Loading clinical trials...

A Study of Volociximab in Metastatic Melanoma | Clinical Trials | Clareo Health

TERMINATEDPHASE2

A Study of Volociximab in Metastatic Melanoma

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

NCT00369395•Abbott

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

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.
+5 more criteria

Locations (7)

Site Reference ID/Investigator# 70357

Scottsdale, Arizona, United States

Site Reference ID/Investigator# 70356

La Jolla, California, United States

Site Reference ID/Investigator# 70375

Aurora, Colorado, United States

Site Reference ID/Investigator# 70376

Boston, Massachusetts, United States

Site Reference ID/Investigator# 70359

St Louis, Missouri, United States

Site Reference ID/Investigator# 70380

Greenville, South Carolina, United States

Site Reference ID/Investigator# 70377

Dallas, Texas, United States

Key Dates

Start Date

December 1, 2006

Primary Completion Date

March 1, 2008

Completion Date

March 1, 2008

Last Updated

April 27, 2012

Enrollment

ACTUAL participants

Conditions

Stage IV Melanoma

Interventions

volociximab

DRUG

Neoadj Admin Autologous Tumor Infiltrating Lymphocytes & Pembrolizumab for Treatment of Adv Melanoma Patients

NCT05176470

Locally Advanced MelanomaPathologic Stage IIIB Cutaneous Melanoma AJCC v8+3 more

View study

WITHDRAWNPHASE1

Vemurafenib Combined With Whole Brain Radiation Therapy or Radiosurgery in Patients With BRAF Mutation-Positive Melanoma and Brain Metastases

NCT02145910

Recurrent MelanomaStage IV Melanoma+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 27, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study of Volociximab in Metastatic Melanoma

Inclusion Criteria

Exclusion Criteria

Neoadj Admin Autologous Tumor Infiltrating Lymphocytes & Pembrolizumab for Treatment of Adv Melanoma Patients

Vemurafenib Combined With Whole Brain Radiation Therapy or Radiosurgery in Patients With BRAF Mutation-Positive Melanoma and Brain Metastases

A Study of a Monoclonal Antibody, KW-2871, in Patients With Advanced Melanoma

flt3L With or Without Vaccine Therapy in Treating Patients With Metastatic Melanoma or Renal Cell Cancer

Therapeutic Autologous Lymphocytes, Aldesleukin, and Denileukin Diftitox in Treating Patients With Stage III-IV Melanoma

Study of Denileukin Diftitox in Participants With Stage IIIC and Stage IV Melanoma