Vaccine Therapy and Sargramostim With or Without Docetaxel in Treating Patients With Metastatic Lung Cancer or Metastatic Colorectal Cancer

Stopped early · Phase 1

Conditions studied: 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

In brief

This randomized phase I trial studies the side effects, best way to give, and best dose of docetaxel when given together with vaccine therapy and sargramostim in treating patients with metastatic lung cancer or metastatic colorectal cancer. Vaccines may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim increase the number of immune cells found in bone marrow and peripheral blood. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining vaccine therapy and sargramostim with docetaxel may kill more tumor cells.

Key facts

Study ID

NCT00088933

Run by

National Cancer Institute (NCI)

People needed

60

Starts

2004-06-01

Last updated by the study team

2014-03-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:

Where it is running

• Lombardi Comprehensive Cancer Center at Georgetown University — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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