Antineoplaston Therapy in Treating Patients With Residual or Recurrent Anaplastic Astrocytoma
Recruitment status was 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 is studying how well antineoplaston therapy works in treating patients with residual or recurrent anaplastic astrocytoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
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 Anaplastic Astrocytoma |
- Response rate assessed by tumor measurements at 12 weeks [ Designated as safety issue: No ]
- Survival at 1, 2, and 5 years from the start of treatment [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | April 1995 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine the objective response rate in patients with anaplastic astrocytoma treated with antineoplastons A10 and AS2-1 after subtotal resection.
- Assess 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 IV 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. Patients achieving stable disease or partial response may continue treatment. Patients achieving complete response (CR) continue treatment for an additional 8 months after CR.
Tumors are measured at 1 month, every 1-2 months for 2 years, every 3 months for the third year, every 4 months for the fourth year, every 6 months for the fifth year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 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 or cytologically confirmed anaplastic astrocytoma
- Tumor subtotally resected or biopsied
- Radiologic evidence of residual or recurrent tumor by gadolinium-enhanced MRI, CT scan, or positron-emission tomography
- No brain stem tumors
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- More than 2 months
Hematopoietic:
- WBC at least 1,500/mm^3
- Platelet count at least 50,000/mm^3
- Hemoglobin at least 10 g/dL
Hepatic:
- Bilirubin no greater than 2.5 mg/dL
- SGOT and SGPT no greater than 5 times upper limit of normal
- No hepatic failure
Renal:
- Creatinine no greater than 2.5 mg/dL
- No renal failure
Cardiovascular:
- No prior congestive heart failure
- No coronary artery disease
- No myocardial infarction within the past year
- No angina requiring medication
- No uncontrolled hypertension
Pulmonary:
- No moderate to severe 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 other concurrent serious disease
- No other prior malignancy except carcinoma in situ of the cervix or superficial nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior immunotherapy
- No concurrent immunomodulating agents
Chemotherapy:
- No prior myelosuppressive chemotherapy
Endocrine therapy:
- Concurrent corticosteroids for cerebral edema allowed
Radiotherapy:
- No prior myelosuppressive radiotherapy
- No concurrent radiotherapy
Surgery:
- See Disease Characteristics
- Recovered from any prior surgery
Other:
- No prior cytodifferentiating agents
- No prior antineoplaston therapy
- No other concurrent antineoplastic agents
Contacts and Locations| United States, Texas | |
| Burzynski Clinic | Recruiting |
| Houston, Texas, United States, 77055-6330 | |
| Contact: Stanislaw R. Burzynski, MD, PhD 713-335-5697 info@burzynskiclinic.com | |
| Study Chair: | Stanislaw R. Burzynski, MD, PhD | Burzynski Research Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | Stanislaw R. Burzynski, Burzynski Clinic |
| ClinicalTrials.gov Identifier: | NCT00003537 History of Changes |
| Other Study ID Numbers: | CDR0000066585, BC-BT-8 |
| Study First Received: | November 1, 1999 |
| Last Updated: | June 9, 2009 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
recurrent adult brain tumor adult anaplastic astrocytoma |
Additional relevant MeSH terms:
|
Astrocytoma Nervous System Neoplasms Central Nervous System Neoplasms Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013