Vaccine Therapy and Sargramostim With or Without Docetaxel in Treating Patients With Metastatic Lung Cancer or Metastatic Colorectal Cancer
Extensive Stage Small Cell Lung Cancer, Recurrent Colon Cancer, Recurrent Non-small Cell Lung Cancer
About this trial
This is an interventional treatment trial for Extensive Stage Small Cell Lung Cancer
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
Sites / Locations
- Lombardi Comprehensive Cancer Center at Georgetown University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm I
Arm II
Arm III
Arm IV
Arm V
Arm VI
Three weeks after treatment with vaccinia-CEA-TRICOM vaccine, patients receive fowlpox-CEA-TRICOM vaccine SC on day 1 and GM-CSF SC into each vaccination site on days 1-4.
Patients receive fowlpox-CEA-TRICOM vaccine and GM-CSF as in arm I and lower-dose docetaxel IV over 30 minutes on days 1 and 8.
Patients receive fowlpox-CEA-TRICOM vaccine and GM-CSF as in arm I and standard-dose docetaxel IV over 30 minutes on days 1 and 8.
Patients receive fowlpox-CEA-TRICOM vaccine and GM-CSF as in arm I and full-dose docetaxel IV over 1 hour on day 1.
Patients receive full-dose docetaxel IV over 1 hour on day 1, fowlpox-CEA-TRICOM vaccine SC on day 8, and GM-CSF SC into each vaccination site on days 8-11.
Patients receive full-dose docetaxel as in arm V, fowlpox-CEA-TRICOM vaccine SC on day 15, and GM-CSF SC into each vaccination site on days 15-18.