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

This study has been completed.
Sponsor:
Information provided by:
CuraGen Corporation
ClinicalTrials.gov Identifier:
NCT00412828
First received: December 18, 2006
Last updated: June 6, 2011
Last verified: June 2011
  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 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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 ]

Enrollment: 117
Study Start Date: June 2006
Study Completion Date: May 2011
Primary Completion Date: December 2010 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
Angeles Clinic and Research Institute
Santa Monica, California, United States, 90404
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06520
United States, New York
New York University Medical Center
New York, New York, United States, 10016
United States, Texas
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
CuraGen Corporation
  More Information

No publications provided

Responsible Party: Vice President, Clinical Development, Celldex Therapeutics
ClinicalTrials.gov Identifier: NCT00412828     History of Changes
Other Study ID Numbers: CR011-CLN-11
Study First Received: December 18, 2006
Last Updated: June 6, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by CuraGen Corporation:
Melanoma
CR011-vcMMAE

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014