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Biomedical subjects

A Robertone

Publications and source records attributed to A Robertone.

8 recordsLinked to original sources
PubMed1988

Phase I-II trial of interferon-alpha 2b by continuous subcutaneous infusion over 28 days.

Interferon-alpha 2b (IFN-alpha) was administered by continuous subcutaneous (s.c.) infusion to 23 patients with hematologic malignancies or metastatic solid tumors: 5 patients with multiple myeloma, 3 with malignant melanoma, 2 with chronic myelogenous leukemia (CML), 10 patients with renal cell cancer, and 3 patients with other solid tumors. Drug was delivered by continuous s.c. infusion for 28 days (1 cycle) at daily dose levels of 0.7, 1.4, 2.5, 3.6, or 5.0 X 10(6) IU/m2 to 3, 3, 3, 8, and 6 patients, respectively. At the highest dose level, a severe flu-like syndrome was seen in 3 patients and severe gastrointestinal toxicity in 2 patients. The maximally tolerated dose (MTD) was 3.6 X 10(6) IU/m2.day and the principal toxicity was a mild to moderate flu-like syndrome. Local skin reactions were occasionally noted at all dose levels if the s.c. needle site was not rotated every 3-4 days. At dose levels of 2.5-3.6 X 10(6) IU/m2.day, IFN-alpha serum levels at steady state ranged from 19 to 61 IU/ml. The time to achieve steady-state conditions ranged from 40 to 72 h and at steady state, 24 h area under the concentration time curve (AUC24 h) ranged from 480 to 1,464 IU/ml.h. Objective responses were seen 3 of 17 evaluable patients: 1/7 in renal cell cancer (14%); 1/2 in CML and in one patient with ependymoma. Remissions lasted 4, 8, and 15 months in renal cell, CML, and ependymoma, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1987

High incidence of local venous reactions to esorubicin.

A retrospective analysis was performed on the medical charts of 160 cancer patients who received esorubicin (ESO or 4'deoxydoxorubicin) in a Phase I clinical trial. The purpose of the review was to characterize the incidence of local venous reactions to this investigational doxorubicin (DOX) analog. The impact of prophylactic pretreatments of post-treatment using antihistamines and glucocorticosteroids was also assessed. There were 58 episodes of local reactions to ESO injections (14.3%). These reactions were characterized by local swelling, itching and erythema. Like DOX-induced venous reactions, ESO complications resolved spontaneously after several hours and did not predispose patients to skin ulceration or subsequent general hypersensitivity reactions. Indeed, ESO reactions were more common with initial treatments at low drug doses of only 10-15 mg/M2 (p less than .05 by Chi-square analysis). One case of ESO extravasation (about 5mg) was successfully managed with topical cooling. The use of antihistamines and corticosteroids was ineffective at preventing local reactions. However, when these drugs were administered after a reaction had ensued, symptoms were lessened significantly in half of the patients treated (p less than .05). The results of this review suggest that ESO causes a four-fold greater incidence of local venous reactions than with the parent DOX.

Adult↗
PubMed1987

Phase II study of interferon alfa-2a, recombinant (Roferon-A) in metastatic renal cell carcinoma.

In an attempt to decrease toxicity without compromising efficacy, 22 patients with locally advanced or metastatic renal cell carcinoma (RCC) were treated with recombinant interferon alfa-2a (rIFN alpha 2a, Roferon-A; Hoffman-LaRoche, Nutley, NJ) intramuscularly (IM) beginning at a dose of 3 X 10(6) U/d with incremental dose escalations to the highest dose of 36 X 10(6) U/d if tolerated, for a total induction period of 10 weeks. Patients demonstrating complete (CR), partial (PR), or minor (MR) responses or stabilization were continued on a maintenance regimen of the highest tolerated dose administered three times weekly until disease progression. Doses administered during maintenance were individually determined as the maximum dose that resulted in only mild toxicity. No CRs were achieved. Partial responses were observed in 23% of the patients with a median duration of response of 8.0 months (range, 1 to 17+). The majority of interferon side effects were seen during the induction phase, which was also the period requiring the most frequent adjustments in dose. In comparison to another study using similar toxicity criteria, overall toxicity was reduced in severity, most probably due to the study design, which allowed individual tailoring of doses. The use of an initial induction phase employing rapid dose escalation followed by a well-tolerated maintenance phase appeared to be a reasonable strategy. The therapeutic results to date represent a modest advance. An optimal dosage, route, and schedule for interferon administration for metastatic renal cancer is not yet clearly established.

