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Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Locally Advanced or Metastatic Colorectal 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 With or Without Interleukin-2 in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer Clinical research trials and Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Locally Advanced or Metastatic Colorectal 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 With or Without Interleukin-2 in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer. Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Locally Advanced or Metastatic Colorectal 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 With or Without Interleukin-2 in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer clinical trial. Test subjects typically receive the most expert healthcare available for their Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Locally Advanced or Metastatic Colorectal 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 With or Without Interleukin-2 in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer  Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer
Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer
For Condition: stage 4 colon cancer,stage 3 colon cancer,stage 3 rectal cancer,Stage 4 rectal cancer,recurrent rectal cancer,recurrent colon cancer
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: RATIONALE: Vaccines may make the body build an immune response that will kill cancer cells. Combining vaccine therapy with interleukin-2 may kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy with or without interleukin-2 in treating patients who have locally advanced or metastatic colorectal cancer.
Details: OBJECTIVES: - Determine the frequency of immunologic response in patients with locally advanced or metastatic colorectal cancer treated with ras peptide-pulsed dendritic cell vaccine with or without interleukin-2. - Determine the tumor response and survival time in patients with metastatic colorectal cancer treated with vaccine plus interleukin-2. - Determine the time to progression in patients with locally advanced colorectal cancer treated with adjuvant vaccine. OUTLINE: Patients are assigned to 1 of 2 treatment groups according to extent of disease. Patients with prior locally advanced disease are assigned to treatment group A, while those with metastatic disease are assigned to treatment group B. - Group A: Patients are vaccinated against influenza on day -6. Patients undergo collection of peripheral blood mononuclear cells (PBMC) on day -4. The PBMC are cultured with sargramostim (GM-CSF) and interleukin-4 for 5 days and CD40 ligand for 24 hours and then pulsed for 2 hours with the appropriate peptide to form a vaccine. Patients receive ras peptide-pulsed dendritic cell vaccine IV over 5 minutes on days 1, 15, 29, 43, and 57. - Group B: Patients undergo collection of PBMC and receive vaccination as in group A. Patients also receive interleukin-2 subcutaneously on days 2-6 and 9-13. Treatment in both groups repeats every 2 weeks for up to 5 vaccinations in the absence of disease progression or unacceptable toxicity. Patients are followed on days 75, 90, 120, and 365. PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed locally advanced or metastatic colorectal cancer - Metastatic disease must be radiologically proven - HLA-A2-1 positive - Locally advanced disease must have had prior resection or incomplete resection with poor prognosis - Locally advanced disease includes: - Stage III or IV colon cancer (T4 or any T, N2-3, M0) - Stage III or IV rectal cancer (T4 or T3, N1-3) - Resectable or unresectable T4 disease after radiotherapy, chemotherapy, and/or surgery - Absence of measurable disease but more than a 50% chance of recurrence - Completely resected or locally advanced disease may have had conventional therapy completed within 1-12 months (surgery alone, with or without adjuvant chemotherapy and/or radiotherapy) prior to study entry - Metastatic disease patients must have bidimensionally measurable disease - Bone lesions with well-demarcated borders allowed - Lesions seen only on bone scan, pleural effusions, ascites, and changes in carcinoembryonic antigen are not considered measurable disease PATIENT CHARACTERISTICS: Age: - Over 18 Performance status: - ECOG 0-1 Life expectancy: - Not specified Hematopoietic: - Lymphocyte count at least 470/mm^3 - Granulocyte count at least 1,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 2.0 mg/dL* - SGOT no greater than 4 times upper limit of normal (ULN) (2.5 times ULN for adjuvant patients)* - Albumin at least 3 g/dL - No active viral hepatitis - No evidence of chronic infection due to hepatitis C - Hepatitis B surface antigen negative NOTE: *Unless due to metastatic disease Renal: - Creatinine no greater than 2.0 mg/dL Cardiovascular: - No history of cardiac failure, significant arrhythmias, or coronary artery disease (metastatic disease patients only) Other: - Not pregnant or nursing - Fertile patients must use effective contraception - HIV negative - No prior malignancy with a 50% chance of recurrence within 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix - No medical or psychiatric condition that would preclude compliance - No serious medical condition that would preclude apheresis - No serious infection - No uncontrolled thyroid disease (metastatic disease patients only) - Patients with an allergy to eggs are allowed but are not vaccinated against influenza during study PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior immunologic therapy directed at the cellular immune system Chemotherapy: - See Disease Characteristics - Prior chemotherapy for metastatic disease allowed - At least 4 weeks since prior chemotherapy - No concurrent chemotherapy or anticipated need for chemotherapy for 2 months after vaccinations Endocrine therapy: - At least 4 weeks since prior supraphysiologic steroid therapy Radiotherapy: - See Disease Characteristics - Prior radiotherapy for metastatic disease allowed - No concurrent radiotherapy Surgery: - See Disease Characteristics - Prior surgery for metastatic disease allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JohnJanik, Study Chair, Metabolism Branch
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892-1182
United States
Recruiting Patient Recruitment 1-888-NCI-1937
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center *Recruiting*
Nashville, Tennessee, 37232-6838
United States
Recruiting David Carbone 615-936-3524
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital *Recruiting*
Ft. Lauderdale, Florida, 33308
United States
Recruiting Martin Gutierrez 954-267-7700
Additional Information:
Study ID Numbers: CDR0000066874; NCI-T98-0034,NCI-99-C-0023J
Study Start Date:
Record last reviewed: December 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00019591
Other Stage 4 Colon Cancer Studies:
1. Erlotinib in Treating Patients With Recurrent or Metastatic Colorectal Cancer
2. ZD 1839 in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer That Has Not Responded to Chemotherapy
3. Chemotherapy With or Without Radiofrequency Ablation in Treating Unresectable Liver Metastases in Patients With Colorectal Cancer
4. Leucovorin and Fluorouracil With or Without SU5416 in Treating Patients With Metastatic Colorectal Cancer
5. Comparison of Combination Chemotherapy Regimens in Treating Patients With Metastatic Colorectal Cancer
Related Studies:
Other stage 4 colon cancer Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer
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