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Vaccine Therapy in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Vaccine Therapy in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Vaccine Therapy in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer Clinical research trials and Vaccine Therapy in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Vaccine Therapy in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer. Vaccine Therapy in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Vaccine Therapy in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer clinical trial. Test subjects typically receive the most expert healthcare available for their Vaccine Therapy in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "V" Clinical Trials Conditions > Vaccine Therapy in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer  Vaccine Therapy in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer
Vaccine Therapy in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer
For Condition: stage 1 non-small cell lung cancer,stage 3A non-small cell lung cancer,stage 2 non-small cell lung cancer
Status: Terminated
Sponsor(s): Jonsson Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune response and kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have stage I, stage II, or stage III non-small cell lung cancer.
Details: OBJECTIVES: - Determine the safety of mature autologous dendritic cells loaded with irradiated autologous tumor cells (DCVax-Lung) in patients with non-small cell lung cancer. - Determine the feasibility of this regimen in these patients. - Evaluate the anti-tumor immunity in patients treated with this regimen. - Document the immunosuppressive environment both before and after tumor resection in patients treated with this regimen. OUTLINE: Within 1 to 3 weeks before planned thoracotomy, patients undergo leukapheresis for collection of peripheral blood mononuclear cells (PBMC). PBMC are cultured to generate dendritic cells (DC). DC are loaded with irradiated autologous tumor cells obtained at resection (DCVax-Lung). After recovery from thoracotomy, the first 4 patients receive low-dose DCVax-Lung intradermally (ID). One week after the last patient in the first cohort receives DCVax-Lung, 4 additional patients receive intermediate-dose DCVax-Lung ID. One week after the last patient in the second cohort receives DCVax-Lung, the final 4 patients receive high-dose DCVax-Lung ID. Treatment for all cohorts repeats monthly for 3 courses in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for 2 months, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study within 6-12 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed non-small cell lung cancer - Surgically resectable tumor - Stage IB (T2N0) OR - Stage IIB (T2N1 or T3N0) with negative mediastinoscopy OR - Stage IIIA (T3N1) with negative mediastinoscopy OR - Stage IIIA (T2N2 or T3N2) based upon incidentally discovered positive N2 nodes noted upon pathologic examination post-thoracotomy - Planned thoracotomy PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Zubrod 0-1 Life expectancy - Not specified Hematopoietic - Platelet count at least 100,000/mm3 - WBC at least 3,000/mm3 - Absolute neutrophil count at least 1,500/mm3 - Hematocrit at least 30% Hepatic - Bilirubin no greater than 2 times upper limit of normal (ULN) - AST/ALT no greater than 3 times ULN - Hepatitis B surface antigen negative - Anti-hepatitis core antigen negative - ALT-surrogate marker negative for non A, B, and C hepatitis virus - Anti-hepatitis C virus negative Renal - Creatinine no greater than 2.2 mg/dL - BUN no greater than 40 mg/dL Pulmonary - No more than 2 chronic obstructive pulmonary disease exacerbations requiring steroids and/or hospitalization within the past year - FEV1 greater than 2.0 L OR - Predicted post-resection FEV1 greater than 1 L Other - HIV negative - Anti-HIV 1 and 2 antibody negative - Anti-human T lymphotropic virus 1 (HTLV-1) negative - No syphilis - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix - No known autoimmune/collagen vascular disorder - No underlying conditions that would preclude study - No allergy to reagents used in this study - No acute viral, bacterial, or fungal infections requiring therapy - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - No concurrent corticosteroids for another illness for more than 2 weeks duration Radiotherapy - Not specified Surgery - See Disease Characteristics - No prior organ allografts Other - At least 7 days since prior acute therapy for acute infections - No concurrent medications that may affect immune function except nonprescription strength nonsteroidal anti-inflammatory drugs, acetaminophen, ibuprofen, or aspirin, low-dose antihistamines for colds or allergies, vitamin supplements, cimetidine or other H2 blockers, or short courses of antibiotics for minor infection
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BarbaraGitlitz, Study Chair, University of California, Los Angeles
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90024
United States
Additional Information:
Study ID Numbers: CDR0000256299; UCLA-0201030,NWBT-DC1-NSCLC,NCI-G02-2100
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00043160
Other Stage 2 Non-Small Cell Lung Cancer Studies:
1. Combination Chemotherapy Plus Radiation Therapy With or Without AE-941 in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed By Surgery
2. Combination Chemotherapy, Gefitinib, and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer
3. Chemotherapy and Radiation Therapy With or Without Efaproxiral in Treating Patients With Stage III Non-Small Cell Lung Cancer
4. Genetic Changes in Patients With Non-Small Cell Lung Cancer Who Are Receiving Vinorelbine and Gemcitabine Before Surgery
5. Arsenic Trioxide in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Related Studies:
Other stage 2 non-small cell lung cancer Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Vaccine Therapy in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer
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