Status:
COMPLETED
Vanguard Study for Head and Neck Cancer or Non-Small Cell Lung Cancer (NSCLC) Patients
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
United States Department of Defense
Conditions:
Head and Neck Cancer
Lung Cancer
Eligibility:
All Genders
18+ years
Brief Summary
The goal of this research study is to look at how long individuals who have been treated for early stage NSCLC or HNSCC live without developing lung cancer. Another goal is to develop tools to help pr...
Detailed Description
This study is known as the Vanguard Trial. When you enter this study, you will have a complete medical history (including smoking history) and physical exam, including measurement of height, weight, a...
Eligibility Criteria
Inclusion
- Patients with either: a) histologically proven stage I, II, IIIa NSCLC who have undergone a complete surgical resection of the primary tumor OR b) stage I or II HNSCC who have undergone definitive local treatment (surgery or radiation therapy).
- HNSCC patients:Definitive local treatment \</= 12 months prior to trial enrollment. NSCLC patients: Surgery \</= 12 months prior to trial enrollment.
- No evidence residual cancer
- Age \> = 18 years
- Performance status of 0- 2 (Zubrod)
- Patients must have no contraindications for undergoing bronchoscopy.
- Patients must have no active pulmonary infections.
- Participants must have the following blood levels: total granulocyte count \>1500; platelet count \> 100,000; total bilirubin \< = 1.5 mg. %; and creatinine \< = 1.5 mg %.
- Participants must complete the pretreatment evaluation and must consent to bronchoscopy and to endobronchial biopsy for biomarker studies.
- All subjects who agree to participate will be given a written and verbal explanation of the study requirements and a consent form that must be signed prior to registration. Subjects will be informed that (a) they must be willing to take biopsies through bronchoscopy and give blood samples at the specified times, (b) they must schedule and keep the specified follow-up visits with their physicians and the study clinics, and (c) side effects and health risks may occur, as described in the informed consent form.
- Smoking history of at least 10 pack years. May be current or former smoker.
- Subject must be considered legally capable of providing his or her own consent for participation in this study.
- HNSCC patients only: Must have no contraindications for undergoing laryngoscopy.
Exclusion
- History of radiation therapy to the chest. For those patients with head and neck cancer who received radiation, no more than 10% of the lung volume (apices) may be included.
- History of systemic chemotherapy. Exception: NSCLC patients may have had up to 4 cycles of platinum-based doublet therapy.
- Pregnant or breast-feeding (a negative pregnancy test within 72 hours of enrollment for women with child-bearing potential is required).
- Participants with active pulmonary infections or recent history of pulmonary infection (within one month).
- Participants with acute intercurrent illness.
- Participants requiring chronic ongoing treatment with NSAIDs except aspirin.
- Participants with history of stroke, uncontrolled hypertension, and/or uncontrolled angina pectoris.
- Patients may not take high dose antioxidants (vitamins E or C) during the study period. "High dose" will be determined by the study investigators.
- Patients may not take high dose synthetic or natural Vitamin A derivatives (\> 10,000 IU per day). "High dose" is defined as anything greater than a once-daily multivitamin. Any additional supplementation will be evaluated at the discretion of the treating physician.
- History of biologic therapy.
Key Trial Info
Start Date :
August 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00352391
Start Date
August 1 2004
End Date
January 1 2016
Last Update
February 3 2016
Active Locations (3)
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1
Eisenhower Army Medical Center
Fort Gordon, Georgia, United States, 30905
2
Conemaugh Memorial Medical Center
Johnstown, Pennsylvania, United States, 15901
3
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030