Antineoplaston Therapy in Treating Patients With Soft Tissue Sarcoma
Recruitment status was Active, not recruiting
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Purpose
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 soft tissue sarcoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Sarcoma |
Drug: antineoplaston A10 Drug: antineoplaston AS2-1 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Soft Tissue Sarcoma |
| Estimated Enrollment: | 40 |
| Study Start Date: | August 1998 |
OBJECTIVES:
- Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with incurable soft tissue sarcoma.
- 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 antineoplastons A10 and 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 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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed soft tissue sarcoma that is unlikely to respond to existing therapy, including surgery, radiotherapy, and chemotherapy
- Evidence of tumor by MRI, CT scan, chest x-ray, or radionuclide scan
PATIENT CHARACTERISTICS:
Age:
- 6 months 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/dL
- No history of renal conditions that contraindicate high dosages of sodium
Cardiovascular:
- No uncontrolled hypertension
- No history of congestive heart failure
- No history of other cardiovascular conditions that contraindicate high dosages of sodium
Pulmonary:
- No serious 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
- No active infection
- No nonmalignant systemic disease
- Not high medical or psychiatric risk
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since immunotherapy
- No concurrent immunomodulating agents
Chemotherapy:
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
Endocrine therapy:
- Concurrent corticosteroids allowed
Radiotherapy:
- At least 8 weeks since prior radiotherapy
Surgery:
- Recovered from prior surgery
Other:
- Prior cytodifferentiating agents allowed
- No prior antineoplastons
- No other concurrent antineoplastic agents
Contacts and Locations| United States, Texas | |
| Burzynski Clinic | |
| Houston, Texas, United States, 77055-6330 | |
| Study Chair: | Stanislaw R. Burzynski, MD, PhD | Burzynski Research Institute |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00003521 History of Changes |
| Other Study ID Numbers: | CDR0000066565, BC-SA-2 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage III adult soft tissue sarcoma stage IV adult soft tissue sarcoma recurrent adult soft tissue sarcoma |
nonmetastatic childhood soft tissue sarcoma metastatic childhood soft tissue sarcoma recurrent childhood soft tissue sarcoma |
Additional relevant MeSH terms:
|
Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms |
ClinicalTrials.gov processed this record on May 16, 2013