Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Treatment	Closed	Over 18	NCI	CWRU-ICC-7Y02 NCT00068523

Objectives

Primary

1. 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%.
2. Determine the frequency of treatment-related toxicity leading to death and frequency of disease relapse resulting in death in patients treated with this regimen.
3. Determine the incidence and severity of acute and chronic graft-versus-host disease in patients treated with this regimen.

Secondary

1. Determine the rates of donor allogeneic hematologic engraftment in patients treated with this regimen.
2. 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.
3. Determine the event-free and overall survival of patients treated with this regimen.

Entry 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/mm³
    • 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]

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

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%
• FEV₁ 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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Ireland Cancer Center at University Hospitals/Case Medical Center

Omer Koc, MD, Principal investigator(Contact information may not be current)		Ph: 216-844-8797

Registry Information
Official Title		Immunomodulation by Ultraviolet B-Irradiation (UVB) to Facilitate Allogeneic Stem Cell Transplantation for Treatment of Hematologic Malignancies
Trial Start Date		2003-06-06
Registered in ClinicalTrials.gov		NCT00068523
Date Submitted to PDQ		2003-07-28
Information Last Verified		2004-07-26
NCI Grant/Contract Number		P30-CA43703

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