Autologous Transplantation With and High Dose BCNU and Melphalan Followed by Consolidation With DCEP Plus Taxol/Cisplatin in Patients With Poor Prognosis Low Grade Non-Hodgkin's Lymphoma and Chronic Lymphocyte Leukemia, Who Have Received < or = 12 Months of Standard Therapy
carmustine
+ cisplatin
+ cyclophosphamide
Troubles des Protéines Sanguines+25
+ Maladies Cardiovasculaires
+ Maladie chronique
Étude thérapeutique
Résumé
Date de début de l'étude : 1 janvier 1999
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: I. Evaluate the complete and partial response rates to treatment with peripheral blood stem cell supported high dose carmustine and melphalan followed by consolidation therapy with dexamethasone/cyclophosphamide/etoposide/cisplatin (DCEP) and dexamethasone, paclitaxel, and cisplatin in patients with poor prognosis low grade non-Hodgkin's lymphoma or chronic lymphocytic leukemia and no greater than 12 months of prior standard therapy. II. Evaluate the incidence of early deaths (less than 60 days posttransplant) in comparison with historical experience in this patient population. III. Evaluate the toxicity of posttransplantation chemotherapy with DCEP and dexamethasone, paclitaxel, and cisplatin in these patients. OUTLINE: Patients receive carmustine IV over 2 hours on day -2 and melphalan IV on day -1 followed by peripheral blood stem cell infusion on day 0. At 3 months and 9 months after completion of autologous transplantation, patients receive cyclophosphamide, etoposide, and cisplatin by continuous IV infusion for 4 days plus dexamethasone orally every day for 4 days. At 6 and 12 months after completion of autologous transplantation, patients receive dexamethasone orally every day for 4 days, paclitaxel continuous IV infusion over 6 hours on day 2, and cisplatin continuous IV infusion over 24 hours on day 3. PROJECTED ACCRUAL: There will be 12-35 patients accrued into this study over 1-2.5 years.
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.35 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.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 70 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 low grade follicular lymphoma, mantle cell lymphoma, or chronic lymphocytic leukemia with no greater than 12 months of prior standard therapy Follicular lymphoma Must have poor prognosis disease defined as any of the following: Any nodal or extranodal tumor mass with a diameter more than 7 cm Involvement of at least 3 nodal sites, each of which has a diameter greater than 3 cm Systemic symptoms Substantial splenic involvement no greater than 5 cm below left costal margin Serous effusions (ascites, pleural or pericardial effusions) Orbital or epidural involvement Ureteral compression Leukemia presentation (at least 500/microliter) Increased LDH level Greater than 20% bone marrow involvement Mantle cell lymphoma No mantle zone morphology Chronic lymphocytic leukemia Must have either anemia (hemoglobin less than 10 g/dL), thrombocytopenia (less than 100,000/mm3), cytogenetic abnormalities including +12 and 11q, elevated LDH levels, labeling index at least 2%, systemic symptoms, or hepatosplenomegaly No active CNS disease A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by 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 to 70 Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: At least 4,000/g CD34+ peripheral blood stem cells available See Disease Characteristics Hepatic: Bilirubin no greater than 1.5 mg/dL Transaminases no greater than 4 times upper limit of normal No active chronic hepatitis or liver cirrhosis Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: Left ventricular ejection fraction at least 50% Pulmonary: FEV1, FVC, and DLCO at least 50% of predicted Other: HIV negative No active infection requiring intravenous antibiotics Not pregnant or nursing Effective contraception required of all fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy Endocrine therapy: Prior corticosteroids allowed Radiotherapy: At least 4 weeks since prior local radiotherapy Surgery: Not specified
Centres 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
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, United StatesOuvrir Marlene & Stewart Greenebaum Cancer Center, University of Maryland dans Google Maps