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Fludeoxyglucose F 18 Positron Emission Tomography in Predicting Risk of Relapse in Patients With Non-Hodgkin's Lymphoma Who Are Undergoing Combination Chemotherapy With or Without Autologous Stem Cell or Bone Marrow Transplant

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
filgrastim
rituximab
busulfan
cisplatin
cyclophosphamide
cytarabine
doxorubicin hydrochloride
etoposide
methylprednisolone
prednisone
vincristine sulfate
autologous bone marrow transplantation
peripheral blood stem cell transplantation
positron emission tomography
fludeoxyglucose F 18
radiation therapy
Sponsored by
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lymphoma focused on measuring contiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, stage I adult diffuse large cell lymphoma, stage III adult diffuse large cell lymphoma, stage IV adult diffuse large cell lymphoma, contiguous stage II grade 3 follicular lymphoma, noncontiguous stage II grade 3 follicular lymphoma, stage I grade 3 follicular lymphoma, stage III grade 3 follicular lymphoma, stage IV grade 3 follicular lymphoma, anaplastic large cell lymphoma, stage I adult T-cell leukemia/lymphoma, stage II adult T-cell leukemia/lymphoma, stage III adult T-cell leukemia/lymphoma, stage IV adult T-cell leukemia/lymphoma

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed aggressive non-Hodgkin's lymphoma of 1 of the following subtypes: Diffuse large B-cell lymphoma Mediastinal (thymic) B-cell lymphoma Grade 3 follicular lymphoma Anaplastic large cell lymphoma Peripheral T-cell lymphoma Must have adequate staging of disease by the following techniques: CT scan or MRI of affected sites Bone marrow biopsy (in cases where results influence the duration of chemotherapy only) Lumbar puncture (if clinically indicated) Stage I-IV disease Any International Prognostic Index risk category Radiographically measurable disease None of the following aggressive non-Hodgkin's subtypes are allowed: Mantle cell lymphoma Lymphoblastic lymphoma Burkitt's lymphoma Mycosis fungoides/Sezary's syndrome HTLV-1-associated T-cell leukemia/lymphoma Primary CNS lymphoma HIV-associated lymphoma Transformed lymphomas No prior diagnosis of another hematologic malignancy No known progressive disease during prior first-line chemotherapy No active CNS involvement by lymphoma, except CNS involvement at diagnosis that is previously treated and in remission PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-4 (0-2 for peripheral blood stem cell [PBSC] or bone marrow transplantation [BMT] patients) Life expectancy Not specified Hematopoietic Absolute neutrophil count > 1,000/mm^3* Platelet count ≥ 75,000/mm^3 NOTE: *PBSC or BMT patients only Hepatic Bilirubin ≤ 2.0 mg/dL unless due to Gilbert's disease or lymphoma* No known significant hepatic dysfunction that is not expected to improve and would preclude PBSC or BMT NOTE: *PBSC or BMT patients only Renal Creatinine ≤ 2.0 mg/dL* No known significant renal dysfunction that is not expected to improve and would preclude PBSC or BMT NOTE: *PBSC or BMT patients only Cardiovascular Ejection fraction ≥ 45% by echocardiogram or MUGA* No known significant cardiac dysfunction that is not expected to improve and would preclude PBSC or BMT NOTE: *PBSC or BMT patients only; a cardiology consult and evaluation may override ejection fraction criterion Pulmonary FEV_1 and FVC ≥ 50% of predicted for patients who have not received thoracic or mantle radiotherapy (75% of predicted for patients who have received thoracic or mantle radiotherapy)* No known significant pulmonary dysfunction that is not expected to improve and would preclude PBSC or BMT NOTE: *PBSC or BMT patients only Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy within the past 3 years except carcinoma in situ of the cervix or nonmelanoma skin cancer No known HIV positivity OR HIV negative (for PBSC or BMT patients only) No serious illness that would preclude study participation No contraindication to autologous BMT PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics No more than 3 prior courses of chemotherapy for lymphoma Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified

Sites / Locations

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Outcomes

Primary Outcome Measures

2-year event free survival

Secondary Outcome Measures

Overall survival
Predictive value of early negative fludeoxyglucose F 18 positron emission tomography (FDG-PET)
Correlation of International Prognostic Index risk category with FDG-PET results and overall outcome

