|
|
Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Stage IV Adrenal Gland Carcinoma
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outcomes Outline Trial Contact Information Registry Information
Alternate Title
Antineoplaston Therapy in Treating Patients With Stage
IV Adrenal Gland Cancer
Basic Trial Information
Phase | Type | Status | Age | Protocol IDs |
---|
Phase II | Treatment | Active | 6 months and over | BC-AD-2 NCT00003453 |
Objectives - Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with stage IV adrenal gland carcinoma.
- Determine the tolerance to and side effects of this regimen in these patients.
- Determine the response in patients treated with this regimen.
Entry Criteria Disease Characteristics:
- Histologically confirmed stage IV adrenal gland carcinoma that is
unlikely to
respond to existing therapy and for which no curative therapy exists
- Measurable disease by MRI or CT scan
- Tumor must be greater than 2 cm at the largest diameter for the lymph
nodes
located in the head, neck, axillary, inguinal, or femoral areas and at
least
0.5 cm in the largest diameter for other localizations
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
Surgery: - Recovered from any prior operative procedure
Other: - No prior antineoplaston therapy
- Prior cytodifferentiating agent allowed
Patient Characteristics:
Age: Performance status: Life expectancy: Hematopoietic: - WBC at least 2,000/mm3
- Platelet count at least 50,000/mm3
Hepatic: - Bilirubin no greater than 2.5 mg/dL
- SGOT/SGPT no greater than 5 times upper limit of
normal
- No hepatic failure
Renal: - Creatinine no greater than 2.5 mg/dL
- No history of renal conditions that contraindicate high
dosages of sodium
Cardiovascular: - No severe heart disease
- No uncontrolled hypertension
- No history of congestive heart failure
- No history of other cardiovascular conditions that
contraindicate high dosages of sodium
Pulmonary: Other: - Not pregnant or nursing
- Fertile patients must use effective contraception during and
for 4 weeks after study participation
- No serious active infections or fever
- No other concurrent serious disease
Expected Enrollment 40A total of 20-40 patients will be accrued for this study. Outcomes Primary Outcome(s)Response rate based on tumor measurements at 12 weeks
Secondary Outcome(s)Survival at 1, 2, and 5 years from the start of treatment
Outline Patients receive gradually escalating doses of antineoplaston A10 and
antineoplaston AS2-1 IV over a minimum of 1 hour 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. Patients are followed every 2 months for the first year and then every
3 months for the second year.
Trial Contact Information
Trial Lead Organizations Burzynski Clinic | | | Stanislaw Burzynski, MD, PhD, Protocol chair | | | | Trial Sites
Registry Information | | Official Title | | Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Carcinoma of the Adrenal Gland | | Trial Start Date | | 1996-08-21 | | Trial Completion Date | | 2011-12-31 (estimated) | | Registered in ClinicalTrials.gov | | NCT00003453 | | Date Submitted to PDQ | | 1998-07-29 | | Information Last Verified | | 2008-12-21 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
|