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Antineoplaston Therapy in Treating Patients With Soft Tissue Sarcoma Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Antineoplaston Therapy in Treating Patients With Soft Tissue Sarcoma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Antineoplaston Therapy in Treating Patients With Soft Tissue Sarcoma Clinical research trials and Antineoplaston Therapy in Treating Patients With Soft Tissue Sarcoma health trials occur in a lot of 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 potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Antineoplaston Therapy in Treating Patients With Soft Tissue Sarcoma. Antineoplaston Therapy in Treating Patients With Soft Tissue Sarcoma Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Antineoplaston Therapy in Treating Patients With Soft Tissue Sarcoma clinical trial. Human subjects often get the best healthcare possible for their Antineoplaston Therapy in Treating Patients With Soft Tissue Sarcoma condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > Antineoplaston Therapy in Treating Patients With Soft Tissue Sarcoma  Antineoplaston Therapy in Treating Patients With Soft Tissue Sarcoma
Antineoplaston Therapy in Treating Patients With Soft Tissue Sarcoma
For Condition: recurrent childhood soft tissue sarcoma,stage 3 adult soft tissue sarcoma,recurrent adult soft tissue sarcoma,nonmetastatic childhood soft tissue sarcoma,stage 4 adult soft tissue sarcoma,metastatic childhood soft tissue sarcoma
Status: Recruiting
Sponsor(s): Burzynski Research Institute ,
Synopsis: RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the laboratory. Antineoplastons may inhibit the growth of cancer cells. PURPOSE: This phase II trial studies the effectiveness of antineoplaston therapy in treating patients who have soft tissuesarcoma.
Details: OBJECTIVES: - Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with incurable soft tissue sarcoma. - Describe response, tolerance to, and side effects of this regimen in these patients. OUTLINE: This is an open-label study. Patients receive gradually escalating doses of antineoplastons A10 and AS2-1 by intravenous injection 6 times daily until the maximum tolerated dose is reached. Treatment continues for at least 3 months in the absence of unacceptable toxicity or disease progression. Patients achieving complete response (CR) continue treatment for an additional 8 months after reaching CR. Tumors are measured every 2 months for 1 year and then every 3 months for 1 year. PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed soft tissue sarcoma that is unlikely to respond to existing therapy, including surgery, radiotherapy, and chemotherapy - Evidence of tumor by MRI, CT scan, chest x-ray, or radionuclide scan PATIENT CHARACTERISTICS: Age: - 6 months and over Performance status: - Karnofsky 60-100% Life expectancy: - At least 2 months Hematopoietic: - WBC at least 2,000/mm^3 - Platelet count at least 50,000/mm^3 Hepatic: - No hepatic insufficiency - Bilirubin no greater than 2.5 mg/dL - SGOT and SGPT no greater than 5 times upper limit of normal Renal: - No renal insufficiency - Creatinine no greater than 2.5 mg/dL - No history of renal conditions that contraindicate high dosages of sodium Cardiovascular: - No uncontrolled hypertension - No history of congestive heart failure - No history of other cardiovascular conditions that contraindicate high dosages of sodium Pulmonary: - No serious lung disease, such as chronic obstructive pulmonary disease Other: - Not pregnant or nursing - Fertile patients must use effective contraception during and for 4 weeks after study participation - No active infection - No nonmalignant systemic disease - Not high medical or psychiatric risk PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since immunotherapy - No concurrent immunomodulating agents Chemotherapy: - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) Endocrine therapy: - Concurrent corticosteroids allowed Radiotherapy: - At least 8 weeks since prior radiotherapy Surgery: - Recovered from prior surgery Other: - Prior cytodifferentiating agents allowed - No prior antineoplastons - No other concurrent antineoplastic agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StanislawBurzynski, Study Chair, Burzynski Research Institute
Burzynski Clinic *Recruiting*
Houston, Texas, 77055-6330
United States
Recruiting Stanislaw Burzynski 713-335-5697
Additional Information:
Study ID Numbers: CDR0000066565; BC-SA-2
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003521
Other Recurrent Adult Soft Tissue Sarcoma Studies:
1. CP4071 in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma
2. Combination Chemotherapy, Peripheral Stem Cell Transplantation, and Radiation Therapy in Treating Patients With Ewing's Sarcoma, Peripheral Primitive Neuroectodermal Tumor, or Rhabdomyosarcoma
3. Whole-Body Hyperthermia Plus Chemotherapy in Treating Patients With Advanced Sarcoma
4. Chemotherapy, SU5416, Radiation Therapy, and Surgery in Treating Patients With Soft Tissue Sarcoma
5. Antineoplaston Therapy in Treating Patients With Soft Tissue Sarcoma
Related Studies:
Other recurrent adult soft tissue sarcoma Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Antineoplaston Therapy in Treating Patients With Soft Tissue Sarcoma
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