VEGF Trap in Treating Patients With Recurrent Stage III or Stage IV Melanoma That Cannot Be Remov… (NCT00450255) | Clinical Trial Compass
CompletedPhase 2
VEGF Trap in Treating Patients With Recurrent Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
United States41 participantsStarted 2007-06
Plain-language summary
This phase II trial is studying how well VEGF Trap works in treating patients with recurrent stage III or stage IV melanoma that cannot be removed by surgery. Combinations of biological substances in VEGF Trap may be able to carry tumor-killing substances directly to melanoma cells. It may also stop the growth of melanoma by blocking blood flow to the tumor.
Who can participate
Age range18 Years – 120 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically confirmed stage III or IV melanoma
* Cutaneous, ocular, or mucosal melanoma allowed
* Recurrent, inoperable disease
* Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
* No evidence of CNS disease, including primary brain tumor or brain metastases
* No brain metastases by MRI or CT scan within the past 4 weeks
* ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
* Life expectancy \> 3 months
* WBC ≥ 3,000/mm³
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 75,000/mm³
* Bilirubin \< 1.5 times upper limit of normal (ULN)
* AST and ALT ≤ 2.5 times ULN
* Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
* Urine protein:creatinine ratio \< 1 OR urine protein \< 500 mg by 24-hour urine collection
* PT INR ≤ 1.5 unless on full-dose warfarin
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment
* No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
* No history of allergic reactions attributed to compounds of similar chemical or biological composition to agents used in the study
* No serious or nonhealing wound, ulcer, or bone fracture
* No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
* No significant traumatic injury wit…
What they're measuring
1
Objective Response Rate (CR + PR)
Timeframe: Start of treatment to disease progression/recurrence, up to 5 years