PHASE-II STUDY OF VP-16-213 IN CHILDHOOD MALIGNANT DISEASE - CHILDRENS CANCER STUDY-GROUP REPORT

  • 1 January 1979
    • journal article
    • research article
    • Vol. 63  (11-1) , 1755-1759
Abstract
VP-16-213, a semisynthetic podophyllotoxin, was tested for antitumor and clinical toxicity in 122 children. The drug was administered i.v. daily .times. 5 days every 2 wk at a starting dose of 75 mg/m2/day. The dose was increased by 25 mg/m2/day/course until clinical response or significant toxicity occurred. The only major toxicity was hematologic, with neutropenia as the most predominant feature. There was 1 local allergic reaction at the site of injection. No systemic allergic responses were reported. The drug demonstrated significant activity in acute myelomonocytic leukemia with 4 responses among 19 patients, less activity in acute myelocytic leukemia with 2 responses among 44 patients, and little activity in acute lymphocytic leukemia with only 1 partial response among 12 patients. Objective partial responses occurred in 10 of 48 patients with solid tumors: 2 each with Wilms'' tumor, lymphoma and histiocytosis X, and 1 each with rhabdomyosarcoma, neuroblastoma, Ewing''s sarcoma and undifferentiated carcinoma. The inclusion of VP-16-213 in combination chemotherapy for childhood acute myelomonocytic leukemia and acute myelocytic leukemia appears indicated in patients relapsing after initial therapy. For solid tumors this is an interim report, with further patient accrual required before specific comments can be made.

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