A phase II study of dibromodulcitol (DBD) in Stage IV melanoma

1984 ◽  
Vol 7 (5) ◽  
pp. 555-556
Author(s):  
Judy Hopkins ◽  
Frederick Richards ◽  
Douglas Case ◽  
Ellen Pope ◽  
Don V. Jackson ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Study ◽  
Stage Iv ◽  
Stage Iv Melanoma

Phase II study of aflibercept (VEGF trap) in recurrent inoperable stage III or stage IV melanoma of cutaneous or ocular origin

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 9028-9028
Author(s):  
A. A. Tarhini ◽  
S. Christensen ◽  
P. Frankel ◽  
K. Margolin ◽  
C. Ruel ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Study ◽  
Angiogenesis Inhibitor ◽  
Stage Iv ◽  
Left Ventricular Diastolic Dysfunction ◽  
Left Ventricular ◽  
Stage Iii ◽  
Unknown Primary ◽  
Vegf Receptor ◽  
Stage Iv Melanoma

9028 Background: Aflibercept is a fusion protein combining the Fc portion of human IgG1with the extracellular ligand-binding domains of human VEGFR1 and VEGFR2, acting as a high-affinity soluble VEGF receptor and potent angiogenesis inhibitor. Methods: Phase II study of aflibercept in patients with inoperable stage III or IV melanoma who had received no prior chemotherapy or hormonal therapy. A 2-stage design was adopted focusing upon response rate (RECIST) and 4-month PFS rate. First stage accrual of 21 patients was specified, while final accrual of 41 is planned, with adequate response/4 month PFSR. Aflibercept was given at 4 mg/kg IV every 2 weeks. Response was assessed every 8 weeks. Results: Twenty seven patients (16 male, 11 female), age 23–83 (median 58) have been enrolled to date. All had AJCC stage IV melanoma (3M1a, 3M1b, 21M1c). Karnofsky PS: 100 (13), 90 (11) or 80 (3). Nine patients had primary ocular melanoma, 16 cutaneous and 2 unknown primary site. A total of 160 cycles have been administered (median 4; range 1–18). Grade 3/4 toxicities included cerebral ischemia (1 patient; 4%), confusion (1; 4%), thrombocytopenia (1; 4%), hypertension (7; 26%), hypotension (1; 4%), left ventricular diastolic dysfunction (1; 4%), fatigue (1; 4%), proteinuria (4; 15%), extraocular muscle paresis (1; 4%), renal failure (1; 4%), back pain (1; 4%), headache (1; 4%). Interim analysis was conducted after the first 21 patients (stage 1). Eight (1 M1a, 1M1b, 6M1c; 4 ocular, 3 cutaneous, 1 unknown primary) of the first 21 patients had at least 4 months of PFS (10 out of 27; 2 additional patients with cutaneous melanoma had SD: 1M1a and 1M1c). One patient (23rd; cutaneous, M1c) had a confirmed complete remission. Four patients were taken off study prior to response evaluation for toxicity (3) or treatment refusal (1). One patient is currently disease free who was not evaluable for response (previous surgery and radiofrequency ablation of measurable disease site). Eleven patients had progression. Conclusions: Aflibercept can be administered with acceptable toxicity, and exhibits promising antitumor efficacy against advanced melanoma. This study continues second stage accrual with anticipated closure before June 2009. [Table: see text]

Combined treatment with ipilimumab and intratumoral interleukin-2 in pretreated patients with stage IV melanoma—safety and efficacy in a phase II study

2016 ◽  
Vol 66 (4) ◽  
pp. 441-449 ◽  
Author(s):  
Benjamin Weide ◽  
Alexander Martens ◽  
Kilian Wistuba-Hamprecht ◽  
Henning Zelba ◽  
Ludwig Maier ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Study ◽  
Combined Treatment ◽  
Interleukin 2 ◽  
Stage Iv ◽  
Safety And Efficacy ◽  
Pretreated Patients ◽  
Stage Iv Melanoma

scholarly journals Randomized Phase II Study of IL-2 With or Without an Allogeneic Large Multivalent Immunogen Vaccine for the Treatment of Stage IV Melanoma

2014 ◽  
Vol 37 (3) ◽  
pp. 261-265 ◽  
Author(s):  
Gautam Jha ◽  
Jeffrey S. Miller ◽  
Julie M. Curtsinger ◽  
Yan Zhang ◽  
Mathew F. Mescher ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Study ◽  
Stage Iv ◽  
Randomized Phase Ii ◽  
Stage Iv Melanoma

Phase II study of docetaxel and vinorelbine plus GM-CSF in malignant melanoma

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 18017-18017
Author(s):  
J. P. Fruehauf ◽  
K. M. Kong ◽  
J. G. Jakowatz
Keyword(s):  
Phase Ii ◽  
Phase Ii Study ◽  
Stage Iv ◽  
Synergistic Activity ◽  
Time To Progression ◽  
Proc Asco ◽  
Lung Cancer Patients ◽  
Gm Csf ◽  
Melanoma Patients ◽  
Stage Iv Melanoma

