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Vaccine Therapy and Sargramostim in Treating Patients With Soft Tissue Sarcoma Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Vaccine Therapy and Sargramostim in Treating Patients With Soft Tissue Sarcoma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Vaccine Therapy and Sargramostim in Treating Patients With Soft Tissue Sarcoma Clinical research trials and Vaccine Therapy and Sargramostim in Treating Patients With Soft Tissue Sarcoma healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Vaccine Therapy and Sargramostim in Treating Patients With Soft Tissue Sarcoma. Vaccine Therapy and Sargramostim in Treating Patients With Soft Tissue Sarcoma Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Vaccine Therapy and Sargramostim in Treating Patients With Soft Tissue Sarcoma clinical trial. Human subjects often obtain the finest healthcare possible for their Vaccine Therapy and Sargramostim in Treating Patients With Soft Tissue Sarcoma condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "V" Clinical Trials Conditions > Vaccine Therapy and Sargramostim in Treating Patients With Soft Tissue Sarcoma  Vaccine Therapy and Sargramostim in Treating Patients With Soft Tissue Sarcoma
Vaccine Therapy and Sargramostim in Treating Patients With Soft Tissue Sarcoma
For Condition: adult synovial sarcoma,adult soft tissue sarcoma
Status: No longer recruiting
Sponsor(s): Herbert Irving Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: 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 or peripheral blood. Combining vaccine therapy with sargramostim may be effective in treating soft tissue sarcoma. PURPOSE: Phase I trial to study the effectiveness of combining vaccine therapy with sargramostim in treating patients who have stage II, stage III, or stage IV soft tissue sarcoma.
Details: OBJECTIVES: - Determine the safety and tolerability of NY-ESO-1 peptide vaccine and sargramostim (GM-CSF) in patients with stage II, III, or IV soft tissue sarcoma expressing NY-ESO-1 or LAGE antigen. - Determine the immunologic profile (NY-ESO-1 antibody, CD8+ cells, and delayed-type hypersensitivity) in patients treated with this regimen. - Determine tumor responses in patients treated with this regimen. OUTLINE: Patients receive NY-ESO-1 peptide vaccine intradermally once every 2 weeks for a total of 6 vaccinations. Patients also receive sargramostim (GM-CSF) subcutaneously once daily beginning 2 days before every vaccination and continuing for 5 days. Treatment continues in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study within 12 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed high-risk stage II, III, or IV soft tissue sarcoma expressing NY-ESO-1 or LAGE antigen (including, but not limited to, synovial sarcoma) - HLA-A2 allele for NY-ESO-1 peptides - Declined, failed, or completed standard therapy - CNS metastases allowed if treated and stable PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Not specified Life expectancy: - At least 3 months Hematopoietic: - Hemoglobin at least 9.0 g/dL - Lymphocyte count at least 500/mm3 - Platelet count at least 100,000/mm3 - No bleeding disorders Hepatic: - Bilirubin no greater than 2 mg/dL - Hepatitis B and C negative Renal: - Creatinine no greater than 1.8 mg/dL Cardiovascular: - No New York Heart Association class III or IV heart disease Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative - No other serious illness (e.g., serious infection requiring antibiotics) - No immunodeficiency disease - No psychiatric or addictive disorders that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior bone marrow or peripheral blood stem cell transplantation - At least 4 weeks since prior immunotherapy Chemotherapy: - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) - No concurrent chemotherapy Endocrine therapy: - No concurrent steroids except topical or inhaled steroids - Concurrent noncytotoxic anticancer hormonal therapy allowed (e.g., hormones for breast or prostate cancer) Radiotherapy: - At least 4 weeks since prior radiotherapy Surgery: - At least 4 weeks since prior surgery Other: - At least 4 weeks since prior participation in any other clinical trial involving another investigational agent - No concurrent antihistamines - No concurrent non-steroidal anti-inflammatory drugs except low doses for prevention of an acute cardiovascular event or pain control - No concurrent immunosuppressive agents - Concurrent noncytotoxic anticancer therapy allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
KyriakosPapadopoulos, Study Chair, Columbia Presbyterian Medical Center
Herbert Irving Comprehensive Cancer Center at Columbia University
New York City, New York, 10032
United States
Additional Information:
Study ID Numbers: CDR0000069092; CPMC-IRB-13578,NCI-G01-2035,LUDWIG-LUD00-024
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00027911
Other Adult Soft Tissue Sarcoma Studies:
1. Vaccine Therapy and Sargramostim in Treating Patients With Soft Tissue Sarcoma
2. STI571 in Treating Patients With Recurrent or Refractory Soft Tissue Sarcoma
3. Temozolomide and Thalidomide in Treating Patients With Metastatic, Locally Advanced, or Unresectable Leiomyosarcoma
4. Gemcitabine, Docetaxel, and Filgrastim in Treating Patients With Recurrent or Persistent Leiomyosarcoma or Soft Tissue Sarcoma
5. Bortezomib in Treating Patients With Advanced or Metastatic Sarcoma
Related Studies:
Other adult soft tissue sarcoma Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Vaccine Therapy and Sargramostim in Treating Patients With Soft Tissue Sarcoma
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