A Study of Volociximab in Metastatic Melanoma

This study has been terminated.
(Insufficient clinical activity)
Sponsor:
Collaborator:
Biogen Idec
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT00369395
First received: August 24, 2006
Last updated: April 25, 2012
Last verified: April 2012
  Purpose

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 Intervention Phase
Stage IV Melanoma
Drug: volociximab
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 2, Open-Label, Two-Stage Study of Volociximab (M200) for the Treatment of Subjects With Metastatic Melanoma

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics of volociximab [ Time Frame: Every infusion and follow up visit ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 19
Study Start Date: December 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

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

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.
  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: NCT00369395

Locations
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
Abbott
Biogen Idec
Investigators
Study Director: Mihail Obrocea, MD Abbott
  More Information

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT00369395     History of Changes
Other Study ID Numbers: 206-MM-201
Study First Received: August 24, 2006
Last Updated: April 25, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
melanoma
antibody
angiogenesis
volociximab

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 July 26, 2014