Clinical Trial: Antineoplaston Therapy in Treating Patients With Stage IV Cancer of the Cervix and/or Vulva

This study is no longer recruiting patients.

Sponsored by: Burzynski Research Institute
Information provided by: National Cancer Institute (NCI)

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 stage IV cancer of the cervix and/or vulva.

Condition Treatment or Intervention Phase
stage IV cervical cancer
recurrent cervical cancer
stage IV vulvar cancer
recurrent vulvar cancer
 Drug: antineoplaston A10
 Drug: antineoplaston AS2-1
 Procedure: biological response modifier therapy
 Procedure: cancer prevention intervention
 Procedure: complementary and alternative therapy
 Procedure: differentiation therapy
Phase II

MedlinePlus related topics:  Cervical Cancer;   Vulvar Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Stage IV Carcinoma of the Uterine Cervix and/or Vulva

Further Study Details: 

OBJECTIVES:

  • Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with incurable carcinoma of the uterine cervix and/or vulva.
  • 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 3 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: A total of 20-40 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven incurable stage IV carcinoma of the uterine cervix and/or vulva that is unlikely to respond to existing therapy
  • 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 known chronic heart failure
  • No uncontrolled hypertension
  • No history of congestive heart failure
  • No history of other cardiovascular conditions that contraindicate high dosages of sodium

Pulmonary:

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • Not a high medical or psychiatric risk
  • No concurrent nonmalignant systemic disease
  • No active infection

PRIOR CONCURRENT THERAPY: Biologic therapy:

  • At least 4 weeks since prior immunotherapy and recovered
  • No concurrent immunomodulatory agents

Chemotherapy:

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

Endocrine therapy:

  • At least 1 month since prior tamoxifen if no progression
  • May enter study immediately if evidence of progression
  • Concurrent corticosteroids allowed

Radiotherapy:

Surgery:

  • Recovered from prior surgery

Other:

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

Location Information


Texas
      Burzynski Clinic, Houston,  Texas,  77055-6330,  United States

Study chairs or principal investigators

Stanislaw R. Burzynski, MD, PhD,  Study Chair,  Burzynski Research Institute   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000066569; BC-UC-2
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003525
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

Resources