A Study of Volociximab in Metastatic Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00369395
Recruitment Status : Terminated (Insufficient clinical activity)
First Posted : August 29, 2006
Last Update Posted : April 27, 2012
Information provided by (Responsible Party):

Brief Summary:

This is a Phase 2, multicenter, research study determining the effects of an investigational drug called volociximab in metastatic melanoma.

The purpose of the study is to compare the clinical benefit and safety of volociximab. Pharmacokinetics and mechanism of action will also be evaluated.

Condition or disease Intervention/treatment Phase
Stage IV Melanoma Drug: volociximab Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Open-Label, Two-Stage Study of Volociximab (M200) for the Treatment of Subjects With Metastatic Melanoma
Study Start Date : December 2006
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Volociximab
Volociximab 15 mg/kg
Drug: volociximab
Volociximab, 15 mg/kg, IV infusion once a week for 8 weeks. Subjects who achieved SD or better at Day 50 ± 2 days (Week 8) were eligible to continue receiving weekly infusions of volociximab until disease progression.

Primary Outcome Measures :
  1. Progression Free Survival (PFS) rate at the Week 8 visit, defined as the number of subjects who have not progressed by the Week 8 visit [ Time Frame: 8 weeks intervals ]

Secondary Outcome Measures :
  1. Pharmacokinetics of volociximab [ Time Frame: Every infusion and follow up visit ]
  2. Assess safety by recording and evaluating adverse events (AEs); changes in vital signs, hematology, blood chemistry, and urinalysis parameters; and anti-volociximab antibody formation [ Time Frame: Throught study and follow up period,approx. 15 months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

  1. Must give written informed consent and any authorizations required by local law (e.g., Protected Health Information [PHI]).
  2. Aged >=18 years old at the time of informed consent.
  3. Stage III and Stage IV unresectable melanoma with documented progression during or following the most recent prior melanoma therapy.
  4. Must have failed at least 1 prior therapy for metastatic disease.
  5. Must have at least 2 cutaneous, subcutaneous, or nodal metastases that are safely accessible for pre treatment and post treatment biopsies.
  6. Must agree to pre-treatment and post-treatment biopsies of tumor lesions (subjects in Stage 1 only).
  7. Must have at least 1 measurable target lesion for CT/MRI assessment, according to RECIST criteria.
  8. ECOG Performance Status <=1.
  9. Acceptable laboratory results
  10. Life expectancy >=12 weeks.
  11. Male subjects and female subjects of child bearing potential must be willing to practice effective contraception during the study and be willing and able to continue contraception for 4 months after last infusion of study treatment.

Exclusion Criteria

  1. Subjects with any other active malignancy in addition to metastatic melanoma.
  2. CNS metastases, unless stable for at least 2 months following definitive local therapy (surgery, stereotactic radiation). Subjects may not require treatment with steroids or anticonvulsants.
  3. History of any other significant medical condition, including cardiovascular, pulmonary, neurologic, or autoimmune disease; active infections (e.g., bacterial or fungal); or a psychiatric condition within 6 months of Day 1
  4. History of hepatitis B or C.
  5. Known history of HIV infection or AIDS.
  6. History of thromboembolic or cerebrovascular events, such as stroke, transient ischemic attack, deep vein thrombosis, or bleeding disorders within 12 months prior to Day 1.
  7. Prior radiation therapy, chemotherapy, hormonal therapy, or immunotherapy for melanoma within 4 weeks prior to Day 1.
  8. Previous exposure to volociximab.
  9. Aspirin, high dose warfarin, or heparin use. (Note: Aspirin <=81 mg/day, low-dose warfarin 1 mg/day or low-dose heparin for IV catheter patency is allowed.)
  10. Major surgery within 4 weeks prior to Day 1.
  11. Requirement for immunosuppression, and/or systemic steroid therapy.
  12. Investigational therapies within 4 weeks prior to Day 1 or 4 half lives of the prior investigational drug (whichever is longer).
  13. Known hypersensitivity to murine or chimeric antibodies.
  14. Any condition that, in the opinion of the Investigator, makes the subject unsuitable for study participation.
  15. Female subjects who are pregnant or currently breastfeeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00369395

United States, Arizona
Site Reference ID/Investigator# 70357
Scottsdale, Arizona, United States, 85258
United States, California
Site Reference ID/Investigator# 70356
La Jolla, California, United States, 92093
United States, Colorado
Site Reference ID/Investigator# 70375
Aurora, Colorado, United States, 80045
United States, Massachusetts
Site Reference ID/Investigator# 70376
Boston, Massachusetts, United States, 02115
United States, Missouri
Site Reference ID/Investigator# 70359
St. Louis, Missouri, United States, 63110
United States, South Carolina
Site Reference ID/Investigator# 70380
Greenville, South Carolina, United States, 29605
United States, Texas
Site Reference ID/Investigator# 70377
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Study Director: Mihail Obrocea, MD Abbott

Responsible Party: Abbott Identifier: NCT00369395     History of Changes
Other Study ID Numbers: 206-MM-201
First Posted: August 29, 2006    Key Record Dates
Last Update Posted: April 27, 2012
Last Verified: April 2012

Keywords provided by Abbott:

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