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Biomedical subjects

E Eisenhauer

Publications and source records attributed to E Eisenhauer.

At least 19 recordsLinked to original sources
PubMed2006

Temozolomide in metastatic breast cancer (MBC): a phase II trial of the National Cancer Institute of Canada - Clinical Trials Group (NCIC-CTG).

BACKGROUND: Temozolomide is an oral alkylating agent that crosses the blood-brain barrier, and has preclinical activity in breast cancer. This phase II trial sought to determine the activity and toxicity of temozolomide in metastatic breast cancer (MBC). Temozolomide was administered in a dose dense schedule of 150 mg/m(2) on days 1-7 and 15-21 in a 28-day cycle. MATERIALS AND METHODS: Patients had unidimensional disease for response assessment by RECIST criteria, up to two prior chemotherapy regimens for MBC, and may have had brain metastases if radiation was not expected to be required within 4 weeks. RESULTS: Nineteen women were entered on the study. All were evaluable for toxicity and 18 were evaluable for response. The median age was 54 years; 14 had prior chemotherapy for MBC and 12 had prior hormones. Sites of disease included bone, brain, liver and lung. Treatment was well tolerated with 14/19 receiving >90% planned dose intensity. Common grade 1-3 drug-related effects included nausea, fatigue, vomiting, anorexia and skin rash. Grade 3-4 hematologic toxicities included granulocytopenia and thrombocytopenia. Of the 18 evaluable patients, there were no objective responses; three had stable disease and 15 progressive disease. CONCLUSIONS: No responses to temozolomide were documented in these heavily pretreated women with extensive MBC including brain metastases.

Administration, Oral↗
PubMed2006

SarCNU in recurrent or metastatic colorectal cancer: a phase II study of the National Cancer Institute of Canada Clinical Trials Group.

PURPOSE: To evaluate the activity and toxicity of SarCNU, an oral chloroethylnitrosourea in patients with recurrent or metastatic colorectal cancer who have progressed after first-line chemotherapy. PATIENTS AND METHODS: Eighteen patients with recurrent or metastatic colorectal cancer following first-line chemotherapy were treated with SarCNU 860 mg/m2 orally day 1, 5 and 9 every 6 weeks. The patient's median age was 64 and the ECOG performance status was 0 in six, 1 in eleven and 2 in one patients. All patients were evaluable for toxicity and 16 were evaluable for response. RESULTS: There were no objective responses (0%). One patient had stable disease and 15 had progressive disease at their first follow-up assessment. Median survival was 7.36 months (3.75-7.49 95% C.I.). Neutropenia and thrombocytopenia were the most severe toxicities (grade 3-4 in six and nine patients respectively). Pulmonary toxicity was also seen in five patients who had a drop of DLCO grade from baseline and two patients who had a fall in FVC from baseline. CONCLUSIONS: SarCNU is inactive in recurrent or metastatic colorectal patients who have progressed after first-line chemotherapy.

Adult↗
PubMed2006

A phase II study of perifosine (D-21226) in patients with previously untreated metastatic or locally advanced soft tissue sarcoma: A National Cancer Institute of Canada Clinical Trials Group trial.

UNLABELLED: BACKGROUND/PATIENTS AND METHODS: 16 adult patients with untreated measurable locally advanced or metastatic inoperable soft tissue sarcoma were treated with oral perifosine, a synthetic alkylphospholipid, believed to inhibit MAP kinase (MAP-K), protein kinase C (PKC), Akt and other regulatory proteins. Perifosine was administered orally in cycles for 21 days out of 28. Loading doses were given day 1 each cycle (900 mg cycle 1, 300 mg cycle 2+) and 150 mg daily was given days 2-21 of each cycle. Cycles were repeated until disease progression, unacceptable toxicity or patient refusal. RESULTS: Seventeen patients were enrolled; 16 and 15 were evaluable for toxicity and response, respectively. A total of 30 cycles of perifosine were administered. Most toxic effects were grade 1 or 2 and commonly included nausea, vomiting, diarrhea, and fatigue (> or =40%). Hematologic toxicity was generally mild. There were no significant biochemical abnormalities due to the drug reported. There were 4 serious adverse events (SAE)-none of which was related to perifosine. No objective responses were seen; 4 patients had stable disease for 1.3 to 8.2 months and the remainder of the patients had progressive disease. CONCLUSIONS: Perifosine when given according to this dosing schedule does not show evidence of activity in a mixed population of adult soft tissue sarcoma patients.

