Allopurinol: intravenous use for prevention and treatment of hyperuricemia.

Purpose: To tabulate data obtained over a 21-year period to determine the efficacy and safety of an intravenous (IV) allopurinol preparation.

Patients And Methods: IV allopurinol was provided on a compassionate plea basis to patients of any age in whom xanthine oxidase inhibitor therapy was indicated as an adjunct to chemotherapy and for whom oral intake was restricted. Three hundred twenty-seven investigators at multiple hospitals in the United States treated 1,172 patients with IV allopurinol.

A phase I study of a daily x3 schedule of intravenous vinorelbine for refractory epithelial ovarian cancer.

Purpose: To determine the toxicity and activity of intravenous vinorelbine given daily for 3 consecutive days every 3 weeks in patients with platinum-resistant epithelial ovarian cancer.

Patients And Methods: Between September 1994 and October 1995, 23 women with refractory epithelial ovarian cancer were entered onto this phase I study. All patients had measurable disease and platinum-resistant tumor, and prior therapy was limited to a maximum of two prior regimens.

Phase I study of vinorelbine and ifosfamide in advanced non-small-cell lung cancer.

Purpose: We designed a phase I dose-escalation study of vinorelbine on a novel (daily-times-three) schedule with ifosfamide with granulocyte colony-stimulating factor (G-CSF) support to define the dose-limiting toxicity (DLT) and maximum-tolerated dose (MTD) of vinorelbine in this combination.

Patients And Methods: Cohorts of patients with stage IIIB or IV non-small-cell lung cancer (NSCLC) and no prior chemotherapy received vinorelbine starting at 15 mg/m2 on days 1, 2, and 3, and ifosfamide starting at 2.0 g/m2 on days 1, 2, and 3 with G-CSF support for all patients.

Intraarterial administration of melphalan for treatment of intracranial human glioma xenografts in athymic rats.

Malignant gliomas will affect 15,000-17,000 Americans each year and carry a dismal prognosis. Adjuvant chemotherapy is hampered by inadequate drug delivery, systemic toxicity, and a markedly variable biological sensitivity. Intraarterial (i.

Intrathecal melphalan therapy of human neoplastic meningitis in athymic nude rats.

We report the activity and toxicity of intrathecal melphalan in the treatment of human neoplastic meningitis in the subarachnoid space of athymic nude rats. Animals received injections via chronic indwelling subarachnoid catheters with 5 x 10(5) or 5 x 10(6) TE-671 human rhabdomyosarcoma cells or 5 x 10(6) D-54 MG human glioma cells and were treated with melphalan on days 8, 5, or 5, respectively. Melphalan toxicity in nontumor-bearing rats was assessed at single doses of a 2.

A randomized, double-blind trial of fluorouracil plus placebo versus fluorouracil plus oral leucovorin in patients with metastatic colorectal cancer.

Purpose: A prospectively randomized trial was performed to determine whether the combination of fluorouracil (FU) plus leucovorin (FU-LV) administered orally is more effective than equitoxic FU for patients with metastatic colorectal cancer.

Patients And Methods: A double-blind, placebo-controlled trial design was used to eliminate observer bias. An escalating FU dosing schedule was used to achieve equal toxicity.

Cisplatin, 5-fluorouracil, and high-dose oral leucovorin for advanced head and neck cancer.

Both cisplatin and leucovorin may increase the activity of 5-fluorouracil (5-FU) by increasing the intracellular concentration of reduced folates. Therefore, a Phase I study was conducted in patients with recurrent or metastatic head and neck cancer in which high doses of oral leucovorin were added to the combination of cisplatin and 5-FU. Patients received intravenous cisplatin 100 mg/m2 on day 1, followed by a continuous intravenous infusion of 5-FU at 600 mg/m2/day for 5 days.

Clinical pharmacology of the stereoisomers of leucovorin during repeated oral dosing.

As part of a clinical trial of cisplatin, 5-fluorouracil (5-FU), and leucovorin (LV) for treatment of patients with advanced head and neck cancer, patients received 100 mg of LV (d,l-5-formyltetrahydrofolate) orally every 4 hours for 5 days. On days 2 and 4 of treatment, plasma samples were obtained 2 hours after (peak) and 30 minutes before (trough) a dose of LV. Total LV and 5-methyltetrahydrofolate (THF) concentrations were measured with high-performance liquid chromatography (HPLC) analysis.

Immunobiology of primary intracranial tumors. Part 10: Therapeutic efficacy of interferon in the treatment of recurrent gliomas.

Human lymphoblastoid alpha-interferon was administered intravenously or intramuscularly to 19 patients with recurrent gliomas. Each patient had previously undergone surgery and radiation therapy. The treatment course consisted of 8 weeks of therapy with an escalating daily dosage and number of days of treatment per week to a total dose of 900 X 10(6) U/sq m.

Interferon as adjuvant therapy with initial radiotherapy of patients with anaplastic gliomas.

In a group of nine patients with anaplastic gliomas, survival following surgery and treatment with interferon and radiotherapy was comparable to survival for a matched group of patients treated with BCNU and radiotherapy following surgery.

Immunobiology of primary intracranial tumors: IX. Phase I study of human lymphoblastoid interferon.

Interferon was administered intravenously on 3 consecutive days each week for 3 consecutive weeks in doses escalated each week from 10 to 20 to 30 megaunits (MU)/m2/day. Nine adult patients were treated, each of whom had undergone subtotal resection of a supratentorial anaplastic glioma within 3 weeks of beginning interferon treatment. Patients ranged in age from 34 to 71 years, and Karnofsky functional scores were 70 or greater.