Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Malignant Melanoma
18 Years
N/A
Both
Melanoma (Skin)
Trial Information
Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Malignant Melanoma
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate based on tumor measurements at 12 weeks
Safety Issue:
No
Principal Investigator
Stanislaw R. Burzynski, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Burzynski Research Institute
Authority:
United States: Federal Government
Study ID:
CDR0000066552
NCT ID:
NCT00003509
Start Date:
March 1996
Completion Date:
Related Keywords:
- Melanoma (Skin)
- stage IV melanoma
- recurrent melanoma
- Melanoma
Name | Location |
|---|---|
| Burzynski Clinic | Houston, Texas 77055-6330 |
