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Antineoplaston Therapy in Treating Patients With Recurrent or Refractory High-Grade Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2004 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003501
First received: November 1, 1999
Last updated: July 23, 2008
Last verified: April 2004
  Purpose

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 studies the effectiveness of antineoplaston therapy in treating patients who have recurrent or refractory high-grade stage II, stage III, or stage IV non-Hodgkin's lymphoma after receiving chemotherapy.


Condition Intervention Phase
Lymphoma
Drug: antineoplaston A10
Drug: antineoplaston AS2-1
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Antineoplaston A10 and AS2-1 in Patients With Non-Hodgkin's Lymphoma, High Grade

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 40
Study Start Date: August 1998
Detailed Description:

OBJECTIVES:

  • Determine the safety and effectiveness of antineoplastons A10 and AS2-1 in patients with serious or immediately life-threatening recurrent or refractory high-grade non-Hodgkin's lymphoma.
  • Describe response to, tolerance to, and side effects of this regimen in these patients.

OUTLINE: This is an open-label study.

Patients receive gradually escalating doses of antineoplaston A10 and antineoplaston AS2-1 by intravenous injection 6 times daily until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of disease progression or unacceptable toxicity. After 12 months, patients with responding or stable disease may continue treatment.

Tumors are measured at least every 8 weeks for 6 months, every 3 months for 1.5 years, every 6 months for 2 years, and then annually for 2 years.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003501

Locations
United States, Texas
Burzynski Clinic
Houston, Texas, United States, 77055-6330
Sponsors and Collaborators
Burzynski Research Institute
Investigators
Study Chair: Stanislaw R. Burzynski, MD, PhD Burzynski Research Institute
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003501     History of Changes
Other Study ID Numbers: CDR0000066541, BC-LY-8
Study First Received: November 1, 1999
Last Updated: July 23, 2008
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III adult immunoblastic large cell lymphoma
stage III adult lymphoblastic lymphoma
stage III adult Burkitt lymphoma
stage IV adult immunoblastic large cell lymphoma
stage IV adult lymphoblastic lymphoma
stage IV adult Burkitt lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent adult Burkitt lymphoma
contiguous stage II adult immunoblastic large cell lymphoma
contiguous stage II adult Burkitt lymphoma
contiguous stage II adult lymphoblastic lymphoma
noncontiguous stage II adult immunoblastic large cell lymphoma
noncontiguous stage II adult Burkitt lymphoma
noncontiguous stage II adult lymphoblastic lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 25, 2014