Overview
Ultraviolet-B Light Therapy and Allogeneic Stem Cell Transplantation in Treating Patients With Hematologic Malignancies
Status:
Completed
Completed
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
All
All
Summary
RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy. Sometimes the transplanted cells from a donor are rejected by the body's normal cells. Ultraviolet-B light therapy given before and after allogeneic stem cell transplantation may help prevent this from happening. PURPOSE: Clinical trial to study the effectiveness of combining ultraviolet-B light therapy with allogeneic stem cell transplantation in treating patients who have hematologic malignancies.Phase:
N/AAccepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Case Comprehensive Cancer CenterCollaborator:
National Cancer Institute (NCI)Treatments:
Antilymphocyte Serum
Cyclophosphamide
Cyclosporine
Cyclosporins
Fludarabine
Fludarabine phosphate
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Criteria
DISEASE CHARACTERISTICS:- Histologically confirmed diagnosis of any of the following hematologic malignancies:
- Acute myeloid leukemia (AML) meeting any of the following criteria:
- First complete remission with high-risk karyotype
- Translocations t(15;17) allowed only if failed first-line induction
therapy OR molecular evidence of persistent disease exists
- Translocations t(8;21) and inv(16) allowed only if failed first-line
induction therapy
- Second or subsequent complete remission
- Minimal residual disease*
- Acute lymphoblastic leukemia meeting any of the following criteria:
- Failed induction therapy and has minimal residual disease* by salvage
therapy
- First complete remission with high-risk karyotype (e.g., t[4;11] or t[9;22])
- Relapsed disease allowed provided a second or subsequent complete remission
or minimal residual disease* is achieved
- Chronic myelogenous leukemia meeting any of the following criteria:
- Persistent or relapsed disease after 1 year of imatinib mesylate therapy
- Accelerated phase or blast crisis
- Blast crisis allowed after reinduction chemotherapy places disease in
chronic phase
- Myelodysplastic syndromes meeting any of the following criteria:
- Refractory to medical management
- Cytogenetic abnormalities predictive of transformation into acute leukemia,
including 5q-, 7q-, monosomy 7 and trisomy 8, or evidence of evolution to
AML (e.g., refractory anemia with excess blasts (RAEB) or RAEB in
transformation)
- Non-Hodgkin's lymphoma or Hodgkin's lymphoma meeting any of the following
criteria:
- Beyond first complete remission or failed primary induction therapy and
demonstrated sensitivity to therapy during the 6 months before
transplantation
- Recurrent disease after autologous stem cell transplantation
- Must be at least 3 months posttransplantation
- Cyclin D1+ mantle cell lymphoma allowed after induction therapy and in first
remission
- Multiple myeloma meeting either of the following criteria:
- Refractory or relapsed disease
- Residual disease after autologous transplantation
- Chronic lymphocytic leukemia (CLL) meeting all of the following criteria:
- Peripheral blood absolute lymphocyte count greater than 5,000/mm^3
- Small to moderate size lymphocytes and less than 55% pro-lymphocytes,
atypical lymphocytes, or lymphoblasts morphologically
- B-cell or T-cell
- Myeloproliferative disorders, including myelofibrosis
- Philadelphia negative
- Availability of a HLA-A, B, and DR identical family donor OR HLA-A, B, and DR
genetically matched unrelated donor
- Must meet 1 of the following criteria:
- At least 55 years of age at time of transplantation
- Received extensive prior therapy (i.e., more than 1 year of alkylator therapy or
more than 2 different prior salvage regimens) or stem cell transplantation with
myeloablative conditioning (either autologous or allogeneic)
- Presenting with comorbid condition (e.g., abnormal cardiac, pulmonary, or renal
function and/or prior life-threatening infection) that precludes eligibility for
enrollment in allogeneic transplantation protocols with full ablation
conditioning
- No active CNS disease NOTE: *Defined as having no circulating blasts, absolute
neutrophil count greater than 1,000/mm3 and less than 10% blasts in bone marrow at
least 3 weeks after last systemic chemotherapy
PATIENT CHARACTERISTICS:
Age
- See Disease Characteristics
- Over 18
Performance status
- ECOG 0-2
Life expectancy
- At least 3 months
Hematopoietic
- See Disease Characteristics
Hepatic
- Bilirubin no greater than 2.0 mg/dL
- ALT/AST no greater than 4 times normal
Renal
- See Disease Characteristics
- Creatinine less than 2.0 mg/dL OR
- Creatinine clearance at least 50 mL/min
Cardiovascular
- See Disease Characteristics
- Normal cardiac function by echocardiogram or radionuclide scan
- Shortening fraction or ejection fraction at least 40% of normal
Pulmonary
- See Disease Characteristics
- DLCO at least 60%
- FEV_1 greater than 50% of predicted
- Pulse oximetry greater than 85%
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- No uncontrolled active infection
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
- At least 2 weeks since prior biologic response modifiers, signal transduction
inhibitors, or monoclonal antibodies
Chemotherapy
- See Disease Characteristics
- At least 4 weeks since prior systemic conventional chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- Recovered from prior therapy
- No concurrent sun block/sunscreen or any cosmetic that may act as a sunscreen (e.g.,
lotion with SPF) on the days of scheduled ultraviolet-B light therapy