Overview

S9805, High-Dose Melphalan Plus Peripheral Stem Cell Transplantation Followed by Interferon Alfa in Treating Patients With Waldenstrom's Macroglobulinemia

Status:
Completed
Trial end date:
2004-01-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy and kill more tumor cells. Interferon alfa may interfere with the growth of the cancer cells. PURPOSE: Phase II trial to study the effectiveness of high-dose melphalan plus peripheral stem cell transplantation followed by interferon alfa in treating patients with Waldenstrom's macroglobulinemia.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Southwest Oncology Group
Collaborator:
National Cancer Institute (NCI)
Treatments:
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Interferon-alpha
Interferons
Melphalan
Criteria
DISEASE CHARACTERISTICS: Immunologically diagnosed Waldenstrom's macroglobulinemia (WM)
Evaluable quantifiable IgM One of the following criteria must be met: 1) Patient
demonstrates clinical symptoms such as fatigue, dizziness, visual inacuity, or hemorrhagic
manifestations of WM with anemia, hyperviscosity, thrombocytopenia, or coagulopathies 2)
Advanced tumor mass present involving ONE of the following: Extensive lymphadenopathy
(greater than 2 cm) Hepato or splenomegaly palpable on clinical examination Marked bone
marrow infiltration greater than 50% 3) Progressive disease; i.e., increase in IgM
concentration by at least 50%, and/or a drop of greater than 2 g/dL in hemoglobin (in the
absence of gastrointestinal bleeding), and/or a greater than 50,000/mm3 decrease in
platelets

PATIENT CHARACTERISTICS: Age: Under 70 Performance status: SWOG 0-2 Life expectancy: Not
specified Hematopoietic: See Disease Characteristics Hepatic: Not specified Renal: Not
specified Cardiovascular: At least 6 months since myocardial infarction No congestive heart
failure No arrhythmia refractory to therapy Ejection fraction within normal range by MUGA
or ECHO Pulmonary: FEV1 at least 50% of predicted DLCO at least 50% of predicted Other: Not
pregnant or nursing Effective contraception required of fertile patients No significant
comorbid condition No uncontrolled life-threatening infection No uncontrolled diabetes No
other malignancy within past 5 years except adequately treated basal or squamous cell skin
cancer, carcinoma in situ of the cervix or adequately treated stage I or II cancer
currently in remission HIV negative Hepatitis B surface antigen negative

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks
since chemotherapy and recovered Endocrine therapy: Not specified Radiotherapy: At least 4
weeks since radiotherapy and recovered Surgery: Not specified