|Phase I||Treatment||Completed||18 to 50||DFCI-90039|
I. Evaluate whether anti-B4-blocked ricin (anti-B4-bR) immunotoxin-treated autologous bone marrow can reconstitute hematologic and immunologic function after marrow ablative therapy. II. Compare hematologic engraftment of anti-B4-bR-treated bone marrow with previous results using bone marrow treated with anti-J5 (anti-CD10) and anti-J2 (anti-CD9) and complement. III. Compare hematologic engraftment of anti-B4-bR-treated autologous bone marrow with results using normal allogeneic T12-depleted bone marrow. IV. Evaluate overall and disease-free survival in patients receiving an anti-B4-bR-treated autologous bone marrow transplantation.
Histologically confirmed acute lymphocytic leukemia (ALL) in second or subsequent complete remission Less than 5% blasts in bone marrow No blasts in peripheral blood Significant reactivity of leukemic cells with anti-B4-bR at time of relapse required No HLA-compatible donor available for standard allogeneic transplant
No greater than 3,000 cGy prior radiotherapy to the brain
Age: 18 to 50 Performance status: Not specified Hematopoietic: WBC greater than 3,000 Platelets greater than 100,000 Hepatic: Bilirubin no greater than 1.5 mg/dl Renal: Creatinine no greater than 1.6 mg/dl Creatinine clearance at least 50 ml/min Cardiovascular: No uncompensated CHF Other: No significant intercurrent infection No HIV positivity No pregnant women
Up to 12 patients will be accrued; if marrow engraftment is substantially delayed in 3 of the first 6, 4 of the first 9, or 5 of the first 12 patients, accrual will cease.
The following acronyms are used: Anti-B4-bR anti-B4-blocked-ricin immunotoxin, NSC-639185 BMT Bone Marrow Transplant CTX Cyclophosphamide, NSC-26271 TBI Total-Body Irradiation Single-Agent High-Dose Chemotherapy plus Radiotherapy followed by Hematopoietic Rescue. HD CTX; plus TBI (equipment not specified); followed by autologous BMT.
Trial Lead Organizations
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
|Michael Robertson, MD, Protocol chair|
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.