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Immunomodulation by Ultraviolet B-Irradiation (UVB) to Facilitate Allogeneic Stem Cell Transplantation for Treatment of Hematologic Malignancies


N/A
18 Years
N/A
Not Enrolling
Both
Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases

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Trial Information

Immunomodulation by Ultraviolet B-Irradiation (UVB) to Facilitate Allogeneic Stem Cell Transplantation for Treatment of Hematologic Malignancies


OBJECTIVES:

Primary

- Determine the safety of ultraviolet-B light therapy and allogeneic peripheral blood
stem cell transplantation in patients with hematologic malignancies by demonstrating
100-day mortality no greater than 15% and 1-year mortality no greater than 40%.

- Determine the frequency of treatment-related toxicity leading to death and frequency of
disease relapse resulting in death in patients treated with this regimen.

- Determine the incidence and severity of acute and chronic graft-versus-host disease in
patients treated with this regimen.

Secondary

- Determine the rates of donor allogeneic hematologic engraftment in patients treated
with this regimen.

- Determine the rate and quality of immune reconstitution in the peripheral blood and the
composition of immune cells in the skin before and after transplantation in these
patients.

- Determine the event-free and overall survival of patients treated with this regimen.

OUTLINE:

- Preparative regimen: Patients receive fludarabine IV over 30 minutes on days -8 to -4
and cyclophosphamide IV over 1 hour on days -3 to -2. Patients also receive
anti-thymocyte globulin IV over 4 hours on days -2 to -1. Patients undergo
ultraviolet-B (UVB) light therapy every other day between days -10 and -2 for a total
of 3 days.

- Allogeneic peripheral blood stem cell (PBSC) transplantation: Patients undergo PBSC
transplantation on day 0.

- Graft-versus-host disease prophylaxis: Patients receive oral cyclosporine on days -1 to
100 and methylprednisolone (oral or IV) on days 5-15.

- Posttransplantation UVB light therapy: Following PBSC transplantation, patients undergo
UVB light therapy twice weekly on week 1 (at least 1 day apart) and three times weekly
on weeks 2-4.

Donor lymphocyte infusion is performed per institutional guidelines for patients in whom
emerging donor chimerism post allogeneic PBSC transplantation is not progressing
(consistently below 50% during first 3 months), for whom donor chimerism is receding (to
below 25%) despite cessation of cyclosporine, or who relapse within 24 months after
allografting.

Patients are followed at least monthly for 3 months and then at 6, 12, 18, and 24 months.

PROJECTED ACCRUAL: A total of 23-36 patients will be accrued for this study.

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Study the effectiveness of combining ultraviolet-B light therapy with allogeneic stem cell transplantation in treating patients who have hematologic malignancies.

Outcome Time Frame:

Patients are followed at least monthly for 3 months and then at 6, 12, 18, and 24 months.

Safety Issue:

No

Principal Investigator

Omer N. Koc, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

ICC7Y02

NCT ID:

NCT00068523

Start Date:

June 2003

Completion Date:

Related Keywords:

  • Chronic Myeloproliferative Disorders
  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Diseases
  • refractory multiple myeloma
  • accelerated phase chronic myelogenous leukemia
  • adult acute lymphoblastic leukemia in remission
  • adult acute myeloid leukemia in remission
  • blastic phase chronic myelogenous leukemia
  • recurrent adult acute lymphoblastic leukemia
  • recurrent adult acute myeloid leukemia
  • refractory chronic lymphocytic leukemia
  • relapsing chronic myelogenous leukemia
  • de novo myelodysplastic syndromes
  • previously treated myelodysplastic syndromes
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult Burkitt lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent mantle cell lymphoma
  • refractory anemia with excess blasts in transformation
  • refractory anemia with excess blasts
  • secondary myelodysplastic syndromes
  • Philadelphia chromosome negative chronic myelogenous leukemia
  • chronic idiopathic myelofibrosis
  • B-cell chronic lymphocytic leukemia
  • T-cell large granular lymphocyte leukemia
  • chronic phase chronic myelogenous leukemia
  • recurrent adult Hodgkin lymphoma
  • recurrent adult T-cell leukemia/lymphoma
  • stage III chronic lymphocytic leukemia
  • stage IV chronic lymphocytic leukemia
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • recurrent mycosis fungoides/Sezary syndrome
  • secondary acute myeloid leukemia
  • atypical chronic myeloid leukemia
  • myelodysplastic/myeloproliferative disease, unclassifiable
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult acute myeloid leukemia with t(15;17)(q22;q12)
  • Neoplasms
  • Leukemia
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Hematologic Neoplasms
  • Myelodysplastic-Myeloproliferative Diseases

Name

Location

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065