Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over Pharmaceutical / Industry 206-MM-201 NCT00369395

Trial Description

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.

Eligibility 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.

Trial Contact Information

Trial Lead Organizations/Sponsors

Protein Design Labs, Incorporated

Michael Steven Gordon

Principal Investigator

Antoni Ribas, M.D.

Principal Investigator

Lawrence E. Flaherty, M.D.

Principal Investigator

Gerald P. Linette

Principal Investigator

Tsiporah Shore, M.D.

Principal Investigator

F. Stephen Hodi, M.D.

Principal Investigator

John J. Nemunaitis, M.D.

Principal Investigator

Rene Gonzalez, M.D.

Principal Investigator

James M. Burke, MD

Principal Investigator

Gregory Daniels, MD PhD

Principal Investigator

Omid Hamid, MD

Principal Investigator

Joe J. Stephenson Jr., MD

Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00369395
Information obtained from ClinicalTrials.gov on August 05, 2008