Antineoplaston Therapy in Treating Patients With Stage IV Adrenal Gland Cancer
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| ClinicalTrials.gov Identifier: NCT00003453 |
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Recruitment Status :
Terminated
(Slow enrollment)
First Posted : January 27, 2003
Results First Posted : May 9, 2018
Last Update Posted : May 9, 2018
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Current therapies for Stage IV adrenal gland cancer provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Stage IV adrenal gland cancer
PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Stage IV adrenal gland cancer.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Stage IV Adrenocortical Carcinoma | Drug: Antineoplaston therapy (Atengenal + Astugenal) | Phase 2 |
OVERVIEW: This is a single arm, open-label study in which patients with Stage IV adrenal gland cancer receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to12 months in the absence of disease progression or unacceptable toxicity.
OBJECTIVES:
- To determine the efficacy of Antineoplaston therapy in patients with Stage IV adrenal gland cancer, as measured by an objective response to therapy (complete response, partial response or stable disease).
- To determine the safety and tolerance of Antineoplaston therapy in patients with Stage IV adrenal gland cancer.
- To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 6 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Carcinoma of the Adrenal Gland |
| Study Start Date : | August 21, 1996 |
| Actual Primary Completion Date : | July 5, 2011 |
| Actual Study Completion Date : | July 5, 2011 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Antineoplaston therapy
Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
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Drug: Antineoplaston therapy (Atengenal + Astugenal)
Patients with Stage IV Adrenal Gland Cancer will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1. Other Name: A10 (Atengenal); AS2-1 (Astugenal)ANP |
- Number of Participants With Objective Response [ Time Frame: 12 months ]Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks.
- Percentage of Participants Who Survived [ Time Frame: 6 months, 12 months, 24 months, 36 months, 48 months, 60 months ]6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival
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| Ages Eligible for Study: | 6 Months to 99 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically confirmed stage IV adrenal gland carcinoma that is unlikely to respond to existing therapy and for which no curative therapy exists
- Measurable disease by MRI or CT scan
- Tumor must be greater than 2 cm at the largest diameter for the lymph nodes located in the head, neck, axillary, inguinal, or femoral areas and at least 0.5 cm in the largest diameter for other localizations
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:
- Bilirubin no greater than 2.5 mg/dL
- SGOT/SGPT no greater than 5 times upper limit of normal
- No hepatic failure
Renal:
- Creatinine no greater than 2.5 mg/dL
- No history of renal conditions that contraindicate high dosages of sodium
Cardiovascular:
- No severe heart disease
- No uncontrolled hypertension
- No history of congestive heart failure
- No history of other cardiovascular conditions that contraindicate high dosages of sodium
Pulmonary:
- No severe lung disease
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 4 weeks after study participation
- No serious active infections or fever
- No other concurrent serious disease
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
Surgery:
- Recovered from any prior operative procedure
Other:
- No prior antineoplaston therapy
- Prior cytodifferentiating agent allowed
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003453
| United States, Texas | |
| Burzynski Clinic | |
| Houston, Texas, United States, 77055-6330 | |
| Principal Investigator: | Stanislaw R. Burzynski, MD, PhD | Burzynski Research Institute |
Additional Information:
| Responsible Party: | Burzynski Research Institute |
| ClinicalTrials.gov Identifier: | NCT00003453 History of Changes |
| Other Study ID Numbers: |
CDR0000066485 BC-AD-02 ( Other Identifier: Burzynski Research Institute ) |
| First Posted: | January 27, 2003 Key Record Dates |
| Results First Posted: | May 9, 2018 |
| Last Update Posted: | May 9, 2018 |
| Last Verified: | April 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by Burzynski Research Institute:
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recurrent adrenocortical carcinoma |
Additional relevant MeSH terms:
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Carcinoma Adrenocortical Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Adrenal Cortex Neoplasms Adrenal Gland Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Adrenal Cortex Diseases Adrenal Gland Diseases Endocrine System Diseases Epinephrine Racepinephrine |
Epinephryl borate Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Adrenergic beta-Agonists Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Mydriatics Sympathomimetics |