High-Dose Chemotherapy, Total-Body Irradiation, and Autologous Stem Cell Transplantation or Bone Marrow Transplantation in Treating Patients With Hematologic Cancer or Solid Tumors

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with autologous stem cell transplantation or autologous bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: This phase II trial is studying how well eight different high-dose chemotherapy regimens with or without total-body irradiation followed by autologous stem cell transplantation or autologous bone marrow transplantation works in treating patients with hematologic malignancies or solid tumors.

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

Details

• Lead Sponsor: Roswell Park Cancer Institute
• Treatments: Busulfan; Carboplatin; Carmustine; Cyclophosphamide; Etoposide; Melphalan; Thiotepa

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed hematologic or solid tumor malignancy, including any of the following:

• Acute myeloid leukemia

• First remission and not eligible for allogeneic transplantation; recurrent disease after combination chemotherapy with at least 1 standard regimen; or second remission

• Not eligible for protocol CLB-9620 or CLB-9621

• Acute lymphoblastic leukemia

• First complete remission without appropriate allogeneic donor

• Chronic myelogenous leukemia

• Chronic, accelerated, or blast phase

• Lymphoproliferative diseases*

• Chronic lymphocytic leukemia

• Multiple myeloma

• Waldenstrom's macroglobulinemia

• Low-grade non-Hodgkin's lymphoma (NHL) NOTE: *Recurrent or persistent, symptomatic disease after first-line chemotherapy, or subsequently

• Amyloidosis

• Primary or previously treated disease

• NHL (intermediate- and high-grade)

• Resistant or recurrent disease after combination chemotherapy with at least 1 standard regimen

• First remission lymphoblastic or small, non-cleaved cell lymphoma at high risk of relapse

• CNS disease OR bone marrow disease and lactic dehydrogenase greater than 300 IU/L

• Hodgkin's lymphoma

• Resistant or recurrent disease after combination chemotherapy with at least 1 standard regimen

• Solid tumors

• High-risk and metastatic breast cancer

• Testicular cancer that has relapsed OR primary progressive disease that is responding to salvage therapy

• Other solid tumors that have recurred after conventional therapy OR are at high risk for relapse, and demonstrate chemosensitivity

• Less than 10% marrow tumor present histologically (maximum of 15% involvement allowed if purged)

• Allogeneic marrow transplantation not possible or not desirable for any of the following reasons:

• Over 60 years of age

• No compatible donor identified

• Estimated risk of graft-versus-host disease complications greater than risk of recurrence after autologous bone marrow transplantation

• Patients with disease progression in a site of prior radiotherapy (4,000 cGy or more) are not eligible for total body irradiation (TBI) regimens

• Hormone receptor status:

• Not specified 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

• 4 and over (patients 60 years of age and over are not eligible for TBI)

Sex

• Male or female

Menopausal status

• Not specified

Performance status

• Karnofsky 70-100%

Life expectancy

• More than 2 months

Hematopoietic

• WBC greater than 3,000/mm^3*

• Polymorphonuclear leukocyte count greater than 1,500/mm^3*

• Platelet count greater than 75,000/mm^3*

• Marrow cellularity greater than 20%*

• No marrow fibrosis* NOTE: *Before marrow storage

Hepatic

• Bilirubin less than 3 times normal

• Alkaline phosphatase less than 3 times normal

• AST less than 3 times normal

• Hepatitis status known

Renal

• Creatinine clearance at least 50 mL/min (not required for patients with amyloidosis or multiple myeloma)

Cardiovascular

• Ventricular ejection fraction at least 50% by radionuclide ventriculogram or echocardiogram

• No myocardial infarction within the past 6 months

• No congestive heart failure

• No symptomatic angina

• No life-threatening arrhythmia or hypertension

Pulmonary

• DLCO or DLVA at least 50% of predicted (DLCO must be corrected for hemoglobin and/or alveolar ventilation)

Other

• Not pregnant

• HIV negative

• Cytomegalovirus status known

• No active bacterial, viral, or fungal infection

• No active peptic ulcer disease

• No uncontrolled diabetes mellitus

• No serious organ dysfunction unless it is caused by the underlying disease

• No other serious medical or psychiatric illness that would preclude giving informed consent or complying with study requirements

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics

Chemotherapy

• See Disease Characteristics

• No prior cumulative nitrosourea dose greater than 600 mg/m^2

• No prior cumulative bleomycin dose greater than 150 units/m^2

• No prior cumulative doxorubicin dose greater than 450 mg/m^2

• No prior cumulative daunorubicin dose greater than 600 mg/m^2

• Patients with prior high-dose cyclophosphamide (greater than 150 mg/kg per cycle) and high-dose etoposide (greater than 2,400 mg/m^2 per cycle) are not eligible for the etoposide/cyclophosphamide/TBI conditioning regimen

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics

• More than 3 weeks since prior radiotherapy (before blood stem cell harvest)

• Prior cumulative doses of radiotherapy must not exceed the following:

• Spine/spinal cord: 4,000 cGy

• Mediastinum: 4,000 cGy

• Heart: 4,000 cGy

• Kidney (whole): 1,500 cGy

• Small bowel: 4,000 cGy

• Brain: 4,000 cGy

• Liver (whole): 2,000 cGy

• Lungs (whole): 1,500 cGy

• Bone: 5,000 cGy

Surgery

• Not specified