Antineoplaston Therapy in Treating Patients With Stage IV Lung Cancer
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 stage IV lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
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 Adenocarcinoma of the Lung |
| 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 adenocarcinoma of the lung.
- Describe response to, 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 2 months in the absence of unacceptable toxicity or disease progression.
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically confirmed stage IV adenocarcinoma of the lung that is unlikely to respond to existing therapy and for which no curative therapy exists
- Measurable disease by MRI or CT scan
PATIENT CHARACTERISTICS:
Age:
- 18 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/SGPT no greater than 5 times upper limit of normal
Renal:
- Creatinine no greater than 2.5 mg/dL
- No renal insufficiency
- No history of renal conditions that contraindicate high dosages of sodium
Cardiovascular:
- No chronic heart disease that would preclude study treatment
- No history of chronic heart failure
- No uncontrolled hypertension
- No history of congestive heart failure
- No history of cardiovascular conditions that contraindicate high dosages of sodium
Pulmonary:
- No lung disease that would preclude study treatment
- No serious lung disease (e.g., severe chronic obstructive pulmonary disease)
Neurologic:
- No neurological disease that would preclude study treatment
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 4 weeks after study participation
- No gastrointestinal or psychiatric disease that would preclude study treatment
- No active infection
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since prior immunotherapy and recovered
- No concurrent immunomodulatory 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:
- Not specified
Other:
- Prior cytodifferentiating agents allowed
- No prior antineoplaston therapy
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: | NCT00003491 History of Changes |
| Other Study ID Numbers: | CDR0000066530, BC-LA-3 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent non-small cell lung cancer stage IV non-small cell lung cancer adenocarcinoma of the lung |
Additional relevant MeSH terms:
|
Adenocarcinoma Lung Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on June 18, 2013