Academies and Institutes↗
PubMed2004

A phase 1 study of OSI-211 given as an intravenous infusion days 1, 2, and 3 every three weeks in patients with solid cancers.

PURPOSE: To define the maximum tolerated dose (MTD), recommended phase II dose (RD) and dose limiting toxicity (DLT) of liposomal lurtotecan, OSI-211 (formerly known as NX211), given as a short intravenous infusion on days 1, 2, and 3 every three weeks. EXPERIMENTAL DESIGN: Thirty-seven patients were enrolled and treated in a dose escalation study from a starting dose of 0.15 mg/m(2) daily x 3 to 2.1 mg/m(2) daily x 3. Detailed pharmacokinetic analyses of blood were done on both days 1 and 3 of the first cycle and toxicity was monitored. RESULTS: Two MTDs were defined; one for patients defined as minimally pretreated and one for those heavily pretreated. Dose limiting toxicity was myelosuppression: primarily thrombocytopenia although neutropenia was also noted. The MTD was 2.1 mg/m(2)/d (total dose of 6.3 mg/m(2)) in minimally pretreated patients and 1.8 mg/m(2)/d (5.4 mg/m(2) total dose) in heavily pretreated patients. Pharmacokinetics revealed that AUC and C (max) increased with dose and were significantly higher than that of free lurtotecan (AUC approx. 100 fold higher). The half life and duration of the active lactone form were also significantly longer than historical data on free drug. Two partial responses were seen, one each in a patient with breast and ovarian cancer. CONCLUSIONS: Two Phase II recommended doses were established for OSI-211 given as a daily x 3 schedule every three weeks. The recommended phase II dose is 1.8 mg/m(2) daily x 3 for minimally pretreated patients and 1.5 mg/m(2) for those heavily pretreated. Phase II studies should be initiated in sensitive tumours.

Adult↗
PubMed2004

A phase I study of OSI-211 and cisplatin as intravenous infusions given on days 1, 2 and 3 every 3 weeks in patients with solid cancers.

BACKGROUND: OSI-211 (also known as NX211) is a liposomal preparation of the topoisomerase I inhibitor, lurtotecan, which has shown antitumor activity in phase I and II clinical trials. Cisplatin is a widely used antineoplastic agent with activity in a broad range of tumor types. This phase I trial was conducted to determine the recommended doses of these agents, and their pharmacokinetic properties and toxicities in patients with advanced solid malignancies. PATIENTS AND METHODS: Fourteen patients with advanced and/or metastatic solid malignancies were enrolled in this trial. The first planned dose level was OSI-211 0.9 mg/m(2) with cisplatin 25 mg/m(2) administered intravenously daily for the first three consecutive days of a 21-day cycle. Patients were evaluated for hematological and non-hematological toxicities, and pharmacokinetic studies were performed on both agents. RESULTS: The recommended phase II dose was determined to be 0.7 mg/m(2) OSI-211 given with 25 mg/m(2) cisplatin. Dose-limiting neutropenia was seen in two of three patients at the starting dose level. Three of 11 patients at the second (lower) dose level experienced dose-limiting thrombocytopenia; febrile neutropenia was also seen in one patient. Non-hematological toxicities were generally manageable and included fatigue, nausea and vomiting. Considerable variability was seen in both hematological toxicities and pharmacokinetics. One complete response and three partial responses were seen. CONCLUSIONS: The recommended phase II dose for this combination is 0.7 mg/m(2) OSI-211 with 25 mg/m(2) cisplatin given as an intravenous infusion on days 1, 2 and 3 of a 21-day cycle. The main toxicity was myelosuppression. Preliminary evidence of antitumor activity was seen.

Adult↗
PubMed2003

Phase II study of CGP 69846A (ISIS 5132) in recurrent epithelial ovarian cancer: an NCIC clinical trials group study (NCIC IND.116).

