Radiolabeled Monoclonal Antibody, Combination Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory B-Cell Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Radiolabeled monoclonal antibodies can locate cancer cells and either kill them or deliver cancer killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody plus combination chemotherapy and peripheral stem cell transplantation in treating patients who have recurrent or B-cell cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Garden State Cancer Center at the Center for Molecular Medicine and Immunology
• Treatments: Antibodies; Cytarabine; Epratuzumab; Etoposide; Ifosfamide

Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed recurrent or refractory B-cell malignancy that has failed at least one standard therapy Stage II to IV non-Hodgkin's lymphoma B-cell chronic lymphocytic leukemia, hairy cell leukemia, or Waldenstrom's macroglobulinemia allowed if: Autologous bone marrow or peripheral blood stem cells (PBSC) with no greater than 5% tumor involvement available Estimated radiation dose to marrow no greater than 3,000 cGy (bone marrow involvement of greater than 25% is allowed provided stem cell contamination and predicted marrow radiation doses are below the above cited cut off values) At least 1 confirmed site of tumor targeted by pretherapy indium In 111 humanized LL2 Autologous peripheral blood stem cells (PBSC) or bone marrow available No active brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Karnofsky 70-100% Life expectancy: At least 3 months Hematopoietic: WBC at least 3,000/mm3 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 2 mg/dL Renal: Creatinine less than 1.5 times upper limit of normal Cardiovascular: Cardiac ejection fraction greater than 50% Pulmonary: DLCO greater than 60% predicted Forced vital capacity greater than 60% predicted Other: No severe anorexia, nausea, or vomiting HIV negative No prisoners No concurrent significant medical complication that would preclude study compliance Not pregnant Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study

PRIOR CONCURRENT THERAPY: Biologic therapy: Prior low dose radioimmunotherapy allowed Chemotherapy: No prior high dose chemotherapy with PBSC rescue At least 4 weeks since prior chemotherapy and recovered Endocrine therapy: At least 2 weeks since prior corticosteroids and recovered Radiotherapy: Prior low dose radioimmunotherapy allowed Prior radiotherapy to less than 35% of red marrow allowed At least 4 weeks since prior radiotherapy to index lesion Surgery: At least 4 weeks since major surgery