the 0.4% observed among similar unirradiated patients in NWTS-3. The relationship of this toxicity to factors such as anesthetic agents, blood transfusions, intercurrent viral infection, or other presently unrecognized causes can be further evaluated only with a detailed investigation such as a case-control study.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1998

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.

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). PATIENTS AND METHODS: Between August 6, 1986 and September 1, 1994, 1,687 previously untreated children less than 16 years of age with stages I to II/favorable histology (FH) or stage I/anaplastic histology WT (low-risk [LR] group) or stages III to IV/FH WT or stages I to IV/clear cell sarcoma of the kidney (high-risk [HR] group) were randomized to treatment that included vincristine and either divided-dose (standard [STD]) courses (5 days) or single-dose (pulse-intensive [PI]) treatment with dactinomycin. HR patients also received either STD courses (3 days) or PI treatment with doxorubicin. RESULTS: The 2-year relapse-free survival (RFS) rates for LR patients were 91.3% for 544 randomized to treatment with PI and 91.4% for 556 randomized to treatment with STD chemotherapy (P = .988). The 2-year RFS rates for HR patients were 87.3% for 299 randomized to treatment with PI and 90.0% for 288 randomized to treatment with STD chemotherapy (P = .865). 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.

Adolescent↗
PubMed2004

Age is a risk factor for chemotherapy-induced hepatopathy with vincristine, dactinomycin, and cyclophosphamide.

PURPOSE: To evaluate the spectrum of and determine the risk factors for the development of liver toxicity (hepatopathy) after therapy with vincristine, dactinomycin, and cyclophosphamide (VAC) for rhabdomyosarcoma in children and adolescents. PATIENTS AND METHODS: We prospectively captured all events of hepatopathy occurring on the ongoing Children's Oncology Group intermediate risk protocol, D9803, for children with rhabdomyosarcoma. Patients enrolled onto this trial were randomly assigned to receive either VAC alone or VAC alternating with vincristine, topotecan, and cyclophosphamide. In addition, we reviewed the toxicity database and requested additional information for all patients with elevated bilirubin or transaminase levels. Risk factors were analyzed. RESULTS: Of 339 patients enrolled through August 2002, 18 developed hepatopathy. All events were captured by mandated toxicity reporting and filing of MedWatch forms, with no additional cases found after the additional search of the database. Four children died after developing this toxicity. All cases occurred after cycles of VAC (n = 16) or vincristine and cyclophosphamide with concomitant abdominal radiotherapy (n = 2). The onset of hepatopathy was 5 to 16 days from the start of a treatment cycle. For the 89 patients under 36 months of age, the risk of hepatopathy was 15%, with two deaths. For the 239 children 3 years of age or older, the risk for hepatopathy was 4%, with two deaths. CONCLUSION: The greatest risk factor for development of hepatopathy after VAC therapy was age. Dose modifications for younger children receiving VAC therapy are recommended.

Age Factors↗
PubMed2006

A phase II trial of isolated limb infusion with melphalan and dactinomycin for regional melanoma and soft tissue sarcoma of the extremity.

BACKGROUND: Isolated limb infusion (ILI) is a minimally invasive technique of delivering regional chemotherapy in patients with advanced melanoma or soft tissue sarcoma of the limb. Reports from Australia of efficacy similar to that of isolated limb perfusion prompted us to conduct a phase II trial to evaluate the efficacy and safety of ILI. METHODS: Eligible patients had American Joint Committee on Cancer stage IIIB or IIIC melanoma or unresectable soft tissue sarcoma of the limb. Angiographic catheters were positioned just above the knee or elbow of the extremity. General anesthesia was performed, a proximal tourniquet was inflated, and a normothermic, low-flow, hypoxic infusion of melphalan and dactinomycin was circulated through the involved limb for 20 minutes. The tumor response was assessed by using standard criteria at 3 months. Morbidity was determined in the hospital and at 2, 6, and 12 weeks. RESULTS: Twenty-five patients were accrued to the trial, and 32 ILIs were performed (8 patients had 2 ILIs); 1 patient was not treated. Of the 22 assessable patients, 11 (50%) had a significant response at 3 months: 23% of patients had a complete response, and 27% of patients had a partial response. The median duration of complete response was 1 year (range, 6-32 months). Morbidity was acceptable. Peak morbidity occurred at 2 weeks and was considered moderate in most patients. Limb edema and erythema were common. No patient developed compartment syndrome or required amputation. CONCLUSIONS: ILI is well tolerated. Half of the patients experienced a complete or partial response.

