HIGH-DOSE CYCLOPHOSPHAMIDE, ETOPOSIDE, AND CISPLATIN (CEP) WITH RESCUE BY AUTOLOGOUS BONE MARROW OR AUTOLOGOUS PERIPHERAL BLOOD STEM CELLS IN PATIENTS WITH RELAPSED OR REFRACTORY HODGKIN'S DISEASE
cisplatin
+ cyclophosphamide
+ etoposide
Maladies hématologiques et lymphatiques+6
+ Maladies du Système Immunitaire
+ Troubles immunoprolifératifs
Étude thérapeutique
Résumé
Date de début de l'étude : 1 février 1993
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Determine the curative potential of high-dose cyclophosphamide, etoposide, and cisplatin (CEP) followed by syngeneic or autologous bone marrow and/or autologous peripheral blood stem cell (PBSC) rescue in patients with relapsed or refractory stage I-IV Hodgkin's lymphoma. Determine the overall response rate and survival of patients treated with this regimen. Determine the toxicity of this regimen in these patients. Determine the differences in the rate of engraftment, response, and survival of patients treated with bone marrow vs PBSC transplantation. Determine the response rate and survival of patients treated with late consolidative radiotherapy after recovery from transplantation. Determine the toxicity of late consolidative radiotherapy after recovery from transplantation in these patients. OUTLINE: Syngeneic or autologous bone marrow and/or autologous peripheral blood stem cells (PBSC) are harvested. Syngeneic bone marrow transplantation is preferred for patients with a qualifying identical twin donor. Patients without a syngeneic donor who have a history of lymphomatous involvement of the bone marrow or are profoundly hypocellular undergo harvest of PBSC alone. Patients without a syngeneic donor who have no history of lymphomatous involvement of the bone marrow undergo harvest of autologous bone marrow or PBSC. Patients receive conditioning comprising cyclophosphamide IV over 1 hour on days -6 to -3 and etoposide IV over 1 hour every 12 hours and cisplatin IV continuously on days -6 to -4. Bone marrow and/or PBSC are infused on day 0. (Patients requiring more than 25 bags of stem cells receive bone marrow transplantation on day 0 and PBSC transplantation on day 1.) After recovery from transplantation, eligible patients receive consolidative radiotherapy to any site of prior bulk disease (greater than 5 cm) present at any time before transplantation and any site of disease present at the time of transplantation. Patients are followed at 3, 6, and 12 months and then annually thereafter. PROJECTED ACCRUAL: A maximum of 30 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.De 15 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 proven stage I-IV Hodgkin's lymphoma Must have refractory or relapsed disease, defined by 1 of the following: Failure to achieve a complete remission (CR) after 4 courses of conventional-dose front-line chemotherapy Disease in second or greater remission Patients should be encouraged to undergo transplantation prior to a third salvage regimen Patients previously treated with multiple regimens considered on a case-by-case basis No chemoresistant disease, defined as active progression with tumor growth greater than 25% by volume during first-line chemotherapy Patients who respond to second-line chemotherapy may be eligible Stable residual masses after conventional-dose chemotherapy not considered treatment failures Active (refractory or relapsed) disease must be proven histologically or documented by gallium nitrate uptake Syngeneic marrow transplantation offered to patients with consenting identical twin donor No CNS involvement by lymphoma PATIENT CHARACTERISTICS: Age: 15 to 60 (selected patients up to age 70 may be eligible) Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC greater than 4,000/mm^3 Absolute neutrophil count greater than 2,000/mm^3 Platelet count greater than 100,000/mm^3 Hepatic: Bilirubin less than 2.0 mg/dL SGOT and SGPT less than 2 times upper limit of normal Albumin greater than 3.0 g/dL Renal: Must meet 1 of the following criteria: Creatinine less than 1.8 mg/dL Creatinine clearance greater than 60 mL/min BUN less than 20 mg/dL Cardiovascular: Left ventricular ejection fraction at least 50% Pulmonary: DLCO, FEV_1, and FVC greater than 50% of predicted OR Resting pO_2 greater than 70 mm Hg on room air Other: HIV negative No severe neurologic or emotional disorders No active infection No other disease that would limit life expectancy Not pregnant Fertile patients must use effective contraception Adequate psychosocial support required PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics Endocrine therapy Not specified Radiotherapy Not specified 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
Fox Chase - Temple Cancer Center
Philadelphia, United StatesOuvrir Fox Chase - Temple Cancer Center dans Google Maps