Cetuximab and Lenalidomide in Head and Neck
Condition: Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell
Intervention: Cetuximab and Lenalidomide
Intervention description: The treatment of Head and Neck Cancer with Cetuximab and Lenalidomide
Intervention MeSH terms: Lenalidomide; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Head and Neck, Squamous Cell; Recurrent or metastatic squamous cell or undifferentiated carcinoma of the head and neck that is not amenable to curative therapy

Summary:

      The purpose of this study is to study specific FcRIIIa polymorphisms and their correlation
      with clinical outcome in subjects treated with cetuximab and lenalidomide.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Understand and voluntarily sign an informed consent form.

          2. Age ≥18 years at the time of signing the informed consent form.

          3. Able to adhere to the study visit schedule and other protocol requirements.

          4. Recurrent or metastatic squamous cell or undifferentiated carcinoma of the head and
             neck that is not amenable to curative therapy. Patients who are candidates for local
             or locoregional therapy should not be deprived of proven beneficial palliative
             therapies.

          5. All previous cancer therapy, including radiation, hormonal therapy, EGFR inhibitors,
             and surgery, must have been discontinued at least 4 weeks prior to treatment in this
             study.

          6. ECOG performance status of 0-1 at study entry.

          7. Laboratory test results within these ranges:

               -  Absolute neutrophil count to ≥ 1000/mm³

               -  Platelet count ≥ 100,000/mm³

               -  Calculated creatinine clearance ≥ 50ml/min by Cockcroft-Gault estimation

               -  Total bilirubin < 1.5 x ULN

               -  AST (SGOT) and ALT (SGPT) < 3 x ULN or < 5 x ULN if hepatic metastases are
                  present.

          8. Disease free of prior malignancies for < 3 years with exception of currently treated
             basal cell, squamous cell carcinoma of the skin, or carcinoma "in-situ" of the cervix
             or breast. Patients with malignancies diagnosed less than 3 years prior to study entry
             are eligible if the first cancer was no greater than stage I and did not recur.
             Patients with malignancies diagnosed less than 3 years prior to study entry must have
             the diagnosis of recurrent or metastatic squamous cell carcinoma of the head and neck
             confirmed pathologically.

          9. All study participants must be registered into the mandatory RevAssist® program, and
             be willing and able to comply with the requirements of RevAssist®.

         10. Females of childbearing potential (FCBP)† must have a negative serum or urine
             pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to
             and again within 24 hours of prescribing lenalidomide (prescriptions must be filled
             within 7 days) and must either commit to continued abstinence from heterosexual
             intercourse or begin TWO acceptable methods of birth control, one highly effective
             method and one additional effective method AT THE SAME TIME, at least 28 days before
             she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men
             must agree to use a latex condom during sexual contact with a FCBP even if they have
             had a successful vasectomy. See Appendix: Risks of Fetal Exposure, Pregnancy Testing
             Guidelines and Acceptable Birth Control Methods.

         11. Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients
             intolerant to ASA may use warfarin or low molecular weight heparin).

         12. Measurable disease, defined as at least one lesion that can be accurately measured in
             at least one dimension (longest diameter to be recorded), with minimum lesion size ≥ 2
             cm on conventional measurement techniques or ≥ 1 cm on spiral computed tomography (CT)
             scan. Lesions that can be measured clinically must be at least 1 cm in greatest
             dimension by caliper measurement.

        Exclusion Criteria:

          1. Primary head and neck carcinomas of the salivary gland, skin, or thyroid regardless of
             pathology

          2. Any serious medical condition, laboratory abnormality, or psychiatric illness that
             would prevent the subject from signing the informed consent form.

          3. Pregnant or breast feeding females. (Lactating females must agree not to breast feed
             while taking lenalidomide).

          4. Any condition, including the presence of laboratory abnormalities, which places the
             subject at unacceptable risk if he/she were to participate in the study or confounds
             the ability to interpret data from the study.

          5. Use of any other experimental drug or therapy within 28 days of baseline.

          6. Prior therapy with lenalidomide for squamous cell carcinoma of the head and neck

          7. Known hypersensitivity to thalidomide.

          8. The development of erythema nodosum if characterized by a desquamating rash while
             taking thalidomide or similar drugs.

          9. Concurrent use of other anti-cancer agents or treatments.

         10. Known positive for HIV or infectious hepatitis, type B or C.