Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Macroglobulinemia of Waldenstrom
Antineoplaston therapy (Atengenal + Astugenal)
Troubles des Protéines Sanguines+13
+ Maladies Cardiovasculaires
+ Maladies Hématologiques
Étude thérapeutique
Résumé
Date de début de l'étude : 18 février 1999
Date à laquelle le premier participant a commencé l'étude.Recurrent or Refractory Waldenstrom's Macroglobulinemia patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity. OBJECTIVES: To determine the efficacy of Antineoplaston therapy in patients with Recurrent or Refractory Waldenstrom's Macroglobulinemia, 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 Recurrent or Refractory Waldenstrom's Macroglobulinemia. 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.
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.De 18 à 99 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.Conditions
Pathologie
Critères
DISEASE CHARACTERISTICS: Histologically confirmed recurrent or progressive Waldenstrom's macroglobulinemia that is unlikely to respond to existing therapy, including surgery, radiotherapy, and chemotherapy Evidence of tumor by MRI, CT scan, chest x-ray, or radionuclide scan Must have received and failed at least one standard first-line therapy (e.g., corticosteroid/alkylator combination) Biochemical evidence of Waldenstrom's macroglobulinemia Abnormal proteins in serum and urine PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: At least 2 months Hematopoietic: WBC at least 2000/mm3 Platelet count at least 50,000/mm3 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 No active infection No non-malignant systemic disease Not a high medical or psychiatric risk PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy No concurrent immunomodulating agent Chemotherapy: See Disease Characteristics At least 4 weeks (6 weeks since nitrosoureas) since prior chemotherapy No concurrent antineoplastic agents Endocrine therapy: See Disease Characteristics Concurrent corticosteroids allowed Radiotherapy: See Disease Characteristics At least 8 weeks since prior radiotherapy Surgery: See Disease Characteristics Recovered from prior surgery Other: No prior antineoplastons Prior cytodifferentiating agents allowed
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Un seul groupe d'intervention est désigné dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalCentres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site