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

Primary Purpose

Merkel Cell Carcinoma, Islet Cell Carcinoma, Neuroendocrine Carcinoma

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
antineoplaston A10
antineoplaston AS2-1
alternative product therapy
biological therapy
biologically based therapies
cancer prevention intervention
complementary and alternative therapy
differentiation therapy
Sponsored by
Burzynski Research Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Merkel Cell Carcinoma focused on measuring ACTH-producing pituitary tumor, prolactin-producing pituitary tumor, growth hormone-producing pituitary tumor, recurrent pituitary tumor, TSH producing pituitary tumor, nonfunctioning pituitary tumor, somatostatinoma, stage III Merkel cell carcinoma, recurrent Merkel cell carcinoma, neuroendocrine carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: 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 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 and SGPT no greater than 5 times upper limit of normal Renal: No renal insufficiency Creatinine no greater than 2.5 mg/dL No history of renal conditions that contraindicate high dosages of sodium Cardiovascular: No uncontrolled hypertension No history of congestive heart failure No history of other cardiovascular conditions that contraindicate high dosages of sodium Pulmonary: No serious lung disease, such as 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 concurrent nonmalignant systemic disease Not a high medical or psychiatric risk PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy No concurrent immunomodulating agents Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) Endocrine therapy: Concurrent corticosteroids allowed Radiotherapy: At least 8 weeks since prior radiotherapy Surgery: Recovered from prior surgery Other: Prior cytodifferentiating agents allowed No prior antineoplastons No other concurrent antineoplastic agents

Sites / Locations

  • Burzynski Clinic

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
July 9, 2013
Sponsor
Burzynski Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00003514
Brief Title
Antineoplaston Therapy in Treating Patients With Neuroendocrine Tumor That Is Metastatic or Unlikely to Respond to Surgery or Radiation Therapy
Official Title
Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Metastatic or Incurable Neuroendocrine Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
December 2006
Overall Recruitment Status
Withdrawn
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Burzynski Research Institute

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Merkel Cell Carcinoma, Islet Cell Carcinoma, Neuroendocrine Carcinoma, Pituitary Tumor
Keywords
ACTH-producing pituitary tumor, prolactin-producing pituitary tumor, growth hormone-producing pituitary tumor, recurrent pituitary tumor, TSH producing pituitary tumor, nonfunctioning pituitary tumor, somatostatinoma, stage III Merkel cell carcinoma, recurrent Merkel cell carcinoma, neuroendocrine carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
antineoplaston A10
Intervention Type
Drug
Intervention Name(s)
antineoplaston AS2-1
Intervention Type
Procedure
Intervention Name(s)
alternative product therapy
Intervention Type
Procedure
Intervention Name(s)
biological therapy
Intervention Type
Procedure
Intervention Name(s)
biologically based therapies
Intervention Type
Procedure
Intervention Name(s)
cancer prevention intervention
Intervention Type
Procedure
Intervention Name(s)
complementary and alternative therapy
Intervention Type
Procedure
Intervention Name(s)
differentiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: 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 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 and SGPT no greater than 5 times upper limit of normal Renal: No renal insufficiency Creatinine no greater than 2.5 mg/dL No history of renal conditions that contraindicate high dosages of sodium Cardiovascular: No uncontrolled hypertension No history of congestive heart failure No history of other cardiovascular conditions that contraindicate high dosages of sodium Pulmonary: No serious lung disease, such as 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 concurrent nonmalignant systemic disease Not a high medical or psychiatric risk PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy No concurrent immunomodulating agents Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) Endocrine therapy: Concurrent corticosteroids allowed Radiotherapy: At least 8 weeks since prior radiotherapy Surgery: Recovered from prior surgery Other: Prior cytodifferentiating agents allowed No prior antineoplastons No other concurrent antineoplastic agents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stanislaw R. Burzynski, MD, PhD
Organizational Affiliation
Burzynski Research Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Burzynski Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77055-6330
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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