Antineoplaston Therapy in Treating Patients With High-Grade Stage II - Stage IV Non-Hodgkin's Lymphoma

Non-hodgkins Lymphoma Clinical Trial

Official title:

Phase II Study of Antineoplaston A10 and AS2-1 in Patients With Non-Hodgkin's Lymphoma, High Grade

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00003501
• Other study ID #: CDR0000066541
• Secondary ID: BC-LY-08
• Status: Terminated
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: February 1, 2018
• Start date: April 10, 1996
• Est. completion date: July 2, 2003

Study information

• Verified date: February 2018
• Source: Burzynski Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Current therapies for Refractory or Recurrent High-Grade Stage II - IV Non-Hodgkin's Lymphoma provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Refractory or Recurrent High-Grade Stage II - IV Non-Hodgkin's Lymphoma.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Refractory or Recurrent High-Grade Stage II - IV Non-Hodgkin's Lymphoma.

Description:

Refractory or Recurrent High-Grade Stage II - IV Non-Hodgkin's Lymphoma patients 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 Refractory or Recurrent High-Grade Stage II - IV Non-Hodgkin's Lymphoma, 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 Refractory or Recurrent High-Grade Stage II - IV Non-Hodgkin's Lymphoma.

• To determine objective response, tumor size is measured utilizing physical examination, radiologic studies, and bone marrow biopsies as necessary, 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: July 2, 2003
• Est. primary completion date: July 2, 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

DISEASE CHARACTERISTICS:

• Histologically proven stage II, III, or IV high-grade non-Hodgkin's lymphoma that has not responded to, or has relapsed after a standard primary chemotherapy regimen plus at least 1 standard second-line salvage chemotherapy regimen NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adoptedby PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• At least 2 months

Hematopoietic:

• WBC greater than 2000/mm^3

• Platelet count greater than 50,000/mm^3

Hepatic:

• Bilirubin no greater than 2.5 mg/dL

Renal:

• 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 cardiovascular conditions that contraindicate high dosages of sodium

Other:

• Not pregnant or nursing

• Fertile patients must use effective contraception during and for 4 weeks after study participation

• No active infection requiring treatment

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 4 weeks since prior immunotherapy and recovered

• No concurrent immunomodulatory agent (e.g., interferon or interleukin-2)

Chemotherapy:

• See Disease Characteristics

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

• No concurrent antineoplastic agent

Endocrine therapy:

• At least 4 weeks since prior dexamethasone, prednisone, or other corticosteroids

• No concurrent corticosteroid

Radiotherapy:

• At least 8 weeks since prior radiotherapy and recovered

Surgery:

• Not specified

Other:

• No prior antineoplaston therapy

• No concurrent antibiotics, antifungals, or antivirals

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-hodgkins Lymphoma

Intervention

Drug:
• Antineoplaston therapy (Atengenal + Astugenal)
Patients with Refractory or Recurrent High-Grade Stage II - IV Non-Hodgkin's Lymphoma 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.

Locations

Country	Name	City	State
United States	Burzynski Clinic	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Burzynski Research Institute

Country where clinical trial is conducted

United States,