Carcinoma, Renal Cell↗
PubMed1986

Phase II trial of esorubicin (4' deoxydoxorubicin) in cancers of the breast, colon, kidney, lung and melanoma.

A phase II trial of esorubicin (4' deoxydoxorubicin) was performed in patients with cancers of the breast, colon, kidney, lung and melanoma. Two partial responses were observed out of 16 patients with breast cancer treated with esorubicin. No objective responses (complete or partial) were seen in patients with colon cancer (18 patients), lung cancer (12 patients), renal cell cancer (12 patients) and melanoma (18 patients). Myelo-suppression was the most significant toxicity encountered with granulocytopenia (neutrophils less than 1,000) observed in 38% of patients. As discussed, we feel that further investigation of esorubicin in anthracycline-sensitive tumors is warranted.

Adult↗
PubMed1986

Phase II trial of 4'-deoxydoxorubicin (esorubicin) in hormone resistant prostate cancer.

Fifteen patients with hormone resistant advanced prostate cancer were treated with anthracycline analog 4'-deoxydoxorubicin (Esorubicin). No patient had objective evidence of tumor regression. Six patients (40%) were classified using the National Prostatic Cancer Project criteria as having stable disease after two courses of therapy. Treatment was associated with significant hematologic toxicity with 50% of patients experiencing grade III or IV neutropenia. Clinical cardiac toxicity was not observed. Further trials of 4'-deoxydoxorubicin do not appear to be warranted in advanced prostate cancer.

Doxorubicin↗
PubMed1986

Controlled studies of a new microprocessor-based portable infusion pump.

A new microprocessor-controlled portable infusion pump, the Pancretec Provider IV 2000 TM was tested in vitro and in vivo in cancer patients. The Provider is a rotary peristaltic, battery-powered pump capable of flow rates of 0.2 to 83 ml/hour with delivery volumes up to 1999 ml. Two programming modes are available: intermittent infusion and continuous infusion. Bench tests showed the flow rate accuracy to be within 96% of the desired rate. Flow rate precision was similarly excellent at +/- 2%. Clinical studies were performed in 14 ambulatory patients receiving continuous infusion antineoplastic or analgesic drugs over 5-60 days as outpatients. The majority of infusions delivered fluoropyrimidines via indwelling central venous access ports. Two of the patients received long term (60 days) continuous infusion of analgesics for pain control. Flow rate accuracy with the pumps was within +/- 5% in 90% of the 27 infusion courses (244 patient-days of continuous infusion therapy). A significant therapy deviation (interruption 10% of the desired course) occurred in three instances. One related to a procedural error (incomplete cartridge insertion into the pump), two were caused by fluid leakage which interrupted pump function. Defect alarms (both visual and audible) operated in both instances. A KVO flow rate of 0.1 ml/hr was also found to be adequate to maintain catheter patency in peripheral veins over a 24-hour period in two normal volunteers. We conclude that the Provider pump is an accurate, reliable and state of the art infusion system with wide clinical applicability.

Adult↗
PubMed1984

Phase I trial of esorubicin (4'deoxydoxorubicin).

A phase I study of 4'deoxydoxorubicin (esorubicin) was performed on an every-21-day bolus intravenous (IV) schedule in 36 patients with advanced cancer. Thirty-four patients were evaluable for toxicity analysis. Toxicity included mild nausea, occasional local skin reactions, and mild to moderate alopecia. Myelo-suppression was dose limiting. Clinically evident congestive heart failure was not observed. However, two patients developed premature ventricular contractions. Overall, esorubicin was better tolerated than doxorubicin at equally potent doses. Although response analysis was not the primary objective of this phase I study, minor responses were observed in melanoma, breast cancer, lymphoma, and gastric cancer. On the basis of this study, a starting dose of 30 mg/m2 IV every 21 days is recommended for good-risk patients with escalation to 32.5 mg/m2 depending on bone marrow tolerance. For patients with poor bone marrow reserve, a starting dose of 25 mg/m2 every 21 days is recommended. Phase II trials with esorubicin in this dosage schedule are clearly warranted in a wide variety of metastatic neoplasms including a substantial population of patients who have not received prior chemotherapy.

Adult↗