Reduced-Intensity Regimen Before Allogeneic Bone Marrow Transplantation in Treating Patients With Relapsed Non-Hodgkin's or Hodgkin's Lymphoma - Full Text View

Sponsors and Collaborators:	Eastern Cooperative Oncology Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00057954

Purpose

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: This phase II trial is studying how well giving photophoresis together with pentostatin and total-body irradiation as a reduced-intensity regimen before allogeneic bone marrow transplantation works in treating patients with relapsed non-Hodgkin's or Hodgkin's lymphoma.

Condition	Intervention	Phase
Lymphoma	Drug: cyclosporine Drug: methotrexate Drug: methoxsalen Drug: mycophenolate mofetil Drug: pentostatin Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation	Phase II

MedlinePlus related topics: Bone Marrow Transplantation Cancer Hodgkin's Disease Lymphoma

Drug Information available for: Methotrexate Methoxsalen Cyclosporin Cyclosporine Mycophenolate Mofetil Mycophenolate mofetil hydrochloride Pentostatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase II Study of Reduced Intensity Allogeneic Bone Marrow Transplantation for the Treatment of Relapsed Non-Hodgkin and Hodgkin Lymphoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Engraftment [ Designated as safety issue: No ]

Estimated Enrollment:	36
Study Start Date:	June 2005
Estimated Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Determine the rate of stable engraftment of donor cells in patients with relapsed non-Hodgkin's or Hodgkin's lymphoma treated with a reduced toxicity conditioning regimen followed by allogeneic (sibling or unrelated) 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 overall survival and long-term progression-free survival of patients treated with this regimen.
Evaluate the feasibility of collection of molecular chimerism studies at baseline, days 30, 100, 6 months and one and two years and at relapse.

OUTLINE: This is a multicenter study.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of non-Hodgkin's or Hodgkin's lymphoma
- Relapsed disease following a course of high-dose chemotherapy or autologous stem cell transplantation
Availability of 1 of the following bone marrow donors:
- 5/6 or 6/6 HLA-matched related donor (sibling, parent, or child)
- 10/10 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00057954

Locations

United States, Colorado
Aurora Presbyterian Hospital
Aurora, Colorado, United States, 80012
Boulder Community Hospital
Boulder, Colorado, United States, 80301-9019
CCOP - Colorado Cancer Research Program
Denver, Colorado, United States, 80224-2522
Hope Cancer Care Center at Longmont United Hospital
Longmont, Colorado, United States, 80502
Rose Medical Center
Denver, Colorado, United States, 80220
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, United States, 80933
Porter Adventist Hospital
Denver, Colorado, United States, 80210
Presbyterian - St. Luke's Medical Center
Denver, Colorado, United States, 80218
North Suburban Medical Center
Thornton, Colorado, United States, 80229
Sky Ridge Medical Center
Lone Tree, Colorado, United States, 80124
St. Joseph Hospital
Denver, Colorado, United States, 80218
St. Mary - Corwin Regional Medical Center
Pueblo, Colorado, United States, 81004
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
Grand Junction, Colorado, United States, 81502
Swedish Medical Center
Englewood, Colorado, United States, 80110
United States, Florida
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
United States, Massachusetts
Tufts-NEMC Cancer Center
Boston, Massachusetts, United States, 02111
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, New Jersey
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065

Sponsors and Collaborators

Eastern Cooperative Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:	Francine M. Foss, MD	Yale University
Investigator:	Kenneth B. Miller, MD	Beth Israel Deaconess Medical Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000285659, ECOG-1402
Study First Received:	April 7, 2003
Last Updated:	November 25, 2008
ClinicalTrials.gov Identifier:	NCT00057954
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent adult Hodgkin lymphoma
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
recurrent mycosis fungoides/Sezary syndrome
recurrent adult T-cell leukemia/lymphoma
anaplastic large cell lymphoma
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

Study placed in the following topic categories:

Pentostatin
Sezary syndrome
Cyclosporine
Hodgkin's disease
Clotrimazole
Miconazole
Hodgkin lymphoma, adult
Cutaneous T-cell lymphoma
Lymphoma, Mantle-Cell
Lymphoma, Follicular
Lymphoma, small cleaved-cell, diffuse
Sezary Syndrome
Lymphoma, B-Cell, Marginal Zone
Mycosis Fungoides
Cyclosporins

Lymphoma, large-cell, immunoblastic
Lymphoma, large-cell
Lymphoma, B-Cell
Burkitt's lymphoma
Leukemia
Mycoses
Methoxsalen
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Large-Cell, Immunoblastic
Mycophenolate mofetil
Lymphoma, Large-Cell, Anaplastic
Methotrexate
Hodgkin Disease
Lymphoma
Chronic lymphocytic leukemia

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Reproductive Control Agents
Folic Acid Antagonists

Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Pharmacologic Actions
Photosensitizing Agents
Neoplasms
Radiation-Sensitizing Agents
Antifungal Agents
Therapeutic Uses
Abortifacient Agents
Antirheumatic Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009