Busulfan, Melphalan, and Thiotepa in Treating Patients Who Are Undergoing an Autologous Stem Cell Transplant for Hodgkin's or Non-Hodgkin's Lymphoma

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Chemotherapy, such as busulfan, melphalan, and thiotepa, may destroy cancerous blood-forming cells (stem cells) in the blood and bone marrow. Giving the patient their healthy stem cells will help their bone marrow make new stem cells that become red blood cells, white blood cells, and platelets.

PURPOSE: This phase II trial is studying how well busulfan, melphalan, and thiotepa work in treating patients who are undergoing an autologous stem cell transplant for Hodgkin's or non-Hodgkin's lymphoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OHSU Knight Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Busulfan; Lenograstim; Melphalan; Thiotepa

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of 1 of the following:

• Intermediate- or high-grade non-Hodgkin's lymphoma (NHL), meeting 1 of the following criteria:

• In first complete remission (CR) AND at high-risk for relapse, as defined by all of the following criteria:

• High age-adjusted International Prognostic Index category AND meets the following criteria at diagnosis:

• Stage III or IV disease

• Lactic dehydrogenase abnormal

• Eastern Cooperative Oncology Group (ECOG) score 0-2

• Mantle cell histology

• Primary refractory disease

• Beyond first CR

• Low-grade NHL

• Beyond second relapse

• Hodgkin's lymphoma

• Primary refractory disease OR beyond first CR

• Must have an adequate number of stored autologous peripheral blood stem cells (PBSCs) (i.e., 2.0 x 10^6 hematopoietic progenitor cell antigen (CD34)-positive cells/kg)

• Patients who are not able to mobilize a sufficient number of PBSCs may use bone marrow instead

• No active CNS disease 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

• 0 to 70

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Bilirubin < 2 times upper limit of normal (ULN)

• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 times ULN

Renal

• Creatinine ≤ 2.0 mg/dL

• Creatinine clearance ≥ 50 mL/min

Pulmonary

• No significant pulmonary dysfunction, defined as Diffusing Capacity the Lung for Carbon monoxide (DLCO) < 60% of predicted

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception for ≥ 2 months before and during study participation

• HIV negative

• No significant active infection that would preclude PBSC transplantation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior transplantation

• No other concurrent blood products during PBSC transplantation

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• More than 60 days since prior local or regional radiotherapy

Surgery

• Not specified

Other

• More than 30 days since prior investigational drugs

• No concurrent amphotericin