Liposomal-entrapped doxorubicin: an active agent in AIDS-related Kaposi's sarcoma.

1995 ◽  
Vol 13 (4) ◽  
pp. 914-920 ◽  
Author(s):  
M Harrison ◽  
D Tomlinson ◽  
S Stewart
Keyword(s):  
Kaposi's Sarcoma ◽  
Response Rate ◽  
Single Agent ◽  
Locally Advanced ◽  
Active Agent ◽  
Kaposi’S Sarcoma ◽  
World Health ◽  
Outpatient Basis ◽  
Karnofsky Score ◽  
Highly Active

PURPOSE A phase II study was performed of single-agent liposomally entrapped doxorubicin ([LED] Doxil; Liposome Technology Inc, Menlo Park, CA) against locally advanced cutaneous/systemic AIDS-related Kaposi's sarcoma (KS). PATIENTS AND METHODS Thirty-four patients with AIDS-related advanced cutaneous/systemic KS were treated with 20 mg/m2 of LED every 3 weeks on an outpatient basis. The median age was 39 years and the median Karnofsky score was 70. All patients had poor prognostic disease as judged by AIDS Clinical Trials Group (ACTG) criteria. Nineteen of 34 patients had received prior chemotherapy for KS, although no patient had received prior anthracyclines. RESULTS An overall response rate of 73.5% (25 of 34) was observed. Partial responses (PRs) occurred in 67.7% (23 of 34) and complete responses (CRs) in 5.8% (two of 34). In patients who had received previous chemotherapy, the response rate was 68.4% (13 of 19), and all responses were PRs. The median time to response was 6 weeks. The median duration of response was 9 weeks. Toxicity according to World Health Organization (WHO) criteria was as follows: neutropenia (grade > or = 3), 34%; alopecia (grade 1 only), 9%; and nausea and vomiting (grade 1), 18%. One patient died of heart failure, which was not considered to be anthracycline-induced. CONCLUSION LED appears to be highly active against AIDS-related KS. The major toxicity is neutropenia, which seems to be progressive in patients who receive several cycles of therapy. Comparative studies of LED versus conventional chemotherapy are needed.

Phase II trial of vinorelbine in metastatic squamous cell esophageal carcinoma. European Organization for Research and Treatment of Cancer Gastrointestinal Treat Cancer Cooperative Group.

1996 ◽  
Vol 14 (1) ◽  
pp. 164-170 ◽  
Author(s):  
T Conroy ◽  
P L Etienne ◽  
A Adenis ◽  
D J Wagener ◽  
B Paillot ◽  
...  
Keyword(s):  
Esophageal Carcinoma ◽  
Squamous Cell ◽  
Response Rate ◽  
Single Agent ◽  
Active Agent ◽  
Dose Intensity ◽  
World Health ◽  
Who Grade ◽  
European Organization ◽  
Prior Chemotherapy

PURPOSE To evaluate the response rate and toxic effects of vinorelbine (VNB) administered as a single agent in metastatic squamous cell esophageal carcinoma. PATIENTS AND METHODS Forty-six eligible patients with measurable lesions were included and were stratified according to previous chemotherapy. Thirty patients without prior chemotherapy and 16 pretreated with cisplatin-based chemotherapy were assessable for toxicity and response. VNB was administered weekly as a 25-mg/m2 short intravenous (i.v.) infusion. RESULTS Six of 30 patients (20%) without prior chemotherapy achieved a partial response (PR) (95% confidence interval [CI], 8% to 39%). The median duration of response was 21 weeks (range, 17 to 28). One of 16 patients (6%) with prior chemotherapy had a complete response (CR) of 31 weeks' duration (95% CI, 0% to 30%). The overall response rate (World Health Organization [WHO] criteria) was 15% (CR, 2%; PR 13%; 95% CI, 6% to 29%). The median dose-intensity (DI) was 20 mg/m2/wk. VNB was well tolerated and zero instances of WHO grade 4 nonhematologic toxicity occurred. At least one episode of grade 3 or 4 granulocytopenia was seen in 59% of patients. A grade 2 or 3 infection occurred in 16% of patients, but no toxic deaths occurred. Other side effects were rare, and peripheral neurotoxicity has been minor (26% grade 1). CONCLUSION These data indicate that VNB is an active agent in metastatic esophageal squamous cell carcinoma. Given its excellent tolerance profile and low toxicity, further evaluation of VNB in combination therapy is warranted.

