indicine-n-oxide has been researched along with Leukemia* in 4 studies
1 trial(s) available for indicine-n-oxide and Leukemia
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Phase II trial of indicine N-oxide in relapsed acute leukemia of childhood. A report from the Childrens Cancer Study Group.
We treated 31 children with acute lymphoblastic leukemia (ALL), 14 children with acute nonlymphoblastic leukemia (ANLL) in relapse, and 1 child with chronic myelogenous leukemia (CML) in blast crisis (CALLA negative) with indicine N-oxide in a Phase II study. The efficacy and toxicity of the drug were assessed at two dose levels: 2,000 mg/m2/day for 5 consecutive days (14 patients) and 2,500 mg/m2/day for 5 consecutive days (17 patients). One patient with ALL at each dose level achieved a complete response (CR) lasting 6 months and 1 month, respectively. The patient with CML achieved a partial response lasting 4 months. None of the patients with ANLL achieved a CR. Hepatotoxicity was mild (grade 1 or 2) in 63% and moderate (grade 3) in 9% of mild (grade 1 or 2) in 63% and moderate (grade 3) in 9% of patients; 3 patients (9%) experienced severe hepatotoxicity. Although indicine N-oxide has some antileukemic activity in ALL and is safe at the doses used in this study, the antileukemic activity is significantly less at these two doses than at greater than or equal to 3,000 mg/m2/days for 5 consecutive days. Unfortunately, when the higher doses are administered to children, they are associated with an unacceptably high incidence of severe, irreversible hepatotoxicity. Topics: Acute Disease; Antineoplastic Agents, Phytogenic; Child; Drug Evaluation; Humans; Leukemia; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Pyrrolizidine Alkaloids | 1992 |
3 other study(ies) available for indicine-n-oxide and Leukemia
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Phase I trial of indicine-N-oxide in children with leukemia and solid tumors: a Pediatric Oncology Group study.
A phase I trial of indicine-N-oxide was carried out in 12 children with solid tumors and in 16 with leukemia. Doses of 5, 6, and 7.5 g/m2 were given parenterally as a 15-min infusion every 3 weeks. The maximum tolerated dose in patients with solid tumors was 7.5 g/m2 and the dose-limiting toxicity was myelosuppression. In leukemia, the maximum tolerated dose was 6.0 g/m2 and hepatotoxicity was dose-limiting. Half of the children with leukemia showed elevations in transaminase levels and one child died of massive hepatic necrosis. This hepatotoxicity limits the use of indicine-N-oxide in children with leukemia. Antineoplastic activity was limited to a transient reduction in the numbers of circulating leukemic cells. Topics: Adolescent; Antineoplastic Agents, Phytogenic; Child; Child, Preschool; Drug Administration Schedule; Drug Evaluation; Humans; Infusions, Intravenous; Leukemia; Liver; Male; Neoplasms; Pyrrolizidine Alkaloids; Thrombocytopenia | 1990 |
High incidence of veno-occlusive disease related to indicine N-oxide in the treatment of refractory adult acute leukemia.
Topics: Acute Disease; Adult; Aged; Antineoplastic Agents, Phytogenic; Autopsy; Chemical and Drug Induced Liver Injury; Female; Humans; Leukemia; Leukemia, Lymphoid; Leukemia, Myeloid, Acute; Male; Middle Aged; Pancytopenia; Pyrrolizidine Alkaloids; Vascular Diseases | 1986 |
Hepatocellular toxicity during the treatment of refractory acute leukemia with indicine N-oxide.
Indicine N-oxide is the first member of the large class of compounds comprised of pyrrolizidine alkaloids and their N-oxides to be studied in the treatment of cancer in humans. Twenty-two patients with refractory acute leukemia received indicine N-oxide daily for 5 consecutive days in a dose-seeking study. Of eight patients with refractory acute lymphocytic leukemia, one had a complete remission, and one had a partial remission. Of 11 patients with refractory acute nonlymphocytic leukemia, 2 patients had complete remissions. Of three patients with blast crisis of chronic granulocytic leukemia, one patient had a partial remission. Five patients had severe hepatic toxicity, probably due to veno-occlusive disease induced by the drug. Whether hepatotoxicity and antileukemic activity are a result of the same mechanism of action of indicine N-oxide is not known. Topics: Acute Disease; Adolescent; Adult; Aged; Antineoplastic Agents, Phytogenic; Child; Child, Preschool; Drug Administration Schedule; Drug Resistance; Female; Humans; Leukemia; Leukemia, Lymphoid; Leukemia, Myeloid, Acute; Male; Middle Aged; Pyrrolizidine Alkaloids | 1984 |