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Home > "A" Clinical Trials Conditions > Antineoplaston Therapy in Treating Patients With Stage IV Melanoma  Antineoplaston Therapy in Treating Patients With Stage IV Melanoma
Antineoplaston Therapy in Treating Patients With Stage IV Melanoma
For Condition: Recurrent Melanoma,Stage 4 Melanoma
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 progressive or recurrentstage IV melanoma.
Details: OBJECTIVES: - Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with progressive or recurrent stage IV melanoma. - 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 daily until the maximum tolerated dose is reached. Treatment continues for at least 3 months in the absence of toxicity and disease progression. Patients achieving complete response (CR) continue treatment for an additional 8 months after reaching CR. Tumors are measured every 2 months for the first year and every 3 months for the second 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 melanoma that is recurrent or progressing and unlikely to respond to existing therapy - Measurable disease by MRI or CT scan - Tumor must be at least 2 cm in the lymph nodes in the head, neck, axillary, inguinal, or femoral areas and at least 0.5 cm in 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/mm3 - Platelet count at least 50,000/mm3 Hepatic: - Bilirubin no greater than 2.5 mg/dL - SGOT and SGPT no greater than 5 times the upper limit of normal - No hepatic insufficiency Renal: - Creatinine no greater than 2.5 mg/dL - No renal insufficiency - No renal conditions that contraindicate high dosages of sodium Cardiovascular: - No chronic heart failure - No uncontrolled hypertension - No history of congestive heart failure - No 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 - No serious medical or psychiatric disorders - No active infection PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior immunotherapy and recovered - No concurrent immunomodulating 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 (patients with multiple tumors who have received radiotherapy to some, but not all, tumors may be admitted earlier than 8 weeks) Surgery: - Recovered from prior surgery Other: - Prior cytodifferentiating agent allowed - No prior antineoplaston therapy
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: CDR0000066552; BC-ME-2
Study Start Date:
Record last reviewed: December 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003509
Other Stage 4 Melanoma Studies:
1. Vaccine Therapy in Treating Patients With Stage IV Melanoma
2. Biological Therapy in Treating Patients With Metastatic Melanoma or Metastatic Kidney Cancer
3. Antineoplaston Therapy in Treating Patients With Stage IV Melanoma
4. Vaccine Therapy in Treating Patients With Unresectable Metastatic Melanoma
5. Boron Neutron Capture Therapy in Treating Patients With Melanoma
Related Studies:
Other Stage 4 Melanoma Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Antineoplaston Therapy in Treating Patients With Stage IV Melanoma
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