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| Sponsor: | Lombardi Cancer Research Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00088933 |
Purpose
RATIONALE: 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.
PURPOSE: This randomized phase II trial is studying how well giving vaccine therapy together with sargramostim and docetaxel works compared to vaccine therapy and sargramostim alone in treating patients with metastatic lung cancer or metastatic colorectal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer Lung Cancer |
Drug: docetaxel Drug: recombinant fowlpox-CEA(6D)/TRICOM vaccine Drug: recombinant vaccinia-CEA(6D)-TRICOM vaccine Drug: sargramostim Procedure: biological therapy Procedure: chemotherapy Procedure: colony-stimulating factor therapy Procedure: cytokine therapy Procedure: non-specific immune-modulator therapy Procedure: recombinant viral vaccine Procedure: vaccine therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | Randomized Single Institution Pilot Study of Vaccinia-CEA (6D)-Tricomand Fowlpox CEA(6D)-Tricom With GM-CSF in Combination With Docetaxel in Patients With CEA-Bearing Cancers |
| Estimated Enrollment: | 60 |
| Study Start Date: | June 2004 |
OBJECTIVES:
OUTLINE: This is a 2-part, randomized, pilot study. Patients are randomized to 1 of 6 treatment arms: arms I, II, and III in part I (lung cancer and colorectal cancer patients) and arms IV, V, and VI in part II (lung cancer patients only). Patients are stratified according to disease site and HLA-A2 positivity (positive vs negative). At least 6 of 10 patients must be HLA-A2 positive for each of the treatment arms.
Fowlpox-CEA-TRICOM vaccine and concurrent chemotherapy:
Part I (lung cancer and colorectal cancer patients):
Part II (lung cancer patients only):
Treatment in all arms repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Patients who do not have significant disease progression or unacceptable toxicity after 4 courses of treatment may receive additional fowlpox-CEA-TRICOM vaccine and docetaxel according to the treatment arm on which they were enrolled at study entry.
Patients are followed every 6 months for 2 years and then annually for 13 years.
PROJECTED ACCRUAL: A total of 60 patients (10 per treatment arm) will be accrued for this study within 10 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed lung OR colorectal cancer
Part I only:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Meets 1 of the following criteria:
Renal
Cardiovascular
Pulmonary
Immunologic
No history of or concurrent diagnosis of any of the following:
Gastrointestinal
Neurologic
Other
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:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
No concurrent systemic steroids except for the following:
Local (topical, nasal, or inhaled) steroid use
Radiotherapy
Surgery
Other
Contacts and Locations| United States, District of Columbia | |
| Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | |
| Washington, District of Columbia, United States, 20007 | |
| Study Chair: | John L. Marshall, MD | Lombardi Cancer Research Center |
More Information
| Study ID Numbers: | CDR0000377574, GUMC-02452, NCI-6230 |
| Study First Received: | August 4, 2004 |
| Last Updated: | June 19, 2009 |
| ClinicalTrials.gov Identifier: | NCT00088933 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
recurrent small cell lung cancer stage IV non-small cell lung cancer extensive stage small cell lung cancer stage IV colon cancer |
recurrent colon cancer recurrent rectal cancer stage IV rectal cancer recurrent non-small cell lung cancer |
|
Thoracic Neoplasms Respiratory Tract Neoplasms Digestive System Neoplasms Antineoplastic Agents Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Pharmacologic Actions Intestinal Neoplasms |
Docetaxel Neoplasms Neoplasms by Site Digestive System Diseases Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Gastrointestinal Neoplasms Colorectal Neoplasms |