Antineoplaston Therapy in Treating Patients With Neuroendocrine Tumor That Is Metastatic or Unlikely to Respond to Surgery or Radiation Therapy - Article
Clinical Trial: Antineoplaston Therapy in Treating Patients With Neuroendocrine Tumor That Is Metastatic or Unlikely to Respond to Surgery or Radiation Therapy
This study is currently recruiting patients.
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 is studying how well antineoplaston therapy works in treating patients with neuroendocrine tumor that is metastatic or unlikely to respond to surgery or radiation therapy.
|Condition||Treatment or Intervention||Phase|
|Merkel Cell Carcinoma |
Islet Cell Carcinoma
| Drug: antineoplaston A10 |
Drug: antineoplaston AS2-1
Procedure: alternative product therapy
Procedure: biological response modifier therapy
Procedure: biologically based therapies
Procedure: cancer prevention intervention
Procedure: complementary and alternative therapy
Procedure: differentiation therapy
|Phase II |
MedlinePlus related topics: Brain Cancer; Brain Diseases; Cancer; Cancer Alternative Therapy; Endocrine Diseases; Pancreatic Cancer; Pituitary Disorders; Skin Cancer
Study Type: Interventional
Study Design: Treatment
- Provide treatment with antineoplastons A10 and AS2-1 for patients with metastatic or incurable neuroendocrine tumors.
- Describe response, tolerance to, and side effects of this regimen in these patients.
OUTLINE: This is an open-label study.
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.
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
- Histologically confirmed incurable neuroendocrine tumor that is unlikely to respond to existing therapy, meeting 1 of the following criteria:
- Metastatic disease
- Disease that is not curable with surgery or radiotherapy
- Measurable disease by MRI or CT scan
- Tumor must be at least 2 cm
PATIENT CHARACTERISTICS: Age:
- 18 and over
- Karnofsky 60-100%
- At least 2 months
- WBC at least 2,000/mm^3
- Platelet count at least 50,000/mm^3
- No hepatic insufficiency
- Bilirubin no greater than 2.5 mg/dL
- SGOT and SGPT no greater than 5 times upper limit of normal
- No renal insufficiency
- Creatinine no greater than 2.5 mg/dL
- No history of renal conditions that contraindicate high dosages of sodium
- No uncontrolled hypertension
- No history of congestive heart failure
- No history of other cardiovascular conditions that contraindicate high dosages of sodium
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 4 weeks after study participation
- No active infection
- No concurrent 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
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
- Concurrent corticosteroids allowed
- At least 8 weeks since prior radiotherapy
- Recovered from prior surgery
- Prior cytodifferentiating agents allowed
- No prior antineoplastons
- No other concurrent antineoplastic agents
Location and Contact Information
Burzynski Clinic, Houston, Texas, 77055-6330, United States; Recruiting
Stanislaw R. Burzynski, MD, PhD, Study Chair, Burzynski Research Institute
Record last reviewed: October 2003
Last Updated: February 7, 2005
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00003514
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Cache Date: April 9, 2005
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