OBJECTIVE: ISIS 5132 is a 20-base phosphorothioate DNA oligonucleotide against human c-raf kinase, a downstream effector of ras oncogene function. C-raf kinase is a molecule in the MAP kinase signaling cascade which is essential for cellular proliferation, the overexpression of which leads to malignant expression. Activity of this compound was documented in a woman with ovarian cancer in a Phase I study. METHODS: We evaluated ISIS 5132 at a dose of 4 mg/kg/day by continuous venous infusion, administered for 21 days q 4 weeks in 22 patients with recurrent ovarian cancer in a standard two-stage Phase II design. Three patients were ineligible; 19 patients are evaluable for toxicity and 16 for response. All patients had previously received systemic therapy for ovarian cancer (6 had one and 13 had two prior regimens). Patients were treated with a median of two cycles and 79% of the patients received >90% planned dose intensity. RESULTS: ISIS 5132 was well tolerated with no episodes of Grade 3 or 4 hematologic or biochemical (creatinine, AST, bilirubin) toxicity. There were six episodes of grade 3 nonhematologic toxicity in 4 patients thought to be treatment related (lethargy 2; anorexia 1; abdominal pain 2; shortness of breath 1). No responses were seen in the 16 patients who are evaluable for response; 4 had stable disease for a median of 3.8 months and 12 patients had documented progressive disease. CONCLUSION: ISIS 5132 at 4 mg/kg/day as a single agent did not show activity in recurrent ovarian cancer.

Adult↗
PubMed2002

DNA methyltransferase inhibitors-state of the art.

BACKGROUND: DNA methylation is the addition of a methyl group to the 5 position of cytosine. It is an epigenetic process with several effects, including chromatin structure modulation, transcriptional repression and the suppression of transposable elements. In malignancy, methylation patterns change, resulting in global hypomethylation with regional hypermethylation. This can lead to genetic instability and the repression of tumor suppressor genes. DESIGN: A review of the DNA methyltransferase inhibitor literature was conducted. RESULTS: DNA methylation inhibitors have demonstrated the ability to inhibit hypermethylation, restore suppressor gene expression and exert antitumor effects in in vitro and in vivo laboratory models. Four inhibitors, which are analogs of the nucleoside deoxycitidine, have been clinically tested: 5-azacytidine, 5-aza-2'-deoxycytidine, 1-beta-D-arabinofuranosyl-5-azacytosine and dihydro-5-azacytidine. The first two have demonstrated encouraging antileukemic activity but little activity in solid tumors, while the latter two are no longer under study due to lack of efficacy. A fifth agent, MG98, is an antisense oligodeoxynucleotide directed against the 3' untranslated region of the DNA methyltransferase-1 enzyme mRNA, and is now under phase II study. CONCLUSIONS: While some positive clinical results with DNA methyltransferase inhibitors have been seen, a definitive clinical role for these agents will most likely require combination therapy, and good phase III studies are needed.

Animals↗
PubMed2001

Phase II study of pemetrexed disodium, a multitargeted antifolate, and cisplatin as first-line therapy in patients with advanced nonsmall cell lung carcinoma: a study of the National Cancer Institute of Canada Clinical Trials Group.

BACKGROUND: Pemetrexed disodium (Alimta [Eli Lilly and Company, Indianapolis, IN], LY231514, multitargeted antifolate) is a new multitargeted antifolate agent that inhibits multiple enzymes in the folate pathway. Phase II trials showed single-agent response rates of 16% and 23% in untreated patients with nonsmall cell lung carcinoma (NSCLC). This study was undertaken to determine the response to pemetrexed disodium given in combination with cisplatin. METHODS: Previously untreated patients were eligible if they had Stage IIIB or IV NSCLC, performance status 0, 1, or 2, adequate hematology and biochemistry and bidimensionally measurable lesions. Patients with brain metastases or neuropathy higher than Grade 2 were excluded. Pemetrexed disodium 500 mg/m(2) was given over 10 minutes, and cisplatin 75 mg/m(2) with hydration and mannitol diuresis was administered on Day 1 of each 21-day cycle. Dexamethasone 4 mg was taken orally once every 12 hours starting 24 hours before treatment and continuing for 6 doses after treatment. Four patients had detailed pemetrexed disodium pharmacokinetic analysis performed. RESULTS: Between May 1998 and June 1999, 31 patients were treated on the study. There were 20 males and 11 females; median age was 60 years (range, 35-75 years); there were 5 Stage IIIB, 26 Stage IV, 26 performance status 0 or 1, and 5 performance status 2. In 29 patients evaluable for response, there were 13 partial responses (PRs; overall response rate [ORR], 95%; confidence interval [CI]: 26-64%) of median duration 6.1 months (1.6-7.8 months). Three of four evaluable patients with performance status 2 achieved PR, and 11 of 24 evaluable Stage IV patients responded (ORR, 45.8% in Stage IV). Eighteen patients died. The median survival rate was 8.9 months (range, 1-15+ months). A total of 160 courses were delivered (median, 6 for both cisplatin and pemetrexed disodium). Grade 3 and 4 anemia was observed in 5 and 1 patients, respectively, and Grade 3 and 4 granulocytopenia in 7 and 4 patients, respectively. Grade 3 nausea and emesis occurred in only 2 patients, Grade 3/4 diarrhea in 3 patients, and 2 patients had Grade 3 motor neuropathy. Nine patients had Grade 2 infections, and there was one case of febrile neutropenia. Pharmacokinetic results showed C(max), clearance and V(ss) values to be similar to data from single-agent pemetrexed disodium given in the same dose. CONCLUSIONS: The combination of pemetrexed disodium and cisplatin is active against advanced NSCLC and is a well-tolerated convenient outpatient regimen. It deserves further study to compare it with other standard regimens for NSCLC.

