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Phase 1 Trial of a Monoclonal Antibody to OX40 in Patients With Advanced Cancer.


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Advanced Cancer.

Thank you

Trial Information

Phase 1 Trial of a Monoclonal Antibody to OX40 in Patients With Advanced Cancer.


This study will evaluate the safety and determine the maximal tolerated dose of anti-OX40;
evaluated the immune response to the study treatment; measure the pharmacokinetics of
anti-OX40; monitor tumor regression, and identify the most biologically active dose of
anti-OX40 to induce antigen-specific responses to a variety of immunogens.


Inclusion Criteria:



- Patients with uncurable metastatic carcinoma, lymphoma, or sarcoma.

- ECOG performance status 0, 1, 2

- No active bleeding

- No clinical coagulopathy

- Anticipated lifespan greater than 12 weeks

Exclusion Criteria:

- Active residual toxicity from prior therapies

- Active Infection

- HIV positive

- Hepatitis B or C positive

- Pregnant or nursing women

- Requirement for oral steroids

- Brain metastases

- Presence or history of autoimmune disease

- Shellfish or tetanus allergy

- Splenomegaly

- Lymph nodes greater than 10 cm in maximal diameter

- Uncontrolled angina or class II or IV heart failure

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose limiting toxicity

Outcome Description:

A dose limiting toxicity is defined as any grade >=3 hematologic (except lymphopenia) or non-hematologic toxicity (except hypothyroidism or vitiligo) that, in the opinion of the investigator is considered at lease possibly related to the study treatment. If DLT is observed in greater than two patient in any cohort, then the previous cohort will be the maximal tolerated dose.

Outcome Time Frame:

28 Days

Safety Issue:

Yes

Principal Investigator

Brendan Curti, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Providence Health & Services

Authority:

United States: Food and Drug Administration

Study ID:

03-066A

NCT ID:

NCT01644968

Start Date:

November 2003

Completion Date:

January 2015

Related Keywords:

  • Advanced Cancer.
  • metastatic carcinoma
  • lymphoma
  • sarcoma
  • anti-OX40
  • Neoplasms

Name

Location
Providence Cancer Center Portland, Oregon  97213-2933