Non Hodgkin Lymphoma Clinical Trial

High-Dose Chemotherapy With or Without Total-Body Irradiation Followed by Autologous Stem Cell Transplant in Treating Patients With Hematologic Cancer or Solid Tumors

Summary

This pilot trial studies different high-dose chemotherapy regimens with or without total-body irradiation (TBI) to compare how well they work when given before autologous stem cell transplant (ASCT) in treating patients with hematologic cancer or solid tumors. Giving high-dose chemotherapy with or without TBI before ASCT stops the growth of cancer cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood or bone marrow and stored. More chemotherapy may be given to prepare for the stem cell transplant. The stem cells are then returned to the patient to replace the blood forming cells that were destroyed by the chemotherapy.

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Full Description

PRIMARY OBJECTIVES:

I. Estimate the progression free survival (PFS) distribution for Hodgkin lymphoma (HL), non-Hodgkin lymphoma (NHL) and multiple myeloma (MM) for each disease-specific high dose therapy regimen.

SECONDARY OBJECTIVES:

I. Estimate the PFS distribution for amyloidosis, acute leukemia and selected solid tumors for each disease-specific high dose therapy regimen.

II. Explore the role of risk factors in the outcome of all treated patients. III. Examine the high dose therapy regimen-related toxicity (RRT) and overall survival after bone marrow transplant (BMT).

OUTLINE:

Patients are assigned to conditioning regimens based on disease, age, and co-morbidities.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed diagnosis of malignant hematologic disorders, amyloidosis or solid tumor malignancy
Recurrent or refractory disease or disease at high risk for recurrence
Hodgkin Disease (HL): Relapsed or refractory disease after chemotherapy with a minimum of one standard regimen
Non-Hodgkin Lymphoma (NHL): (Low, Intermediate or High Grade) Relapsed or refractory disease after chemotherapy with at least one standard regimen or first complete remission (CR) lymphoblastic or small, non-cleaved cell lymphoma at high risk of relapse by high International Prognostic Index (IPI) Score
Acute Myeloid Leukemia (AML): Low or High Risk disease in first or second CR or greater in patients in whom the risks of an allogeneic transplant outweigh the benefits
Acute Lymphoblastic Leukemia (ALL): Low or high risk disease in first or second CR in whom the risks of an allogeneic transplant outweigh the benefits
Multiple Myeloma (MM): Low or high risk in first or greater response (stable disease or better) or for responding patients at first progression
Other Malignant Lymphoproliferative Disorders: (chronic lymphocytic lymphoma [CLL], Waldenstroms macroglobulinemia, relapsed or refractory disease after first-line chemotherapy
Amyloidosis: primary or previously treated
Solid Tumors: Testicular cancer patients who have relapsed disease or primary progressive disease which is responding to salvage therapy; relapsed or advanced-stage newly diagnosed neuroblastoma (NBL) or small round blue cell tumors (SRBCT) in patients 30 years of age; other patients with solid tumors who have recurred following conventional treatment or are at high risk for relapse, and demonstrate chemosensitivity
Patients with malignancies who would be treated with an autologous stem cell transplant but have a syngeneic donor; a syngeneic donor would be considered to have the same risk as an autologous stem cell transplant patient
Performance status 0-2 (Karnofsky performance status [KPS] >= 70%); patients with amyloidosis or MM with decreased KPS due to disease are eligible
Life expectancy > 2 months
Pulmonary function tests; diffusing capacity of the lung for carbon monoxide (DLCO) or diffusing volume of the alveolar volume (DLVA) >= 50% predicted; DLCO to be corrected for hemoglobin and/or alveolar ventilation
Cardiac ventricular ejection fraction >= 50% by radionuclide ventriculogram or echocardiogram
Bilirubin < 3 x normal
Alkaline phosphatase, serum glutamic oxaloacetic transaminase (SGOT) < 3 x normal
Calculated creatinine clearance < 40 cc/min by the modified Cockcroft-Gault formula for adults or the Schwartz formula for pediatrics
Glomerular filtration rate by renal scan for neuroblastoma patients, to determine dosing parameters
Positive cytomegalovirus (CMV) immunoglobulin M (IgM) and/or positive hepatitis serologies demonstrating infection will require an Infectious Disease consult and subsequent clearance
Any active infection will require an Infectious Disease consult and subsequent clearance
Peripheral Blood Counts of polymorphonuclear neutrophil (PMN) > 1500/uL
Platelet (Plt) > 75,000/uL

Prior to stem cell storage:

No radiation within three weeks before stem cell harvest
Bone marrow may be used in conjunction with blood progenitor cells
Hematologic Malignancy patients with human immunodeficiency virus (HIV) positivity but on appropriate anti-retroviral therapy may go autotransplant with the following laboratory tests; (CD4+ cell count > 75 cells per microliter and HIV copy number < 100,000 per microliter and with Infectious Disease clearance
Acute Leukemia, HL, NHL, MM and Solid Tumor patients must have received 2 cycles of chemotherapy followed by disease-specific restaging prior to mobilization and collection of stem cells; small round blue cell tumor patients must have received either standard therapy or surgical intervention; the disease status and response to therapy must be known prior to transplant to establish the disease status at transplant; amyloidosis patients may proceed to BMT without receiving chemotherapy

No serious organ dysfunction unless it is caused by the underlying disease, exclusion criteria include the following:

Uncontrolled or severe cardiovascular disease, including recent (< 6 months) myocardial infarction, congestive heart failure, symptomatic angina, life-threatening arrhythmia or hypertension
Active bacterial, viral, or fungal infection
Active peptic ulcer disease
Uncontrolled diabetes mellitus
No serious medical or psychiatric illness
Not pregnant
No psychiatric conditions which would prevent delivery of care; psychology clearance is necessary

Allogeneic BMT not possible, or not desirable

Age > 65 years
No compatible donor identified
Estimated risk of graft vs. host disease complications greater than risk of recurrence after autologous BMT

Adequate bone marrow or blood stem cell dose obtained:

For blood stem cells: total CD 34+ >= 2 x 10^6/kg or if unable to collect this dose, a total nucleated cell bone marrow dose of >= l x 10^8/kg

Study is for people with:

Non Hodgkin Lymphoma

Estimated Enrollment:

174

Study ID:

NCT00536601

Recruitment Status:

Completed

Sponsor:

Roswell Park Cancer Institute

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There is 1 Location for this study

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Roswell Park Cancer Institute
Buffalo New York, 14263, United States

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Study is for people with:

Non Hodgkin Lymphoma

Estimated Enrollment:

174

Study ID:

NCT00536601

Recruitment Status:

Completed

Sponsor:


Roswell Park Cancer Institute

How clear is this clinincal trial information?

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