Antineoplaston Therapy In Treating Patients With Neuroendocrine Tumor That Is Metastatic Or Unlikely To Respond To Surgery Or Radiation Therapy

Study Overview

Antineoplaston Therapy in Treating Patients With Neuroendocrine Tumor That Is Metastatic or Unlikely to Respond to Surgery or Radiation Therapy

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 neuroendocrine tumor that is metastatic or unlikely to respond to surgery or radiation therapy.

OBJECTIVES: * Provide treatment with antineoplastons A10 and AS2-1 for patients with metastatic or incurable neuroendocrine tumors. * 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 2 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.

Merkel Cell Carcinoma
Islet Cell Carcinoma
Neuroendocrine Carcinoma
Pituitary Tumor

DRUG: antineoplaston A10
DRUG: antineoplaston AS2-1
PROCEDURE: alternative product therapy
PROCEDURE: biological therapy
PROCEDURE: biologically based therapies
PROCEDURE: cancer prevention intervention
PROCEDURE: complementary and alternative therapy
PROCEDURE: differentiation therapy

BC-NE-2
CDR0000066557 (REGISTRY Identifier) (REGISTRY: PDQ (Physician Data Query))

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 1999-11-01	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2013-07-09
First Submitted that Met QC Criteria 2003-01-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2013-07-10
First Posted (ESTIMATED) 2003-01-27	Results First Posted N/A	Last Verified 2006-12

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Histologically confirmed incurable neuroendocrine tumor that is unlikely to respond to existing therapy, meeting 1 of the following criteria:
Metastatic disease
Disease that is not curable with surgery or radiotherapy
Measurable disease by MRI or CT scan
Tumor must be at least 2 cm

18 and over

Karnofsky 60-100%

At least 2 months

WBC at least 2,000/mm^3
Platelet count at least 50,000/mm^3

No hepatic insufficiency
Bilirubin no greater than 2.5 mg/dL
SGOT and SGPT no greater than 5 times upper limit of normal

No renal insufficiency
Creatinine no greater than 2.5 mg/dL
No history of renal conditions that contraindicate high dosages of sodium

No uncontrolled hypertension
No history of congestive heart failure
No history of other cardiovascular conditions that contraindicate high dosages of sodium

No serious lung disease, such as chronic obstructive pulmonary disease

Not pregnant or nursing
Fertile patients must use effective contraception during and for 4 weeks after study participation
No active infection
No concurrent nonmalignant systemic disease
Not a high medical or psychiatric risk

At least 4 weeks since prior immunotherapy
No concurrent immunomodulating agents

At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)

Concurrent corticosteroids allowed

At least 8 weeks since prior radiotherapy

Recovered from prior surgery

Prior cytodifferentiating agents allowed
No prior antineoplastons
No other concurrent antineoplastic agents

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_CHAIR: Stanislaw R. Burzynski, MD, PhD, Burzynski Research Institute

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record