Clinical trial NCT00088933 (phase 1, status: terminated)
Conditions: extensive stage small cell lung cancer, recurrent colon cancer, recurrent non-small cell lung cancer, recurrent rectal cancer, recurrent small cell lung cancer, stage iv colon cancer, stage iv non-small cell lung cancer, stage iv rectal cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2, C18.2, C18.4, C18.6, C18.7, C18.9, D12.2, D12.3, C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2, G47.13, J01.41, K11.22, K12.0, N96, F33.8, G03.2, C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2, C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: recombinant fowlpox-cea(6d)/tricom vaccine, recombinant vaccinia-cea(6d)-tricom vaccine, docetaxel, sargramostim
SMILES: [O-][N+](=O)OCC(CO[N+]([O-])=O)(CO[N+]([O-])=O)CO[N+]([O-])=O, [O-][N+](=O)OCC(CO[N+]([O-])=O)(CO[N+]([O-])=O)CO[N+]([O-])=O, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed lung OR colorectal cancer

          -  Incurable metastatic disease

          -  Currently available standard treatment not likely to offer a survival advantage or
             result in superior palliation

          -  Evaluable disease by radiograph

          -  Tumor must currently express carcinoembryonic antigen (CEA) by immunohistochemistry OR
             CEA >= 10 ng/mL at any point during disease course

          -  No clinically active brain metastases

          -  Must have had first- and second-line treatment OR declined second-line treatment (part
             I only)

          -  Patients with colon cancer must have had or have been offered treatment with
             oxaliplatin (part I only)

          -  ECOG 0-1

          -  Life expectancy of at least 4 months

          -  Absolute neutrophil count >= 1,500/mm^3

          -  WBC >= 3,000/mm^3

          -  Platelet count >= 100,000/mm^3

          -  Bilirubin normal

          -  Meets 1 of the following criteria:

               -  SGOT and SGPT =< 2.5 times upper limit of normal (ULN) AND alkaline phosphatase
                  normal

               -  SGOT and SGPT =< normal AND alkaline phosphatase =<4.0 times ULN

          -  Hepatitis B and C negative by clinical history and physical exam

          -  Creatinine =< 1.5 mg/dL OR creatinine clearance >= 60 mL/min

          -  Proteinuria =< grade 1

          -  No known or suspected history of impaired cardiac function as evidenced by baseline
             echocardiogram

          -  Adequate pulmonary function

          -  No history or clinical evidence of immune deficiency or autoimmunity

          -  HIV negative

          -  No history of or concurrent diagnosis of any of the following:

               -  Altered immunodeficiency

               -  Eczema or other eczematoid skin disorders

               -  Acute, chronic, or exfoliative skin condition (e.g., atopic dermatitis, burns,
                  impetigo, varicella zoster, severe acne, or other open rashes or wounds)

          -  No history of allergy or untoward reaction to prior vaccination with vaccinia virus

          -  No history of severe hypersensitivity reaction to docetaxel or other drugs formulated
             with polysorbate 80

          -  No history of allergy to eggs or egg products

          -  No frequent vomiting or severe anorexia

          -  No inflammatory bowel disease

          -  No Crohn's disease

          -  No ulcerative colitis

          -  No active diverticulitis

          -  Neuropathy =< grade 1 (sensory neuropathy)

          -  No uncontrolled seizure disorder

          -  No encephalitis

          -  No multiple sclerosis

          -  Must be maintaining a reasonable state of nutrition (=< 10 % weight loss in the past
             month)

          -  Must be able to avoid close household contact (defined as sharing housing or having
             close physical contact) for at least 3 weeks after recombinant vaccinia vaccination
             with individuals with active or a history of eczema or other eczematoid skin disorders

          -  Must be able to avoid close household contact (defined as sharing housing or having
             close physical contact) for at least 3 weeks after recombinant vaccinia vaccination
             with those with unresolved acute, chronic, or exfoliative skin conditions (e.g.,
             atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or other open
             rashes or wounds)

          -  Must be able to avoid close household contact (defined as sharing housing or having
             close physical contact) for at least 3 weeks after recombinant vaccinia vaccination
             with any of the following individuals: pregnant or nursing women; children =< 5 years
             of age; immunodeficient or immunosuppressed individuals (by disease or therapy),
             including HIV infection

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for at least 6 months
             after study participation

          -  No other concurrent serious medical illness that would preclude study participation

          -  No concurrent biologic therapy

          -  No other concurrent immunotherapy

          -  At least 6 weeks since prior nitrosoureas or mitomycin

          -  Prior docetaxel allowed (part I only)

          -  No prior docetaxel (part II only)

          -  No other concurrent chemotherapy

          -  No concurrent systemic steroids except for the following:

               -  physiologic doses for systemic steroid replacement therapy

               -  local (topical, nasal, or inhaled) steroid use

               -  no concurrent steroid eye drops

               -  premedication prior to and after docetaxel

          -  No concurrent hormonal therapy

          -  No prior radiotherapy to > 50 % of all nodal groups

          -  More than 21 days since prior major surgery

          -  No prior splenectomy

          -  Recovered from prior therapy

          -  At least 3-4 weeks since prior cytotoxic therapy