Overview

Ultraviolet-B Light Therapy and Allogeneic Stem Cell Transplantation in Treating Patients With Hematologic Malignancies

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
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/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Case Comprehensive Cancer Center
Collaborator:
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