Adult↗
PubMed2001

Application of a new multinomial phase II stopping rule using response and early progression.

PURPOSE: A multinomial stopping rule had previously been developed that incorporated both objective response and early progression into decisions to stop or continue phase II trials of anticancer agents. The purpose of this study was to apply the multinomial rule to two independent sets of phase II data to assess its utility in appropriately recommending early trial closure as compared with other stopping rules. MATERIALS AND METHODS: Data from completed phase II trials of the National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) and European Organization for Research and Treatment of Cancer Early Clinical Studies Group (ECSG) formed the basis of the study. Based on observed results for each trial, the recommendation of the multinomial stopping rule was applied, as was the recommendation of the actual stopping rule used (Fleming or Gehan). The appropriateness of the recommendations was evaluated based on interpretation of final study results. RESULTS: The standard and multinomial rules disagreed on early stopping in one of 16 NCIC CTG trials and in seven of 23 ECSG trials. In all cases, the standard rule advised continuing to the second stage whereas the multinomial rule advised stopping early because of excessive numbers of patients experiencing early disease progression. Final trial results indicated that the multinomial recommendation was appropriate, because in no study did final results lead to conclusions of activity. CONCLUSION: In this series of trials, the multinomial stopping rule performed more efficiently than the Fleming or Gehan rules in advising early stopping of trials. These results encourage continued exploration of this approach for phase II trials of cytotoxic and noncytotoxic anticancer agents.

Clinical Trials, Phase II as Topic↗
PubMed2001

A review of dose-limiting events in phase I trials: antimetabolites show unpredictable relationships between dose and toxicity.

INTRODUCTION: In a sample of NCIC CTG phase I trials we noted that studies of antimetabolites were frequently confounded by the occurrence of dose-limiting toxicities (DLT) at doses well below those ultimately recommended (recommended dose, RD) for further study, necessitating frequent expansion of dose levels and usually a change to more conservative dose escalation. This slowed development, exposed patients to ineffective doses of drugs, and raises concerns about the safety of current trial designs which include a single patient per dose level. Conversely, some patients treated at the RD may be receiving inadequate doses of anticancer drugs. To determine if this was a general phenomenon, we undertook a review of the results of a large group of phase I trials of cytotoxic agents. METHODS: Starting dose (SD), number of dose levels, dose at first DLT (D-DLT), maximum tolerated doses (MTD, dose at which DLT is seen in two or more patients) and RD were extracted from the NCI-Canada phase I trial database, and from a literature survey of phase I studies published between 1985 and 1999. Combination phase I and phase Ib studies were excluded. RESULTS: The review included 33 trials with antimetabolites and 60 with other cytotoxic agents. The median ratio D-DLT/MTD was 0.33 for antimetabolites and 0.75 for other cytotoxic agents (P < 0.01). Similarly, the median ratio D-DLT/RD was 0.43 for antimetabolites and 1 for other cytotoxic agents (P < 0.01). The median number of dose levels tested was nine for antimetabolites and six for other cytotoxic agents. DISCUSSION: Statistically significant differences in the ratios D-DLT/MTD and D-DLT/RD between antimetabolites and other cytotoxic compounds were noted, confirming our initial observations that unpredictable DLT occurs earlier and at lower dose levels in phase I clinical trials of antimetabolites than would be expected as compared to other classes ofcytotoxic agents. Toxicity thus appears to be incompletely predicted by dose alone for antimetabolites. DLT may occur in certain patients at doses well below the RD. Current phase I design may not be ideal for development of these compounds, and should focus on pharmacodynamic endpoints in addition to traditional pharmacokinetic and clinical endpoints.

