|
Antineoplaston Therapy in Treating Patients With Metastatic, Recurrent, or Refractory Neuroblastoma Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Antineoplaston Therapy in Treating Patients With Metastatic, Recurrent, or Refractory Neuroblastoma conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Antineoplaston Therapy in Treating Patients With Metastatic, Recurrent, or Refractory Neuroblastoma Clinical research trials and Antineoplaston Therapy in Treating Patients With Metastatic, Recurrent, or Refractory Neuroblastoma medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Antineoplaston Therapy in Treating Patients With Metastatic, Recurrent, or Refractory Neuroblastoma. Antineoplaston Therapy in Treating Patients With Metastatic, Recurrent, or Refractory Neuroblastoma Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Antineoplaston Therapy in Treating Patients With Metastatic, Recurrent, or Refractory Neuroblastoma clinical trial. Subjects often receive the most expert healthcare possible for their Antineoplaston Therapy in Treating Patients With Metastatic, Recurrent, or Refractory Neuroblastoma condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "A" Clinical Trials Conditions > Antineoplaston Therapy in Treating Patients With Metastatic, Recurrent, or Refractory Neuroblastoma  Antineoplaston Therapy in Treating Patients With Metastatic, Recurrent, or Refractory Neuroblastoma
Antineoplaston Therapy in Treating Patients With Metastatic, Recurrent, or Refractory Neuroblastoma
For Condition: disseminated neuroblastoma,recurrent neuroblastoma,stage 4S neuroblastoma,regional neuroblastoma,localized unresectable neuroblastoma
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 metastatic, recurrent, or refractoryneuroblastoma.
Details: OBJECTIVES: - Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with metastatic, recurrent, or refractory neuroblastoma. - 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 antineoplaston A10 and antineoplaston AS2-1 by intravenous injection 6 times a day until the maximum tolerated dose is reached. Treatment continues for at least 2 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 incurable neuroblastoma that is unlikely to respond to existing therapy, meeting 1 of the following criteria: - Metastatic disease - Progressive, recurrent, or persistent disease after initial therapy, including surgery, chemotherapy, and/or radiotherapy - Measurable disease by MRI or CT scan - Tumor must be at least 2 cm 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 a high medical or psychiatric risk PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior immunotherapy - No concurrent immunomodulating agents Chemotherapy: - See Disease Characteristics - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) Endocrine therapy: - Concurrent corticosteroids allowed Radiotherapy: - See Disease Characteristics - At least 8 weeks since prior radiotherapy Surgery: - See Disease Characteristics - 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: CDR0000066556; BC-NB-2
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003513
Other Regional Neuroblastoma Studies:
1. Pyrazoloacridine and Stem Cell or Bone Marrow Transplantation in Treating Young Patients With Recurrent or Refractory Neuroblastoma
2. Radiation Therapy, Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Primitive Neuroectodermal Tumors
3. Isotretinoin With or Without Monoclonal Antibody, Interleukin 2, and Sargramostim Following Stem Cell Transplantation in Treating Patients With Neuroblastoma
4. Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Neuroblastoma
5. Induction Chemotherapy Using Cyclophosphamide and Topotecan in Treating Patients Who Are Undergoing Autologous Peripheral Stem Cell Transplantation for Newly Diagnosed or Progressive Neuroblastoma
Related Studies:
Other regional neuroblastoma Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Antineoplaston Therapy in Treating Patients With Metastatic, Recurrent, or Refractory Neuroblastoma
|
|
|
|
|
|
|
|
