Study of Immune Responses in Patients With Metastatic Melanoma

Metastatic Melanoma Clinical Trial

Official title:

Phase II Exploratory Study of Immune Responses in Patients With Metastatic Melanoma Treated With Mouse Monoclonal Anti-OX40

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01416844
• Other study ID #: PH&S IRB 10-090
• Status: Withdrawn
• Phase: Phase 2
• First received: August 12, 2011
• Last updated: March 6, 2013
• Start date: September 2012
• Est. completion date: September 2012

Study information

• Verified date: March 2013
• Source: Providence Health & Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Melanoma
• Metastatic Melanoma

Intervention

Biological:
• 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.

Locations

Country	Name	City	State
United States	Providence Portland Medical Center	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Providence Health & Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No