18017 Background: Patients having locoregional or metastatic melanoma have a poor prognosis, with 50% to 10% of patients dying from the disease within 5 years. Current chemotherapy regimens offer limited benefits to these patients and more effective and less toxic treatments are needed. Methods: We developed a phase II clinical trial to evaluate the activity of an every two week schedule of docetaxel (40mg/m2, d1), vinorelbine (30 mg/m2, d1) IV and sargramostim (GMCSF, 250 ug/m2 sq d2–11). This regimen was developed based on preclinical synergistic activity of paclitaxel plus vinorelbine (Neale et al. Melanoma Res 11:601, 2001), and evidence that the docetaxel plus vinorelbine combination can be given safely to lung cancer patients (Sanchez et al. Lung Ca 38:309, 2002). Sargramostim was included based on preliminary clinical data that it delays time to progression in stage IV melanoma patients resected for cure (Spitler, JCO 18:1614, 2000). We report here an interim analysis for the initial 21 patients with stage IV melanoma treated in first or second line. Results: The primary endpoint was time to progression. Grade III/IV toxicities included anemia (12.5%) and neutropenia (5%), with one patient requiring 25% dose reduction. To date, median time to progression (TTP) is 7 months, with 30% of cases showing greater than 8 months TTP. Conclusions: This result compares favorably with biochemotherapy, which has a median TTP of 5 months and overall survival of 8.4 months (Atkins Proc ASCO 22:708. 2003), while being significantly less toxic. Based on these favorable findings, we are continuing to accrue patients to this trial. [Table: see text]

A phase II study of biochemotherapy in stage IV melanoma

1997 ◽  
Vol 7 (Supplement 1) ◽  
pp. S113
Author(s):  
R Gonzalez ◽  
W Lee ◽  
L Dreiling ◽  
M Becker ◽  
J Ferguson ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Study ◽  
Stage Iv ◽  
Stage Iv Melanoma

scholarly journals A randomised, phase II study of intetumumab, an anti-αv-integrin mAb, alone and with dacarbazine in stage IV melanoma

2011 ◽  
Vol 105 (3) ◽  
pp. 346-352 ◽  
Author(s):  
S O'Day ◽  
◽  
A Pavlick ◽  
C Loquai ◽  
D Lawson ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Study ◽  
Stage Iv ◽  
Stage Iv Melanoma

A phase II study of ABT-510 for the treatment of metastatic melanoma

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 8041-8041 ◽  
Author(s):  
S. Markovic ◽  
V. Suman ◽  
R. Rao ◽  
E. Creagan ◽  
W. Maples ◽  
...  
Keyword(s):  
Metastatic Melanoma ◽  
Phase Ii ◽  
Clinical Efficacy ◽  
Phase Ii Study ◽  
Single Agent ◽  
Stage Iv ◽  
Endothelial Cell Migration ◽  
Circulating Endothelial Cells ◽  
Phase Ii Trials ◽  
Stage Iv Melanoma

8041 Background: ABT-510 is a synthetic peptide analog of thrombospondin-1 demonstrating inhibition of VEGF/bFGF mediated human endothelial cell migration, proliferation, tube formation, cornea-neovascularization as well as inhibition of tumor growth in vivo (B16F10 melanoma). Having been found to be safe in phase I testing, ABT-510 has entered phase II trials. Presented are the results of a phase II study using ABT-510 for the treatment of stage IV melanoma. Methods: A two stage phase II clinical trial was conducted to assess the anti-tumor activity, safety profile and pharmacodynamics of ABT510 in patients with stage IV melanoma. Patients self-administered 100mg of ABT-510 subcutaneously twice/day. Therapy was continued in the absence of excessive toxicity or tumor progression. Primary endpoint was 18 week progression free survival rate. Enrolled were patients at least 18 years of age with measurable (RECIST) metastatic melanoma, ECOG performance status of 0–2 and normal pre-registration blood tests. Exclusion criteria included: cancer therapy less than 4 weeks prior to registration; failure to recover from prior therapy; brain metastases; significant recent bleeding; uncontrolled hypertension; and ongoing anti-coagulation. Pregnant or nursing women were not eligible. Results: Twenty-one patients (67% male) were enrolled with a median age of 55 years. Most patients had M1c disease (80%) and 62% had prior chemotherapy for stage IV melanoma. None of the patients were ineligible/canceled participation. After the first stage of the trial was complete, only 3 of the first 20 patients enrolled were progression-free at 18 weeks. Having not met the minimal clinical efficacy requirement (at least 7 of the first 20 patients progression-free at 18 weeks) the trial was closed to further accrual. Correlative laboratory studies suggested decreases in some of the measured parameters of angiogenesis (VEGFC, circulating endothelial cells) with no impact on immune homeostasis. Conclusions: Single agent ABT-510 therapy administered at 100mg twice/day to patients with previously treated metastatic melanoma did not demonstrate significant clinical efficacy. However, changes in measured parameters of angiogenesis suggest possible clinical efficacy with higher dosing or in combination with cytotoxic therapy. [Table: see text]

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