Antineoplaston Therapy in Treating Patients With Stage IV Adrenal Gland Cancer

• ClinicalTrials.gov Identifier: NCT00003453
• Recruitment Status: Terminated
• First Posted: January 27, 2003
• Results First Posted: May 9, 2018
• Last Update Posted: May 9, 2018
• Sponsor: Burzynski Research Institute
• Information provided by (Responsible Party): Burzynski Research Institute

Study Description

Brief Summary:

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

Detailed Description:

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 6 participants
• Allocation: N/A
• 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

Arms and Interventions

Arm

Intervention/treatment

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.

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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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

Eligibility Criteria

• Ages Eligible for Study: 6 Months to 99 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Texas

Burzynski Clinic

Houston, Texas, United States, 77055-6330

Sponsors and Collaborators

Burzynski Research Institute

Investigators

• Principal Investigator: Stanislaw R. Burzynski, MD, PhD; Burzynski Research Institute

More Information

Additional Information:

Burzynski Research Institute 

Burzynski Clinic 

• Responsible Party: Burzynski Research Institute
• ClinicalTrials.gov Identifier: NCT00003453
• Other Study ID Numbers: CDR0000066485; BC-AD-02 ( Other Identifier: Burzynski Research Institute )
• First Posted: January 27, 2003
• 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:

recurrent adrenocortical carcinoma

Additional relevant MeSH terms:

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