Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Primary Central Nervous System Lymphoma
antineoplaston A10
+ antineoplaston AS2-1
+ alternative product therapy
Étude thérapeutique
Résumé
OBJECTIVES: Assess the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with serious or immediately life-threatening primary central nervous system 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 intravenous antineoplaston A10 and antineoplaston AS2-1 6 times per day 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 every 2 months for 6 months, every 3 months for 2 years, every 6 months for years 3 and 4, and then annually for years 5 and 6. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Critères
DISEASE CHARACTERISTICS: Histologically confirmed stage I-IV primary central nervous system lymphoma for which no curative therapy exists Measurable tumor by MRI or CT scan Tumor must be greater than 2 cm in largest diameter PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: At least 2 months Hematopoietic: WBC greater than 2,000/mm^3 Platelet count greater than 50,000/mm^3 Hepatic: Bilirubin no greater than 2.5 mg/dL SGOT and SGPT no greater than 5 times upper limit of normal No hepatic insufficiency Renal: Creatinine no greater than 2.5 mg/dL No history of renal conditions that contraindicate high dosages of sodium Cardiovascular: No cardiac insufficiency No hypertension No history of congestive heart failure No history of other cardiovascular conditions that contraindicate high dosages of sodium Other: Not pregnant or nursing Fertile patients must use effective contraception during and for at least 4 weeks after study participation No serious infection requiring antibiotics, antifungals, or antivirals PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered No concurrent immunomodulatory agents (e.g., interferon or interleukin-2) Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered No concurrent antineoplastic agent Endocrine therapy: Concurrent corticosteroids allowed Must be on stable dose for at least 4 weeks prior to study entry Radiotherapy: At least 8 weeks since prior radiotherapy and recovered Surgery: Not specified Other: No prior antineoplastons
Centres d'étude
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