Study of Immune Responses in Patients With Metastatic Melanoma

NCT ID: NCT01416844

Last Updated: 2013-03-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2012-09-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

anti-OX40

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Patients with measurable or evaluable unresectable, stage IV metastatic melanoma. Either histologic or cytologic diagnosis is acceptable.

2. Eastern Cooperative Oncology Group (ECOG) performance status 0, or 1 (Appendix A.)

3. Age 18 years or above.

4. 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
• Hepatitis C antibody Negative

5. Women of childbearing potential must have a negative pregnancy test and must avoid becoming pregnant while on treatment. Men must avoid fathering a child while on treatment. This exclusion is required due to the unknown toxicities that anti-OX40 may have on the forming fetus, spermatogenesis or the nursing child. Also, because pregnancy may impair immune function it may limit the treatment efficacy.

6. Ability to give informed consent and comply with the protocol. Patients with a history of psychiatric illness must be judged able to understand fully the investigational nature of the study and the risks associated with the therapy.

7. No active bleeding.

8. No clinical coagulopathy (INR <1.5, PT <16 seconds, PTT < 38 seconds).

9. Anticipated lifespan greater than 12 weeks.

10. Failed at least one prior medical therapy for metastatic melanoma.

Exclusion Criteria

1. Active infection.

2. History of or active autoimmune disease.

3. Prior mouse monoclonal antibody treatment.

4. Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus.

5. Need for chronic maintenance oral steroids.

6. 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.

7. Any medical or psychiatric condition that in the opinion of the PI would preclude compliance with study procedures.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Providence Health & Services

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brendan D Curti, MD

Role: PRINCIPAL_INVESTIGATOR

Providence Health & Services

Locations

Providence Portland Medical Center

Portland, Oregon, United States

Countries

United States

Other Identifiers

PH&S IRB 10-090

Identifier Type: -

Identifier Source: org_study_id