RATIONALE: Photopheresis allows patient white blood cells to be treated with ultraviolet light and drugs outside the body to inactivate T cells. Pentostatin may suppress the immune system and reduce the chance of developing graft-versus-host disease following bone marrow transplantation. Combining photopheresis with pentostatin and total-body irradiation may be effective in killing cancer cells before bone marrow transplantation.

PURPOSE: Phase II trial to study the effectiveness of photophoresis, pentostatin, and total-body irradiation as a reduced-intensity regimen before allogeneic bone marrow transplantation in treating patients who have relapsed non-Hodgkin's or Hodgkin's lymphoma.

Condition	Treatment or Intervention	Phase
adult Hodgkin's lymphoma adult T-cell leukemia and lymphoma adult non-Hodgkin's lymphoma anaplastic large cell lymphoma mycosis fungoides and Sezary syndrome	Drug: cyclosporine  Drug: methotrexate  Drug: methoxsalen  Drug: mycophenolate mofetil  Drug: pentostatin  Procedure: UV light therapy  Procedure: allogeneic bone marrow transplantation  Procedure: biological response modifier therapy  Procedure: bone marrow ablation with stem cell support  Procedure: bone marrow transplantation  Procedure: chemotherapy  Procedure: graft versus host disease prophylaxis/therapy  Procedure: peripheral blood stem cell transplantation  Procedure: phototherapy  Procedure: supportive care/therapy	Phase II

Further Study Details: 

OBJECTIVES:

• Determine the rate of stable engraftment of donor cells in patients with relapsed non-Hodgkin's or Hodgkin's lymphoma treated with a nonmyeloablative conditioning regimen followed by allogeneic bone marrow transplantation.
• Determine the extent and duration of acute and chronic graft-versus-host disease in patients treated with this regimen.
• Determine the 100-day survival and long-term disease-free survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

• Nonmyeloablative conditioning regimen: Patients undergo extracorporeal photopheresis using methoxsalen and UV light on 2 consecutive days between days -7 to -4. Patients receive pentostatin IV continuously on days -3 to -2 and undergo total body irradiation on day -1.
• Allogeneic bone marrow transplantation: Patients undergo infusion of allogeneic bone marrow or stem cells on day 0.
• Graft-versus-host disease prophylaxis: Patients receive oral or IV cyclosporine beginning on day -1 and continuing until 6 months after transplantation, oral mycofenolate mofetil beginning on day 100 and continuing for 1 year, and methotrexate IV on days 1 and 3. Patients are followed at day 100, every 3 months for 1 year, every 6 months for 2 years, and then annually for 2 years.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 1.8 years.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of non-Hodgkin's or Hodgkin's lymphoma considered to be incurable with any other therapeutic interventions
• Low-grade lymphoma patients must have exhausted all treatment options expected to result in long-term survival or palliation
• Relapsed disease after prior high-dose chemotherapy and autologous stem cell transplantation OR
• Failed to mobilize adequate stem cells in order to undergo an autologous stem cell transplantation
• Measurable or evaluable disease
• Availability of 1 of the following bone marrow donors:
• 5/6 or 6/6 HLA-matched related donor (sibling, parent, or child)
• 6/6 matched unrelated donor by molecular typing at HLA A, B, C, D, DR
• No umbilical cord blood donors NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• AST and ALT less than 3 times upper limit of normal (ULN)
• Bilirubin less than 3 times ULN

Renal

• Creatinine clearance greater than 50 mL/min

Cardiovascular

• LVEF at least 45% by MUGA or echocardiogram

Pulmonary

• DLCO at least 50% of predicted
• FEV_1 at least 50% of predicted

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Physically and psychologically capable of undergoing bone marrow transplantation and its attendant period of strict isolation
• HIV negative
• Able to receive total body irradiation of 400 cGy
• No evidence of active infection

PRIOR CONCURRENT THERAPY: Biologic therapy

• See Disease Characteristics
• At least 90 days since prior autologous stem cell transplantation

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• More than 2 weeks since prior parenteral antibiotics

Study chairs or principal investigators

Francine Marie Foss, MD,  Study Chair,  Cancer Center at Tufts - New England Medical Center   
Kenneth B. Miller, MD,  Beth Israel Deaconess Medical Center   

Study ID Numbers:  CDR0000285659; ECOG-1402; NCT00057954
Record last reviewed:  March 2003
Last Updated:  January 6, 2005
Record first received:  April 7, 2003
ClinicalTrials.gov Identifier:  NCT00057954
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08