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Home > "A" Clinical Trials Conditions > Antineoplaston Therapy in Treating Patients With Stage IV Kidney Cancer  Antineoplaston Therapy in Treating Patients With Stage IV Kidney Cancer
Antineoplaston Therapy in Treating Patients With Stage IV Kidney Cancer
For Condition: stage 4 renal cell cancer,recurrent transitional cell cancer of the renal pelvis and ureter,recurrent renal cell cancer,Renal Cell Adenocarcinoma,metastatic transitional cell cancer of the renal pelvis and ureter
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 stage IV kidney cancer.
Details: OBJECTIVES: - Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with incurable carcinoma of the kidney. - Describe response to, 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 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 achieving CR. Tumors are measured every 2 months for 1 year and every 3 months for 1 year. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed stage IV adenocarcinoma or transitional cell carcinoma of the kidney that is unlikely to respond to existing therapy - Measurable disease by MRI or CT scan - Tumor must be more than 2 cm for lymph nodes in head, neck, axillary, inguinal, or femoral areas and at least 0.5 cm for other locations PATIENT CHARACTERISTICS: Age: - 18 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/mL - No history of renal conditions that contraindicate high dosages of sodium Cardiovascular: - No known chronic heart failure - No uncontrolled hypertension - No history of congestive heart failure - No history of other cardiovascular conditions that contraindicate high dosages of sodium Pulmonary: - No severe 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 - Not a high medical or psychiatric risk - No concurrent nonmalignant systemic disease that would preclude therapy - No active infection PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior immunotherapy - No concurrent immunomodulatory agents Chemotherapy: - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered - No concurrent antineoplastic agents Endocrine therapy: - Concurrent corticosteroids allowed Radiotherapy: - At least 8 weeks since prior radiotherapy and recovered Surgery: - Recovered from prior surgery Other: - Prior cytodifferentiating agents allowed - No prior antineoplastons
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: CDR0000066564; BC-RN-2
Study Start Date:
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003520
Other Metastatic Transitional Cell Cancer Of The Renal Pelvis And Ureter Studies:
1. Interleukin-12 and Interferon alfa in Treating Patients With Metastatic Kidney Cancer or Malignant Melanoma
2. Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic or Unresectable Kidney Cancer
3. UCN-01 in Treating Patients With Advanced or Metastatic Kidney Cancer
4. Interleukin-2 in Treating Patients With Stage III or Stage IV Kidney Cancer
5. Tretinoin Plus Interferon alfa in Treating Patients With Metastatic Kidney Cancer
Related Studies:
Other metastatic transitional cell cancer of the renal pelvis and ureter Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Antineoplaston Therapy in Treating Patients With Stage IV Kidney Cancer
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