Gemcitabine Is An Active Agent in the Treatment of T Cell Non Hodgkin Lymphomas.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 4771-4771
Author(s):  
Ahmad Jajeh
Keyword(s):  
T Cell ◽  
Response Rate ◽  
Cell Lymphoma ◽  
Dose Range ◽  
Single Agent ◽  
Active Agent ◽  
T Cell Lymphoma ◽  
World Health ◽  
High Dose ◽  
Cell Transplant

Abstract Abstract 4771 Approximately 12- 15% of non- Hodgkin lynphoma NHL are caused by malignant Tcell lymphocytes. The success of the treatment in the aggressive form has lagged behind that of B -Cell in term of poor resonse and durability. Peripheral T-Cell lymphoma PTCL and cutaneous T-Cell lymphoma CTCL are two major charachterized classifiction in the World Health Organization based on their morphology, growth patern and genetics. Stem cell transplant and high dose chemotherapy have been associated with long term response rate of 45%. However this treatment is not well tolerated and not feasible for many patients. Other theraputic options include cytotoxic drugs CHOP,CVP regimen, purine analogues, Denileukin diftitox, Histone deacetylation inhibitors and novel antifolates drugs. In this abstract we will show our experience with gemcitabin an active antimetabolite as a single agent or in combination with other active drugs. Eight patients with PTCL, five with visceral stage of mycosis fundoides( one patient with HIV infection), two with refractory anaplastic Ki positive NHL and one with angioimmunoblastic type. All patients failed a minimum two lines of therapy. Mean age 58 years( range 28-75). Eight blacks, two whites, four hispanics and one asian. Meduim cycles given are four. The dose range 800-1000 mg/M2, given weekly x3 every 28 days cycle. Overall response rate is 85%. Complete response rate CR in eight patients ( three PTCL, three mycosis fungoides and two anaplastic large cell NHL). Partial response PR in four and stable disease in one. Median duration of response is nine months, range six to two years. Median time for response is six weeks. In conclusion:Gemcitabine is an active drug in T-Cell lymphomas particularly when used in combination with other active agents. Maintenance dosing or retreatment with this drug should be investigated. Disclosures: No relevant conflicts of interest to declare.

Treatment of acquired immunodeficiency syndrome--related Kaposi's sarcoma with lymphoblastoid interferon.

1985 ◽  
Vol 3 (4) ◽  
pp. 506-512 ◽  
Author(s):  
A Rios ◽  
P W Mansell ◽  
G R Newell ◽  
J M Reuben ◽  
E M Hersh ◽  
...  
Keyword(s):  
Complete Remission ◽  
Kaposi's Sarcoma ◽  
Response Rate ◽  
Performance Status ◽  
Active Agent ◽  
Kaposi’S Sarcoma ◽  
Hematologic Toxicity ◽  
Median Response ◽  
Number Of Patients ◽  
Lymphoblastoid Interferon

Twelve homosexual patients with Kaposi's sarcoma associated with the acquired immune deficiency syndrome (AIDS) were treated with a preparation of purified human lymphoblastoid interferon (Wellferon [Burroughs Wellcome, Research Triangle Park, NC]). They were given a dose of 20 X 10(6) U/m2 intramuscularly daily for approximately two months. Responders continued their treatment on a maintenance schedule of 20 X 10(6) U/m2 three times a week. Four patients experienced complete remissions, and four experienced partial remissions that resulted in a total response rate of 67%. The median duration of treatment was 14 weeks (7 to 28+ weeks), and the median response duration was 28+ weeks (19 to 29+ weeks). Of the four patients in complete remission, one relapsed at 25 weeks and one at 26 weeks; the other two remained in complete remission at 28 and 29+ weeks. The clinical toxicity consisted of chills, fever, fatigue, and asthenia. Hematologic toxicity was similar to that previously described for other preparations of alpha-interferon and consisted of moderate leukopenia and thrombocytopenia. Asthenia, a condition present in all 12 patients, was severe in 50%. A minimal tumor burden, the absence of circulating interferon before treatment, and a performance status of greater than or equal to 90% on the Karnofsky scale were related to an improved response rate. Measurement of immunologic parameters showed significant declines in the already impaired T cell levels, lymphocyte blastogenic response to concanavalin A, monocyte-mediated antibody-dependent cellular cytotoxicity, and monocyte-adherence. Activation of natural killer cells was not noted, and no life-threatening infections occurred during treatment. These data suggest that human lymphoblastoid interferon is an active agent in the treatment of Kaposi's sarcoma, and its use warrants further study in a larger number of patients.