Adult↗
PubMedDate not supplied

Ultrasound in the management of hepatic veno-occlusive disease in three children treated with dactinomycin and vincristine.

Three children, treated with dactinomycin and vincristine without radiotherapy showed hepatic toxicity consistent with diagnostic criteria for hepatic veno-occlusive disease (VOD). Two patients were affected with Wilms' tumor and the third with malignant fibromatosis. The clinical manifestations of VOD were mild and regressed in all patients after supportive therapy. Serial ultrasonography (US) was performed in all cases and was useful in confirming the diagnosis and in evaluating the severity of the disease. US features of VOD were hepatomegaly, gallbladder wall thickening, ill-defined borders of the hepatic vessels, and ascites. Parenchymal heterogeneity was still present after several months as a result of the hepatic injury. The hazy appearance of the portal vessels and the gallbladder wall thickening seemed directly correlated with the degree of hepatic involvement in the early phase of VOD.

Child↗
PubMed1991

[The effects and properties of sodium nucleinate as a pyrogen working-standard. 9. Pyrogen detection with epinephrine-skin-, dactinomycin- and LAL-tests. The suitability of sodium nucleinate as a pyrogen standard].

Sodium nucleinate (NN) as well as bacterial lipopolysaccharide (LPS) can be detected by epinephrine-skin, dactinomycin and LAL tests. In the quantitative determination of two pyrogen standards for rabbit tests, consisting of NN, a smaller value was found by LAL test for the standard of greatest pyrogenic effect than for that less pyrogenically effective in rabbits. A standard consisting of NN can be used for the pyrogen test in rabbits. But in the future, if necessary a standard consisting of endotoxin will be used, due to its better comparability of results obtained by LAL and rabbit tests.

Animals↗
PubMed1986

[Acute exanthematous eruption of multiple Kaposi sarcomas of the AIDS type in a female drug-addict. Successful chemotherapy with vincristine, bleomycin and dactinomycin].

In a 30-year-old German women who appeared to be in good general health, numerous Kaposi sarcomas of the AIDS type appeared on her face and trunk within a few days. Her arms, legs and oral mucosa were also affected. The patient has been a prostitute for more than 10 years and an i.v. drug addict for 5 years. Her face and upper trunk were densely covered with livid red tumors that were up to the size of coffee beans, with a longitudinal axis that followed the relaxed skin tension lines. HTLV III antibodies were present. No severe cellular immune defect could be demonstrated (OKT4 + to OKT8 + cell ratio 1.15; later control = 2.4). Recall antigens were negative. Since no severe immune defect was present, cytostatic therapy with vincristine, bleomycin and dactinomycin was carried out. Infiltrates began to regress after just one cycle. After four cycles, the facial lesions had completely disappeared. On the chest slight erythemas remained, but there were no histological signs of Kaposi sarcoma. On the legs there were still some solitary brown infiltrates. It was shown that the AIDS type of Kaposi sarcoma responds to combined chemotherapy.

Acquired Immunodeficiency Syndrome↗
PubMed1987

Actin synthesis in cultured cardiac myocytes: comparative effects of doxorubicin, dactinomycin, and plicamycin.

