A Phase I/II Study of CR011-vcMMAE in Subjects With Unresectable Stage III or Stage IV Melanoma

Sponsor

CuraGen Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT00412828

Collaborator

(none)

117

Enrollment

Locations

Duration (Months)

29.3

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Unresectable Stage III or Stage IV Melanoma	Drug: CR011-vcMMAE	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

117 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase I/II Study of CR011-vcMMAE in Subjects With Unresectable Stage III or Stage IV Melanoma

Study Start Date :

Jun 1, 2006

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

May 1, 2011

Outcome Measures

Primary Outcome Measures

to evaluate the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) [throughout the study]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Angeles Clinic and Research Institute	Santa Monica	California	United States	90404
2	Yale University	New Haven	Connecticut	United States	06520
3	New York University Medical Center	New York	New York	United States	10016
4	M.D. Anderson Cancer Center	Houston	Texas	United States	77030