Unresectable Stage III or Stage IV Melanoma
Conditions
Keywords
Melanoma, CR011-vcMMAE
Brief summary
This study will evaluate the safety, tolerability and pharmacokinetics of CR011-vcMMAE in patients who have unresectable stage III or stage IV melanoma and have failed no more than 1 line of prior cytotoxic therapy. CR011-vcMMAE will be administered intravenously (IV) once every 3 weeks at escalating doses until the maximum tolerated dose (MTD) is reached. Once the MTD is defined, 18-32 patients will be enrolled to further evaluate the safety and efficacy of CR011-vcMMAE at this dose level. Additional dosing schedules of CR011-vcMMAE will also be explored.
Interventions
DRUGCR011-vcMMAE
administered as an intravenous infusion of 250 mL over 90 min
Sponsors
CuraGen Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female with age ≥ 18 years. * Progressive or new metastatic melanoma, stage III or IV. * Measurable disease by CT / MRI * Failure of no more than 1 line of prior cytotoxic therapy. * Adequate bone marrow, renal and hepatic function * Leukocytes ≥ 3000/mm3, ANC ≥ 1,500 cells/mm3, Platelets ≥ 100,000/mm3 * Hemoglobin ≥ 10 g/dL (transfusion allowed) * Total bilirubin ≤ 1.5 x upper normal limit (UNL) * AST (SGOT), ALT (SGPT) ≤ 3.0 x UNL (≤ 5.0 x UNL may be acceptable) * Serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance \> 45 mL/min/1.73 m2 * PT/aPTT \< 1.5 x UNL or within therapeutic range via anti-coagulation therapy * Karnofsky PS ≥ 70%. * Estimated life expectancy \> 3 months. * Signed informed consent approved IRB and ability to comply with the study or monitoring procedures. * Subjects with evaluable disease are eligible in dose-escalation cohorts
Exclusion criteria
* Prior therapies for disease under study less than 4 weeks prior to enrollment. * Major surgery or trauma within 4 weeks of enrollment. * Active brain metastases * Active chronic inflammatory, autoimmunity, immunodeficiency disease, and vascular or hemorrhagic disorders. * History of allergic reactions to dolastatin, auristatin or compounds of similar composition. * Significant cardiovascular disease * Other malignancies * Pregnancy or breast feeding * Refusal or inability to use effective means of contraception (for men, and women with childbearing potential) * History of or test-positive to HIV, or hepatitis B or C
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| to evaluate the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) | throughout the study |
Secondary
| Measure | Time frame |
|---|---|
| to evaluate the immune response to CR011-vcMMAE | throughout the study |
| to assess the pharmacodynamics and pharmacokinetics of CRO11-vcMMAE | throughout the study |
| to explore clinical anti-tumor response of CR011-vcMMAE in subjects with advanced metastatic melanoma | throughout the study |
Countries
United States
Outcome results
None listed