Cultured neonatal rat myocardial cells (CMC) were incubated with 10(-8) to 10(-5) mol/L doxorubicin (ADR), dactinomycin (ACT), and plicamycin (MIT), respectively, in medium containing 35 mu Ci sulfur 35-labeled methionine to determine comparative effects on myocardial contractile protein synthesis. Cells were harvested in 2 mmol/L Tris buffer with 0.1% Triton X-100, homogenized, and fractionated by centrifugation. Aliquots of the extracts containing equivalent amounts of protein were applied to 8% to 15% gradient sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE). Similar aliquots were subjected to isoelectric focusing and to gel electrophoresis in the second dimension. All electrophoretic gels were autoradiographed. A concentration-dependent effect of ADR, ACT, and MIT on protein and on actin synthesis was found in cultured myocytes with decreased density of radiolabeled actin band in CMC exposed to either 10(-5) mol/L ADR, or from 10(-8) to 10(-5) mol/L ACT, or from 10(-7) to 10(-5) mol/L MIT. Autoradiographs of two-dimensional gels focused actin isoforms but showed substantial decreases of all actin isoforms in CMC extracts from 10(-7) mol/L ACT. ACT and MIT each decreased CMC protein synthesis by 20% at 10(-8) mol/L. At 10(-6) mol/L ADR, synthesis of alpha-actin was diminished preferentially compared with beta and gamma. Synthesis of all actin isoforms was diminished at 10(-5) mol/L ADR. The effect of MIT and ACT on CMC actin and protein synthesis in heart cells is not as specific as the effect of ADR on CMC actin and protein synthesis.

Actins↗
PubMed1985

Quantitative correlations of biological activities of dactinomycin analogs and methotrexate derivatives with van der Waals volume.

The biological activities namely the ability to bind with DNA base pairs and the in vitro inhibition of human lymphoblastic leukemia cells of certain C-7- and N2-substituted dactinomycin (actinomycin D, AMD) analogs, and the growth inhibitory activity of a series of side chain substituted methotrexate (MTX) derivatives against L 1210 mouse leukemia cells in culture and their binding affinity for dihydrofolate reductase (DHFR) enzyme extracted from this system and L. casei are found to be significantly correlated with van der Waals volume of the substituents. In case of MTX derivatives, not only the side chain substituted analogs but certain ring substituted analogs, too, are shown to have their different activities dependent upon the Vw of the substituents. In case of side chain substituted analogs, however, it is found that the size of the substituent of alpha-position produces a greater effect on the activity than that of gamma-position. Based on the correlating equations obtained it is assumed that in these cases the drug-receptor interaction might be involving either hydrophobic interaction or the van der Waals type of interaction.

Animals↗
PubMedDate not supplied

Doxorubicin and dactinomycin therapy for advanced sarcomas.

Doxorubicin and dactinomycin were administered to 25 patients with advanced sarcomas. Twenty-one were evaluable for response. There were six responses (two complete and four partial) (28%) and eight improvements. Responders survived longer than nonresponders, while those with improvements had intermediate survival. Toxic effects included leukopenia in 35% of administered courses, mucositis in 50% of the patients, and congestive heart failure in 21% of the patients. Plasma doxorubicin kinetics did not correlate with excess toxic effects in four patients studied. The response rates and durations of survival obtained with this combination are comparable to those obtained with doxorubicin alone. The marked increase in toxicity makes this combination less desirable than treatment with doxorubicin alone.

Adolescent↗
PubMed1982

Clinical trial of chlorozotocin, DTIC, and dactinomycin in metastatic malignant melanoma.

Thirty evaluable patients with metastatic malignant melanoma were treated with a combination of chlorozotocin, DTIC, and dactinomycin. One complete and four partial responses were achieved, for an overall response rate of 17%. Cumulative myelotoxicity was noted, as well as universal gastrointestinal intolerance. One patient developed probable drug-related nephrotoxicity. A survival advantage was noted for responding patients. We conclude that the addition of chlorozotocin did not improve response rate or response duration and that further trials with this drug combination cannot be recommended.

Adolescent↗
PubMed1981

Late treatment of murine lupus erythematosus with dactinomycin. II. C1 and antibody to DNA.

(NZB x NZW)F1 hybrid (B/W) female mice were treated intermittently with dactinomycin beginning at 6--6.5 months of age. Survival was greatly prolonged relative to control mice. IgG antibody to DNA did not decline significantly in the treated mice until they were more than 18 months old, but circulating levels of the first complement component (Cl) rose during the first 4 weeks of treatment and were back into the normal range after 8 weeks. Thus these two humoral indexes of disease activity varied independently, and only Cl reflected the improved status of the treated mice.