Angiogenesis Inhibitor IM862 Is Ineffective Against AIDS-Kaposi's Sarcoma in a Phase III Trial, but Demonstrates Sustained, Potent Effect of Highly Active Antiretroviral Therapy: From the AIDS Malignancy Consortium and IM862 Study Team

2005 ◽  
Vol 23 (5) ◽  
pp. 990-998 ◽  
Author(s):  
Ariela Noy ◽  
David T. Scadden ◽  
Jeannette Lee ◽  
Bruce J. Dezube ◽  
David Aboulafia ◽  
...  
Keyword(s):  
Antiretroviral Therapy ◽  
Phase I ◽  
Highly Active Antiretroviral Therapy ◽  
Kaposi's Sarcoma ◽  
Response Rate ◽  
Kaposi’S Sarcoma ◽  
Phase Iii ◽  
Time To Progression ◽  
Phase Iii Trial ◽  
Highly Active

PurposeIM862 is a synthetic dipeptide (l-glutamine l-tryptophan) with in vitro and in vivo antiangiogenic properties. Phase I/II studies showed minimal toxicity and a response rate of 36% in AIDS-Kaposi's sarcoma. We report a 24-week, randomized, double-blinded, placebo-controlled phase III trial with the phase II dose, 5 mg intranasally every other day.Patients and MethodsTwo hundred two HIV-positive patients were enrolled, 104 on IM862 and 98 on placebo.ResultsBaseline characteristics were comparable except current antiretroviral therapy: 88% versus 96% (IM862 v placebo group; P = .042). The median treatment durations were 19.5 versus 24 weeks (IM862 v placebo). No significant difference was detected in response rate (IM862, 23%; 95% CI, 15% to 32% v placebo, 21%; 95% CI, 14% to 31%; P = .46), time to response (8.5 weeks v 14 weeks; P = .024), or duration of response. However, IM862 was associated with both a shorter time to response (8.5 weeks v 14 weeks; P = .024) and shorter median time to progression (16 weeks, 95% CI, 13 to 27 weeks v 35 weeks, 95% CI, 26 to 114 weeks; P = .012).ConclusionDespite promising phase I and phase II studies, IM862 5 mg every other day was not superior to placebo and may accelerate time to progression. Highly active antiretroviral therapy alone was associated with a substantial rate of sustained tumor response and may have contributed to prior estimates of IM862 response. Therapeutic trials for AIDS-Kaposi's sarcoma must account for ongoing immune reconstitution in the setting of concurrent highly active antiretroviral therapy that may confound estimates of therapeutic activity.

scholarly journals Transplant-associated penile Kaposi sarcoma managed with single agent paclitaxel chemotherapy: a case report

BMC Urology ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Matthew A. Anderson ◽  
Tracey Ying ◽  
Kate Wyburn ◽  
Peter M. Ferguson ◽  
Madeleine C. Strach ◽  
...  
Keyword(s):  
Kaposi's Sarcoma ◽  
Single Agent ◽  
Lower Extremities ◽  
Kaposi’S Sarcoma ◽  
The Body ◽  
Cutaneous Lesions ◽  
Rare Presentation ◽  
Post Transplant ◽  
Transplant Patients ◽  
Disseminated Disease

Abstract Background Kaposi’s sarcoma is an uncommon complication in renal transplant patients, and typically presents with cutaneous lesions on the lower extremities. Penile involvement has been reported only rarely. Management of cutaneous-limited disease is primarily reduction of immunosuppression and conversion to an mTOR-inhibitor, whereas the treatment of disseminated disease in transplant patients is more variable. Case presentation A 75-year-old male, originally from Somalia, received a deceased-donor kidney transplant for diabetic and hypertensive nephropathy. Seven months post-transplant he presented with lower limb lesions, oedema and bilateral deep vein thromboses. He then developed a fast-growing painful lesion on his penile shaft. A biopsy of this lesion confirmed KS, and a PET scan demonstrated disseminated disease in the lower extremities, penis and thoracic lymph nodes. His tacrolimus was converted to sirolimus, and his other immunosuppression was reduced. He was treated with single agent paclitaxel chemotherapy in view of his rapidly progressing, widespread disease. The penile lesion completely resolved, and the lower extremity lesions regressed significantly. His kidney allograft function remained stable throughout treatment. Conclusion This case illustrates a rare presentation of an uncommon post-transplant complication and highlights the need for a high index of suspicion of KS in transplant patients presenting with atypical cutaneous lesions. It serves to demonstrate that the use of single agent paclitaxel chemotherapy, switch to an mTORi and reduction in immunosuppression where possible produces excellent short-term outcomes, adding to the body of evidence for this management strategy in disseminated Kaposi’s sarcoma.