Antimetabolites, Antineoplastic↗
PubMed2001

Impact of new non-cytotoxics in the treatment of ovarian cancer.

Over the last decade, a number of new cytotoxic chemotherapy agents have shown evidence of antitumor activity in patients with ovarian carcinoma. These agents are currently being evaluated in large multinational randomized trials to determine whether their addition either concurrently or sequentially to standard paclitaxel and carboplatin regimens will result in improved survival. Whether these new combinations will provide additional benefit may be uncertain; however, it is certain that additional toxicity will limit the continued evaluation of the strategy of adding cytotoxics together. New approaches to improve the systemic therapy of ovarian cancer need to be explored. The next decade will see many trials of non-cytotoxics having a wide range of subcellular and extracellular targets. Many of these targets are abnormally expressed in a variety of solid tumors; thus, it is expected that many of these agents will be appropriate to evaluate in patients with ovarian carcinoma. Based on promising data from preclinical and early clinical studies as well as the presumed applicability of these targets to ovarian carcinoma, the inhibitors of growth factor receptors such as epidermal growth factor receptor and inhibitors of angiogenesis are of particular interest. Despite the interest of the investigators, the rapid evaluation of these target-specific non-cytotoxics is limited by the lack of accurate information on the expression of target in ovarian tumors and the relevance of target expression and its modulation to this tumor type. Early clinical trials are being designed to address these concerns; however, the clinical impact of non-cytotoxic agents in epithelial ovarian carcinoma patients must await the completion of randomized evaluations in combination with standard chemotherapeutic regimens.

Angiogenesis Inhibitors↗
PubMed2000

Phase II feasibility study of sequential couplets of Cisplatin/Topotecan followed by paclitaxel/cisplatin as primary treatment for advanced epithelial ovarian cancer: a National Cancer Institute of Canada Clinical Trials Group Study.

PURPOSE: Despite the improved results in advanced ovarian cancer achieved with the addition of paclitaxel to frontline therapy, there remains room for improvement. One approach is to add new agents such as topotecan. Because myelosuppression limits the delivery of topotecan with paclitaxel/cisplatin in a three-drug combination, we explored giving sequential couplets of cisplatin/topotecan followed by paclitaxel/cisplatin. PATIENTS AND METHODS: Forty-four patients with residual epithelial ovarian carcinoma after primary surgery were studied. Cisplatin 50 mg/m(2) on day 1 and topotecan 0.75 mg/m(2) on days 1 through 5 were administered at 21-day intervals for four cycles, followed by interval debulking surgery (if optimal debulking was not achieved with primary surgery), and then paclitaxel 135 mg/m(2) over 24 hours on day 1 and cisplatin 75 mg/m(2) on day 2 at 21-day intervals for four cycles. RESULTS: Such sequential couplets are feasible. Myelotoxicity was the major toxic effect, but it was of short duration. The granulocyte nadir with topotecan/cisplatin occurred late (median, day 18), so retreatment on day 21 was not always possible. There was no unexpected nonhematologic toxicity. The regimen was active in this group of patients who had undergone largely suboptimal debulking surgery. In 34 patients with clinically measurable disease, the overall response rate was 78%, and 30 (77%) of the 39 patients with elevated CA 125 levels at baseline had normalization of CA 125 levels by the end of therapy. CONCLUSION: Sequential couplets of cisplatin/topotecan followed by paclitaxel/cisplatin are feasible. The efficacy data in this suboptimal group of patients has encouraged us to proceed with a randomized study based on this approach.

Adult↗
PubMed2000

Phase I dose-finding study of a new taxane, RPR 109881A, administered as a one-hour intravenous infusion days 1 and 8 to patients with advanced solid tumors.