Age Factors↗
PubMed1981

[Comparison of the efficacy of imidazole-carboxamide and of a combination of nitrosomethylurea, vincristine and dactinomycin in disseminated melanoma].

A randomized cooperative study comparing 2 regimens of chemotherapy (DTIC--150mg/m2 iv days 1, 2, 3, 4, 5 and a combination of vincristine--1.4 mg/m2 iv days 1, 8, 15, nitrosomethylurea--200 mg/m2 iv days 3, 5, 10, 12 and dactinomycin--0.3 mg/m2 iv days 1, 3, 5, 8, 10, 12) was carried out in 114 patients with disseminated skin melanoma. A combined chemotherapy course given to 58 patients was followed by complete response (CR) in 8 cases (13.7%) and partial response by over 50% (PR)--in 6 cases (10.4%). In 56 patients treated with DTIC, CR was registered in 4 patients (7.1%) and PR in 9 (16%). Patients resistant to one regimen did not respond to the other.

Adolescent↗
PubMedDate not supplied

Phase II study of vinblastine-CCNU, triazinate, and dactinomycin in advanced renal cell cancer.

A total of 133 patients with advanced or metastatic adenocarcinoma of the kidney were stratified according to performance status and time from initial diagnosis to recurrence and were then randomized to one of three different drug treatment arms or the crossover secondary treatment. The study drugs (combination vinblastine-CCNU and single-agent triazinate or dactinomycin) failed to provide any meaningful antitumor activity for these patients with advanced renal cell cancer.

Adenocarcinoma↗
PubMedDate not supplied

Tolerance to single-dose dactinomycin in combination chemotherapy for solid tumors.

We have reviewed our experience using single-dose dactinomycin (Act D). Twenty-nine patients with Ewing's sarcoma or rhabdomyosarcoma received 114 courses of Act D (2 mg/m2) in combination with vincristine, cyclophosphamide, or DTIC with or without radiotherapy. Side effects included nausea and vomiting (100% of the courses), severe thrombocytopenia (16%), granulocytopenia (18%), and mucositis (25%). In addition, skin reactions were observed in 74% of the courses following concomitant radiotherapy. These results were compared with those following 152 courses of combination chemotherapy which contained doxorubicin in place of Act D and which were administered to these same patients. It is concluded that single-bolus Act D is no more toxic, is at least as effective, and is more conveniently administered than the traditional divided daily dose of Act D.

Adolescent↗
PubMed1995

[Neoadjuvant treatment of Ewing's sarcoma: results obtained in 122 patients treated with a 6-drug chemotherapeutic protocol (vincristine, adriamycin, cyclophosphamide, dactinomycin, ifosfamide and etoposide)].

From January 1988 to October 1991, one hundred and twelve patients with non metastatic Ewing's sarcoma of bone were treated with a 6 drugs neoadjuvant chemotherapy protocol (IOR/Ew2) in which, to the four drugs usually used in the treatment of this tumor (vincristine, adriamycin, cyclophosphamide and dactinomycin), Ifosfamide and VP-16 were added. The local treatment consisted of radiation therapy in 52 cases, a surgical treatment was performed in 27 cases and in the remaining 33 cases both the previous treatments were used. At a mean follow-up of 4.5 years (3-6.5), 62 patients (55.3%) remained continuously free of disease and 50 relapsed: 41 with metastases, 8 with mestastases and local recurrence and 1 with local recurrence alone. These results do not differ from the ones obtained in our Institution in 98 patients treated between 1983 and 1988 with a neoadjuvant protocol (IOR/Ew1) in which only VCR, ADM, CTX and actD were used (3 year CDFS: IOR/Ew2 = 60.7%-IOR/Ew1 = 55.1%). In IOR/Ew2 a higher DFS rate was observed in the patients with tumor located in the axile bones in comparison with that obtained in the previous study (IOR/Ew2 = 48.6%, IOR Ew1 = 25.6%). Despite the fact that these results came from a not-randomized study, the authors conclude that the addition of Ifosfamide and VP-16 to the four drugs standard regimen do not improve the outcome of patients with Ewing's sarcoma of bone, with the possible exception of the patients with tumor located in the axile bones. This data should be confirmed in further and larger studies.

Adolescent↗