A Study of Volociximab in Metastatic Melanoma

NCT00369395 | Terminated Phase 2

• 1 other identifier: 206-MM-201
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 7

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.

Conditions

Stage IV Melanoma

Keywords

melanoma; antibody; angiogenesis; volociximab

Outcome Measures

Primary Outcomes (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

  8 weeks intervals

Secondary Outcomes (2)

• Pharmacokinetics of volociximab

  Every infusion and follow up visit

• Assess safety by recording and evaluating adverse events (AEs); changes in vital signs, hematology, blood chemistry, and urinalysis parameters; and anti-volociximab antibody formation

  Throught study and follow up period,approx. 15 months

Study Arms (1)

Volociximab

EXPERIMENTAL

Volociximab 15 mg/kg

Drug: volociximab

Interventions

volociximab DRUG

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.

Volociximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must give written informed consent and any authorizations required by local law (e.g., Protected Health Information \[PHI\]).
• Aged \>=18 years old at the time of informed consent.
• Stage III and Stage IV unresectable melanoma with documented progression during or following the most recent prior melanoma therapy.
• Must have failed at least 1 prior therapy for metastatic disease.
• Must have at least 2 cutaneous, subcutaneous, or nodal metastases that are safely accessible for pre treatment and post treatment biopsies.
• Must agree to pre-treatment and post-treatment biopsies of tumor lesions (subjects in Stage 1 only).
• Must have at least 1 measurable target lesion for CT/MRI assessment, according to RECIST criteria.
• ECOG Performance Status \<=1.
• Acceptable laboratory results
• Life expectancy \>=12 weeks.
• 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.

You may not qualify if:

• Subjects with any other active malignancy in addition to metastatic melanoma.
• 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.
• 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
• History of hepatitis B or C.
• Known history of HIV infection or AIDS.
• 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.
• Prior radiation therapy, chemotherapy, hormonal therapy, or immunotherapy for melanoma within 4 weeks prior to Day 1.
• Previous exposure to volociximab.
• 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.)
• Major surgery within 4 weeks prior to Day 1.
• Requirement for immunosuppression, and/or systemic steroid therapy.
• Investigational therapies within 4 weeks prior to Day 1 or 4 half lives of the prior investigational drug (whichever is longer).
• Known hypersensitivity to murine or chimeric antibodies.
• Any condition that, in the opinion of the Investigator, makes the subject unsuitable for study participation.
• Female subjects who are pregnant or currently breastfeeding.

Sponsors & Collaborators

• Abbott: lead
• Biogen: collaborator

Study Sites (7)

Site Reference ID/Investigator# 70357

Scottsdale, Arizona, 85258, United States

Location

Site Reference ID/Investigator# 70356

La Jolla, California, 92093, United States

Location

Site Reference ID/Investigator# 70375

Aurora, Colorado, 80045, United States

Location

Site Reference ID/Investigator# 70376

Boston, Massachusetts, 02115, United States

Location

Site Reference ID/Investigator# 70359

St Louis, Missouri, 63110, United States

Location

Site Reference ID/Investigator# 70380

Greenville, South Carolina, 29605, United States

Location

Site Reference ID/Investigator# 70377

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

volociximab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mihail Obrocea, MD

  Abbott

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2006
• First Posted: August 29, 2006
• Study Start: December 1, 2006
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: April 27, 2012

Record last verified: 2012-04

Locations

US (7)