Phase I study of the combination of fludarabine, mitoxantrone, and dexamethasone in low-grade lymphoma.

1994 ◽  
Vol 12 (3) ◽  
pp. 575-579 ◽  
Author(s):  
P McLaughlin ◽  
F B Hagemeister ◽  
F Swan ◽  
F Cabanillas ◽  
O Pate ◽  
...  
Keyword(s):  
Overall Response Rate ◽  
Response Rate ◽  
Single Agent ◽  
Active Agent ◽  
Large Cell ◽  
Maximum Tolerated Dose ◽  
Low Grade ◽  
Overall Response ◽  
Nonhematologic Toxicity ◽  
High Fraction

PURPOSE Fludarabine is an active agent for patients with low-grade lymphoma (LGL) but has mainly been used as a single agent. This trial was designed to define the maximum-tolerated dose (MTD) of a combination of fludarabine, mitoxantrone, and dexamethasone (FND), to identify the toxicities of these agents in combination, and to make preliminary observations about the efficacy of this combination. PATIENTS AND METHODS Twenty-one patients with recurrent LGL or follicular large-cell lymphoma were treated, in cohorts of three, at stepwise escalating doses. Patients were required to have adequate marrow function and normal renal, hepatic, and cardiac function. RESULTS The MTD of the combination was found to be as follows: fludarabine, 25 mg/m2/d (days 1 to 3); mitoxantrone, 10 mg/m2 (day 1); and dexamethasone, 20 mg/d (days 1 to 5). Each course was administered monthly, and up to eight courses were given. Dose-limiting toxicities were neutropenia and infections. Thrombocytopenia was modest. Nonhematologic toxicity was very modest. Responses were seen at every dose level. The overall response rate was 71%, with a 43% complete remission (CR) rate. The median duration of CR was 18 months (with follow-up duration from 13 to 28+ months). CONCLUSION FND was well tolerated in this population. While our primary aim was to define the MTD, our preliminary observations on the efficacy of the regimen were favorable. The overall response rate was high, there was a high fraction of CRs, and our early impression is that these responses are durable.

A comparison of carboplatin plus methotrexate versus methotrexate alone in patients with recurrent and metastatic head and neck cancer.

1989 ◽  
Vol 7 (9) ◽  
pp. 1341-1345 ◽  
Author(s):  
M Eisenberger ◽  
S Krasnow ◽  
S Ellenberg ◽  
H Silva ◽  
J Abrams ◽  
...  
Keyword(s):  
Head And Neck ◽  
Ethical Issues ◽  
Response Rate ◽  
Performance Status ◽  
Single Agent ◽  
Active Agent ◽  
Dose Schedule ◽  
Substantial Improvement ◽  
Two Stage ◽  
Study Objective

Patients with recurrent and metastatic squamous cell carcinoma of the head and neck (SCCHN) were stratified by performance status, extent of disease, and prior radiotherapy and subsequently randomized to receive carboplatin (CBDCA; Bristol-Myers, Wallingford, CT) administered intravenously (IV) monthly, initially at doses of 400 mg/m2 in combination with methotrexate (MTX) given IV weekly at doses of 40 mg/m2 or MTX alone at the same dose/schedule. Significant dose-limiting myelosuppression required CBDCA dose reductions to 300 mg/m2 and, subsequently, 200 mg/m2. Nonhematological toxicities were not significant. Our study objective was to determine whether CBDCA plus MTX produce a substantial improvement in response rate over single-agent MTX. A response rate of 50% (complete [CR] plus partial response [PR]) for CBDCA plus MTX compared with 25% for MTX was specified as the difference to be detected. We employed a two-stage study design for randomized trials that allowed for early termination of studies involving relatively ineffective treatment regimens. With this design, the study could be closed after the first stage (20 patients entered onto each treatment arm) if the number of responders to CBDCA plus MTX were not superior to MTX. Five of 20 patients responded to treatment in each arm, and we were able to conclude that the addition of CBDCA to MTX is unlikely to result in a twofold increase in response rate compared with MTX alone in this group of patients. This two-stage design represents a simple and efficient method of testing the relative efficacy of new combinations containing at least one active agent against a suitable control arm in this disease. It addresses scientific and ethical issues of continuing testing with relatively ineffective treatments, and at the same time provides a reliable method for identifying very active regimens likely to represent significant therapeutic advances.

Phase II trial with dose titration of paclitaxel for the therapy of human immunodeficiency virus-associated Kaposi's sarcoma.

