Study of Immune Responses in Patients With Metastatic Melanoma

NCT01416844 | Withdrawn Phase 2

• 1 other identifier: PH&S IRB 10-090
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, anti-OX40 will be given to patients with melanoma to find out how the immune system responds to treatment with anti-OX40. It is hoped that this treatment will cause an immune response against melanoma resulting in tumor regression, but this is not known at this time. Anti-OX40 is a large protein that can help immune cells that fight bacteria, viruses and cancer cells.

Conditions

Metastatic Melanoma

Keywords

Metastatic melanoma; anti-OX40; Immunostimulatory

Outcome Measures

Primary Outcomes (1)

• Increased number of tumor antigen specific circulating T Cells

  T Cells will be harvested by apheresis at baseline and Day 15 following anti-OX40 administration.

  Screening (baseline) and Day 15

Interventions

anti-OX40 BIOLOGICAL

Patients with metastatic melanoma will be given 0.4 mg/kg anti-OX40 on days 1, 3 and 5 of a single treatment cycle.

Eligibility Criteria

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

You may qualify if:

• Patients with measurable or evaluable unresectable, stage IV metastatic melanoma. Either histologic or cytologic diagnosis is acceptable.
• Eastern Cooperative Oncology Group (ECOG) performance status 0, or 1 (Appendix A.)
• Age 18 years or above.
• Laboratory values (performed within 28 days prior to enrollment) as follows:
• WBC ≥2000/microliter
• Absolute lymphocyte count \>300/mm3
• Serum creatinine \<1.5 X upper limit of laboratory normal
• Hgb \>8g/dl (patients may be transfused to reach this level)
• Hct \> 24%
• Platelets \>100,000 cells/mm3
• Total bilirubin \<1.5 X upper limit of laboratory normal, unless due to Gilbert's disease
• AST (SGOT)/ALT (SGPT) \<2.5 X upper limit of laboratory normal
• Alkaline phosphatase \<2.5 X upper limit of laboratory normal
• HIV Negative
• Hepatitis B surface antigen Negative

You may not qualify if:

• Active infection.
• History of or active autoimmune disease.
• Prior mouse monoclonal antibody treatment.
• Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus.
• Need for chronic maintenance oral steroids.
• Active brain metastatic disease. Treated brain metastases with surgery, gamma-knife radiosurgery and/or whole brain radiation and stable for at least 4 weeks and off steroids are eligible.
• Any medical or psychiatric condition that in the opinion of the PI would preclude compliance with study procedures.

Sponsors & Collaborators

• Providence Health & Services: lead

Study Sites (1)

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

MeSH Terms

Conditions

Melanoma

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

• Brendan D Curti, MD

  Providence Health & Services

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 12, 2011
• First Posted: August 15, 2011
• Study Start: September 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: March 7, 2013

Record last verified: 2013-03

Locations

US (1)