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A Phase I/II Study of CR011-vcMMAE in Subjects With Unresectable Stage III or Stage IV Melanoma
This study is currently recruiting participants.
Verified by CuraGen Corporation, December 2008
Sponsored by: CuraGen Corporation
Information provided by: CuraGen Corporation
ClinicalTrials.gov Identifier: NCT00412828
  Purpose

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 Intervention Phase
Unresectable Stage III or Stage IV Melanoma
Drug: CR011-vcMMAE
Phase I
Phase II

MedlinePlus related topics: Cancer Melanoma
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase I/II Study of CR011-vcMMAE in Subjects With Unresectable Stage III or Stage IV Melanoma

Further study details as provided by CuraGen Corporation:

Primary Outcome Measures:
  • to evaluate the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • to evaluate the immune response to CR011-vcMMAE [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • to assess the pharmacodynamics and pharmacokinetics of CRO11-vcMMAE [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • to explore clinical anti-tumor response of CR011-vcMMAE in subjects with advanced metastatic melanoma [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 135
Study Start Date: June 2006
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: CR011-vcMMAE
    administered as an intravenous infusion of 250 mL over 90 min
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00412828

Contacts
Contact: CuraGen Clinical Trial Call Center 1-877-462-4363 info@curagen.com

Locations
United States, California
Angeles Clinic and Research Institute Recruiting
Santa Monica, California, United States, 90404
Contact: Omid Hamid, MD     310-231-2121     ohamid@theangelesclinic.org    
Principal Investigator: Steven O'Day, MD            
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06520
Contact: Call For Information     877-462-4363     info@curagen.com    
Principal Investigator: Mario Sznol, M.D.            
United States, New York
New York University Medical Center Recruiting
New York, New York, United States, 10016
Contact: Call for Information     877-462-4363     info@curagen.com    
Principal Investigator: Anna Pavlick, DO            
United States, Texas
M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Call For Information     877-462-4363     info@curagen.com    
Principal Investigator: Patrick Hwu, M.D.            
Sponsors and Collaborators
CuraGen Corporation
  More Information

Responsible Party: CuraGen Corporation ( Vice President, Regulatory Affairs and Quality Assurance. )
Study ID Numbers: CR011-CLN-11
Study First Received: December 18, 2006
Last Updated: December 1, 2008
ClinicalTrials.gov Identifier: NCT00412828  
Health Authority: United States: Food and Drug Administration

Keywords provided by CuraGen Corporation:
Melanoma
CR011-vcMMAE

Study placed in the following topic categories:
Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Nevus
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on January 14, 2009