1998 ◽  
Vol 16 (3) ◽  
pp. 1112-1121 ◽  
Author(s):  
L Welles ◽  
M W Saville ◽  
J Lietzau ◽  
J M Pluda ◽  
K M Wyvill ◽  
...  
Keyword(s):  
Human Immunodeficiency Virus ◽  
Kaposi's Sarcoma ◽  
Single Agent ◽  
Kaposi’S Sarcoma ◽  
Complete Response ◽  
Pulmonary Involvement ◽  
Dose Titration ◽  
Treatment Schedule ◽  
Creatinine Concentration ◽  
Immunodeficiency Virus

PURPOSE To investigate the antitumor activity and safety of paclitaxel in patients with advanced human immunodeficiency virus (HIV)-associated Kaposi's sarcoma (KS). PATIENTS AND METHODS Twenty-nine patients with advanced HIV-associated KS were enrolled. The patients were overall quite immunosuppressed (median CD4 count, 15 cells/microL). Paclitaxel was initially administered at 135 mg/m2 over 3 hours every 3 weeks without filgrastim support; the dose was increased as tolerated to a maximum of 175 mg/m2. Patients who failed to respond or progressed could then receive filgrastim support or paclitaxel administered over 96 hours. RESULTS Of 28 assessable patients, 20 had major responses (18 partial responses [PRs], one clinical complete response [CR], and one CR), for a major response rate of 71.4% (95% confidence interval [CI], 51.3% to 86.8%). Each of the five patients with pulmonary KS responded, as did all four assessable patients who had previously received anthracycline therapy for KS. Of six patients who went on to receive a 96-hour infusion of paclitaxel, five had major responses. Neutropenia was the most frequent dose-limiting toxicity; possible novel toxicities included late fevers, late rash, and eosinophilia. Two patients developed an elevated creatinine concentration and one cardiomyopathy. CONCLUSION Paclitaxel has substantial activity against advanced HIV-associated KS as a single agent, even in patients with pulmonary involvement or who had previously received anthracyclines. Further research is needed to define the optimal treatment schedule and its role vis-a-vis the other available therapies for this disease.

Paclitaxel Is Safe and Effective in the Treatment of Advanced AIDS-Related Kaposi's Sarcoma

1999 ◽  
Vol 17 (6) ◽  
pp. 1876-1876 ◽  
Author(s):  
Parkash S. Gill ◽  
Anil Tulpule ◽  
Byron M. Espina ◽  
Suzanne Cabriales ◽  
Jocelyn Bresnahan ◽  
...  
Keyword(s):  
Treatment Failure ◽  
Median Duration ◽  
Systemic Therapy ◽  
Kaposi's Sarcoma ◽  
Single Agent ◽  
Kaposi’S Sarcoma ◽  
Duration Of Response ◽  
Previously Treated ◽  
Prior Systemic Therapy ◽  
Grade 3

PURPOSE: Liposomal anthracyclines are the present standard treatment for advanced AIDS-related Kaposi's sarcoma (KS). No effective therapies have been defined for use after treatment failure of these agents. A phase II trial was thus conducted with paclitaxel in patients with advanced KS to assess safety and antitumor activity. MATERIALS AND METHODS: A regimen of paclitaxel at a dose of 100 mg/m2 was given every 2 weeks to patients with advanced AIDS-related KS. Patients were treated until complete remission, disease progression, or unacceptable toxicity occurred. RESULTS: Fifty-six patients with advanced AIDS-related KS were accrued. Tumor-associated edema was present in 70% of patients and visceral involvement in 45%. Forty patients (71%) had received prior systemic therapy; 31 of these were resistant to an anthracycline. The median entry CD4+ lymphocyte count was 20 cells/mm3 (range, 0 to 358). A median of 10 cycles (range, 1 to 54+) of paclitaxel was administered. Fifty-nine percent of patients showed complete (n = 1) or partial response (n = 32) to paclitaxel. The median duration of response was 10.4 months (range, 2.8 to 26.7+ months) and the median survival was 15.4 months. The main side effects of therapy were grade 3 or 4 neutropenia in 61% of patients and mild-to-moderate alopecia in 87%. CONCLUSION: Paclitaxel at 100 mg/m2 given every 2 weeks is active and well tolerated in the treatment of advanced and previously treated AIDS-related KS. The median duration of response is among the longest observed for any regimen or single agent reported for AIDS-related KS. Paclitaxel at this dosage and schedule is a treatment option for patients with advanced AIDS-related KS, including those who have experienced treatment failure of prior systemic therapy.

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