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Monoclonal Antibody Therapy in Treating Patients With Lymphoma, Colon Cancer, or Prostate Cancer That Has Not Responded to Vaccine Therapy Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Monoclonal Antibody Therapy in Treating Patients With Lymphoma, Colon Cancer, or Prostate Cancer That Has Not Responded to Vaccine Therapy conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Monoclonal Antibody Therapy in Treating Patients With Lymphoma, Colon Cancer, or Prostate Cancer That Has Not Responded to Vaccine Therapy Clinical research trials and Monoclonal Antibody Therapy in Treating Patients With Lymphoma, Colon Cancer, or Prostate Cancer That Has Not Responded to Vaccine Therapy healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Monoclonal Antibody Therapy in Treating Patients With Lymphoma, Colon Cancer, or Prostate Cancer That Has Not Responded to Vaccine Therapy. Monoclonal Antibody Therapy in Treating Patients With Lymphoma, Colon Cancer, or Prostate Cancer That Has Not Responded to Vaccine Therapy Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Monoclonal Antibody Therapy in Treating Patients With Lymphoma, Colon Cancer, or Prostate Cancer That Has Not Responded to Vaccine Therapy clinical trial. Human subjects often receive the most effective healthcare possible for their Monoclonal Antibody Therapy in Treating Patients With Lymphoma, Colon Cancer, or Prostate Cancer That Has Not Responded to Vaccine Therapy condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "M" Clinical Trials Conditions > Monoclonal Antibody Therapy in Treating Patients With Lymphoma, Colon Cancer, or Prostate Cancer That Has Not Responded to Vaccine Therapy  Monoclonal Antibody Therapy in Treating Patients With Lymphoma, Colon Cancer, or Prostate Cancer That Has Not Responded to Vaccine Therapy
Monoclonal Antibody Therapy in Treating Patients With Lymphoma, Colon Cancer, or Prostate Cancer That Has Not Responded to Vaccine Therapy
For Condition: recurrent grade 3 follicular lymphoma,recurrent mantle cell lymphoma,recurrent colon cancer,recurrent grade 1 follicular lymphoma,recurrent grade 2 follicular lymphoma,recurrent prostate cancer
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: RATIONALE: Monoclonal antibodies such as anti-cytotoxic T-lymphocyte-associated antigen-4 can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody in treating patients who have lymphoma, colon cancer, or prostate cancer that has not responded to vaccine therapy.
Details: OBJECTIVES: - Determine the toxicity of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody in patients with follicular or mantle cell lymphoma, colon cancer, or prostate cancer refractory to vaccine therapy. - Determine the ability of this drug to increase tumor-specific T-cell responses in these patients. - Determine the ability of this drug to produce clinical tumor response in these patients. - Determine the effect of this drug on suppressor T-cell populations (CD4+ and CD25+ cells) in these patients. OUTLINE: Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody IV over 90 minutes on day 1. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every other month. PROJECTED ACCRUAL: A maximum of 12 patients (4 per tumor type) will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed prostate cancer - Prior therapy on protocol NCI-00-C-0137 or NCI-00-C-0154 - Progressive disease (2 consecutively rising PSA levels, new bone scan lesion, or progression of soft tissue) - PSA at least 5 ng/mL - Progressive androgen-independent disease - Disease progression at least 4 weeks after flutamide withdrawal OR - Disease progression at least 6 weeks after bicalutamide or nilutamide withdrawal - Prior intervening therapy allowed OR - Histologically confirmed follicular or mantle cell non-Hodgkin's lymphoma - Prior therapy on protocol NCI-00-C-0133, NCI-01-C-0169, or NCI-00-C-0050 - Progressive disease OR - Histologically confirmed colon cancer - Prior therapy on protocol NCI-99-C-0023 - Progressive disease - Must have received prior vaccine therapy within the past 14 months on a protocol involving one of the following vaccines: - Mutant ras peptide-pulsed dendritic cell vaccine - Idiotype lymphoma vaccine - Vaccinia prostate vaccine - No other standard therapy available or refused such therapy - No symptomatic or rapidly progressive malignancy requiring therapy - No symptomatic CNS metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 80-100% Life expectancy - More than 2 months Hematopoietic - WBC at least 2,500/mm^3 - Granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10 g/dL - Hematocrit at least 30% Hepatic - Bilirubin no greater than 3.0 mg/dL (unless due to Gilbert's disease) - SGOT and SGPT no greater than 3 times upper limit of normal - Hepatitis B surface antigen negative - Hepatitis C antibody negative Renal - Creatinine no greater than 2.0 mg/dL Immunologic - HIV negative - Rheumatoid factor negative if history or evidence of arthritis - Anti-nuclear antibody (ANA) titer no greater than 1:80 if history or clinical signs or symptoms of connective tissue disease - No prior or active autoimmune disease (e.g., uveitis, rheumatoid arthritis, or lupus erythematosus) - No positive antibody titers to autoimmune diseases - Rheumatoid factor positive allowed unless ANA titer is greater than 1:80 and there is a history of or clinical signs or symptoms of connective tissue disease - No active infection Other - No other active malignancy within the past 5 years except adequately treated squamous cell or basal cell skin cancer, carcinoma in situ of the cervix, or superficial bladder cancer - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 4 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - Recovered from prior vaccine therapy - No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody - No concurrent vaccine therapy - No concurrent infliximab - No concurrent immunomodulatory drugs Chemotherapy - At least 4 weeks since prior cytotoxic chemotherapy - No concurrent mercaptopurine, methotrexate, or cyclophosphamide Endocrine therapy - See Disease Characteristics - At least 4 weeks since prior steroids - No concurrent systemic, inhaled, or topical steroids Radiotherapy - At least 4 weeks since prior radiotherapy Surgery - At least 4 weeks since prior major surgery Other - No other concurrent investigational therapy - No other concurrent immunosuppressants (e.g., cyclosporine or its analog) - No other concurrent anti-proliferative drugs
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 888-NCI-1937
Additional Information:
Study ID Numbers: CDR0000257563; NCI-02-C-0284,NCI-5744
Study Start Date:
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00047164
Other Recurrent Colon Cancer Studies:
1. ZD 1839 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
2. Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer
3. Combination Chemotherapy in Treating Pain in Patients With Hormone Refractory Metastatic Prostate Cancer
4. Combination Chemotherapy Plus Filgrastim in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy
5. Arsenic Trioxide in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Previous Hormone Therapy
Related Studies:
Other recurrent colon cancer Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Monoclonal Antibody Therapy in Treating Patients With Lymphoma, Colon Cancer, or Prostate Cancer That Has Not Responded to Vaccine Therapy
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