A Study of Volociximab in Metastatic Melanoma

Stage IV Melanoma Clinical Trial

Official title:

A Phase 2, Open-Label, Two-Stage Study of Volociximab (M200) for the Treatment of Subjects With Metastatic Melanoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00369395
• Other study ID #: 206-MM-201
• Status: Terminated
• Phase: Phase 2
• First received: August 24, 2006
• Last updated: April 25, 2012
• Start date: December 2006
• Est. completion date: March 2008

Study information

• Verified date: April 2012
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Stage IV Melanoma

Intervention

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.

Locations

Country	Name	City	State
United States	Site Reference ID/Investigator# 70375	Aurora	Colorado
United States	Site Reference ID/Investigator# 70376	Boston	Massachusetts
United States	Site Reference ID/Investigator# 70377	Dallas	Texas
United States	Site Reference ID/Investigator# 70380	Greenville	South Carolina
United States	Site Reference ID/Investigator# 70356	La Jolla	California
United States	Site Reference ID/Investigator# 70357	Scottsdale	Arizona
United States	Site Reference ID/Investigator# 70359	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Abbott	Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Pharmacokinetics of volociximab		Every infusion and follow up visit	No
Secondary	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	Yes