PURPOSE: To define the maximum-tolerated dose, recommended phase II dose (RD), dose-limiting toxicity (DLT), and pharmacokinetics of a novel taxane, RPR 109881A, administered on days 1 and 8 of a 21-day cycle. PATIENTS AND METHODS: Twenty-nine patients were enrolled and treated according to a modified continual reassessment method from a starting dose of 7.5 mg/m(2) to 52.5 mg/m(2). Detailed pharmacokinetic analyses of blood and urine were performed on days 1 and 8 of the first cycle. Toxicity was monitored weekly. RESULTS: DLT consisting of grade 3 or 4 diarrhea was seen in three of six patients at 52.5 mg/m(2). Grade 3 or 4 granulocytopenia was also seen in five of six patients treated at this dose (four of six in the first cycle). At the next lower dose level, 45 mg/m(2) toxicity was moderate, with only one of 12 patients experiencing severe diarrhea and grade 4 granulocytopenia with associated infection. Drug concentrations were consistent with a three-compartment open model. The total-body clearance suggests a linear dose-concentration relationship. RPR 109881A has a high clearance (mean, 42.6 L/h/m(2)), a large volume of distribution (mean, 952 L/m(2)), and a long terminal half-life (mean, 24 hours). There was no drug accumulation between days 1 and 8. One partial response was seen in a patient with renal cell carcinoma. CONCLUSION: The RD of RPR 109881A given as a 1-hour infusion on days 1 and 8 of a 21-day cycle is 45 mg/m(2). At this dose the drug is well tolerated and should be further studied.

Adult↗
PubMed2000

Long-term follow-up of remission duration, mortality, and second malignancies in hairy cell leukemia patients treated with pentostatin.

The nucleoside analogue, pentostatin, has demonstrated high complete response rates and long relapse-free survival times in patients with hairy cell leukemia, a disease that historically had been unresponsive to treatment. Long-term data on duration of overall survival and relapse-free survival and incidence of subsequent malignancies with this agent are lacking. Patients completing the treatment phase of a randomized, intergroup study who received pentostatin as an initial treatment or who crossed over after failure of interferon alpha were followed for survival, relapse, and diagnosis of subsequent malignancies. Two hundred forty-one patients treated with pentostatin as initial therapy (n = 154) or who crossed over after failure of interferon alpha (n = 87) were followed for a median duration of 9.3 years. Estimated 5- and 10-year survival rates (95% confidence interval) for all patients combined were 90% (87%-94%) and 81% (75%-86%), respectively. In the 173 patients with a confirmed complete response to pentostatin treatment, 5- and 10-year relapse-free survival rates were 85% (80%-91%) and 67% (58%-76%), respectively. Survival curves for patients initially treated with pentostatin and those crossed over were similar. Only 2 of 40 deaths were attributed to hairy cell leukemia. The mortality rate and incidence of subsequent malignancies were not higher than expected in the general population. Pentostatin is a highly effective regimen for hairy cell leukemia that produces durable complete responses. Subsequent malignancies do not appear to be increased with pentostatin treatment.

Adult↗
PubMed2000

A phase I-II study of 9-cis retinoic acid and interferon-alpha2b in patients with advanced renal-cell carcinoma: an NCIC Clinical Trials Group study.

Although advanced renal-cell carcinoma (RCC) responds poorly to standard therapies, phase I-II trials have shown activity for combinations of interferon-alpha2b (IFN) with a retinoid. Alitretinoin (9-cis RA) is an endogenous retinoid with high binding affinity for both RAR and RXR receptor families. This phase I-II study enrolled 38 patients with RCC in a dose-escalation study of tolerability, pharmacokinetics (PK), and efficacy of twice daily oral 9-cis RA with subcutaneous IFN. In contrast to studies with similar doses of daily 9-cis RA, PK studies found a consistent reduction in 9-cis RA concentrations of about 50% after multiple b.i.d. doses of 30 or 50 mg/m2, independent of cotreatment with IFN. In the phase I portion, toxicities included systemic symptoms typical of IFN and biochemical abnormalities previously associated with retinoids. Two patients experienced dose-limiting toxicity at 50 mg/m2 b.i.d. of 9-cis RA, thus the recommended phase II dose was 30 mg/m2 b.i.d. One of twenty-six evaluable patients achieved a durable objective partial remission, and repeated dosing with this regimen was poorly tolerated. This combination of retinoid and interferon is not recommended for further study in RCC.

Adult↗