Bone Marrow Transplantation With Specially Treated Bone Marrow in Treating Patients With Hematologic Cancer That Have Not Responded to Previous Therapy

• Status: Completed
• Trial end date: 2002-03-08
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells. Sometimes the transplanted cells can make an immune response against the body's normal tissues. Treatment of the donor bone marrow with the patient's white blood cells and a monoclonal antibody may prevent this from happening.

PURPOSE: Phase I trial to study the effectiveness of bone marrow transplantation with specially treated bone marrow in treating patients who have hematologic cancer that has not responded to previous therapy.

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

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cyclophosphamide; Cyclosporine; Cyclosporins; Leucovorin; Levoleucovorin; Methotrexate; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• Age ≤40 years.

• Diagnoses-patients with the following hematologic malignancies and bone marrow failure syndromes:

• Acute myelogenous leukemia-induction failure, relapse, second or greater complete remission (CR)

• Acute lymphocytic leukemia-induction failure, relapse, second or greater CR, first CR with t(9;22), t(8;14), or t(4;11)

• Non-Hodgkin's lymphoma (intermediate or high grade) which has failed to achieve CR with at least two induction regimens, relapse, second or greater CR

• Multiple myeloma with poor prognostic features (elevated 0-2 microglobulin or high labeling index)

• Hodgkin's disease in relapse or which fails to achieve CR after two chemotherapy regimens

• Congenital or acquired bone marrow failure - poorly responsive to or intolerant of current therapy

• Myelodysplastic syndrome of all subtypes except refractory anemia (RA)

• Patient has a haploidentical family member that meets medical criteria for donation.

• Eligibility for other transplant types:

• Patient considered likely to have clinical deterioration and rapid disease progression during an unrelated donor search, or

• Patient who has already had an unproductive donor search or

• Patient ineligible for or has refused autologous transplant

• Adequate renal and hepatic function for age:

• Serum creatinine <2 x ULN

• Alanine aminotransferase (ALT, SGPT) x ULN

• Aspartate aminotransferase (AST, SGOT) x ULN

• Total bilirubin 5_2 x ULN except if bilirubin is elevated due to Gilbert's syndrome or hemolytic anemia

• Adequate cardiac and pulmonary function for age.

• ECOG Performance Status 0, 1, or 2 or Lansky performance scale >50% for patients <16 years of age.

• Voluntary witnessed written informed consent. Children will be asked for assent where appropriate.

• The patient, if female, must be post-menopausal, premenarcheal, or sterile, or if the patient is of childbearing potential, she must be practicing a method of birth control considered effective and medically acceptable by the investigator for a minimum of 1 month prior to study entry and at least 2 months after the study end.

• Patient must have undergone successful leukapheresis to obtain adequate antigen presenting cells.

• Any patient who enters the study in a relapse state, with evidence of end organ (pulmonary, renal, or hepatic) toxicity, or with recent recovery from infection, who may potentially have little benefit from this protocol, must have his/her eligibility status discussed with the Principal Investigator.

• Patient must have life expectancy of at least 12 weeks.

Exclusion Criteria

• Eligibility for other transplant types:

• Patient has family donor who is matched or single antigen mismatched at HLA-A, HLA-B, HLA-DR, and HLA-DQ. Donorrecipient matching must be evaluated via both phenotype and genotype.

• Patient has available unrelated donor who is matched at HLA-A, HLA-B, and HLA-DR. Donor-recipient matching must be evaluated via both phenotype and genotype.

• Active uncontrolled infection (continued positive blood or soft tissue cultures despite appropriate antibiotic treatment)

• Positive 13-HCG in a female of childbearing potential

• Evidence of HIV infection or known HIV positive serology

• Any prior bone marrow transplant

• A peripheral blood differential count at the time of leukapheresis with greater than 25% blasts. This exclusion criterion is valid only for the first four patients enrolled.

• Patients with Fanconi's anemia