Full Information

First Posted
October 12, 2005
Last Updated
November 1, 2017
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00238368
Brief Title
Fludeoxyglucose F 18 Positron Emission Tomography in Predicting Risk of Relapse in Patients With Non-Hodgkin's Lymphoma Who Are Undergoing Combination Chemotherapy With or Without Autologous Stem Cell or Bone Marrow Transplant
Official Title
Autologous Blood or Marrow Transplantation for Aggressive Non-Hodgkin's Lymphoma Based on Early [18F] FDG-PET Scanning
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
February 2004 (Actual)
Primary Completion Date
September 17, 2007 (Actual)
Study Completion Date
September 17, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Giving chemotherapy with an autologous stem cell or bone marrow transplant may allow more chemotherapy to be given so that more cancer cells are killed. Procedures, such as fludeoxyglucose F 18 positron emission tomography (FDG-PET) (done during chemotherapy) may help doctors predict a patient's risk of relapse and help plan the best treatment. PURPOSE: This phase II trial is studying how well FDG-PET works in predicting risk of relapse in patients with aggressive non-Hodgkin's lymphoma who are undergoing combination chemotherapy with or without autologous stem cell or bone marrow transplant.
Detailed Description
OBJECTIVES: Primary Determine event-free survival of patients with aggressive non-Hodgkin's lymphoma treated with early high-dose therapy and autologous peripheral blood stem cell (PBSC) or bone marrow transplantation (BMT) based on positive fludeoxyglucose F 18 positron emission tomography (FDG-PET) results obtained during first-line chemotherapy. Compare event-free survival of patients treated with this regimen with historical event-free survival of patients with positive FDG-PET results obtained during first-line chemotherapy that are not treated with early high-dose therapy. Secondary Compare overall survival of patients treated with a standard treatment regimen vs early high-dose therapy and autologous PBSC or BMT based on FDG-PET results obtained during first-line chemotherapy. Determine the predictive value of an early negative FDG-PET result in these patients. Correlate International Prognostic Index risk category with FDG-PET results and overall outcome in these patients. OUTLINE: This is a pilot study. First-line chemotherapy: Patients receive cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1, oral prednisone on days 1-5, and rituximab IV on day 1 (patients with CD20-positive disease only) OR another standard first-line chemotherapy regimen. Treatment repeats every 14-21 days for 2 or 3 courses in the absence of disease progression or unacceptable toxicity. Radiographic staging: Between days 11-20 of course 2 or 3 OR days 11-13 of course 3 of first-line chemotherapy, patients receive fludeoxyglucose F 18 (FDG) IV. One hour later, patients undergo whole-body FDG-positron emission tomography (PET) and CT scan. Patients with no evidence of malignant disease by FDG-PET (i.e., negative result) receive a standard treatment regimen that may include localized radiotherapy for limited stage or bulky disease followed, 4-6 weeks later, by a repeat whole-body FDG-PET and CT scan. Patients with progressive disease after first-line chemotherapy are removed from the study. Patients with evidence of malignant disease by FDG-PET (i.e., positive result) and stable disease or better proceed to ESHAP chemotherapy. ESHAP chemotherapy: Patients receive etoposide IV over 2 hours, methylprednisolone IV, and cisplatin IV over 3 hours on days 1-4 followed by cytarabine IV over 2 hours on day 5. Patients with CD20-positive disease also receive rituximab IV on day 1. Treatment repeats every 14-21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Beginning 1 day after completion of course 2, patients receive filgrastim (G-CSF) subcutaneously once daily followed by leukapheresis to collect peripheral blood stem cells (PBSC). Some patients may also undergo bone marrow (BM) harvest if sufficient PBSC are not collected. Patients with a sufficient number of stem cells proceed to high-dose therapy and autologous PBSC transplantation (PBSCT) or BM transplantation (BMT). High-dose therapy and PBSCT or BMT: No more than 4 weeks after completion of PBSC collection or BM harvest, patients receive high-dose therapy that may include cyclophosphamide and total-body irradiation OR busulfan and cyclophosphamide. Patients then undergo PBSCT or BMT. Between 4-6 weeks after completion of PBSCT or BMT, patients undergo repeat whole-body FDG-PET and CT scan. Patients may also undergo consolidative radiotherapy to the sites of bulky disease at the discretion of the physician. After completion of study treatment, patients are followed at 4 weeks, every 3 months for 2 years, every 6 months for 1 year, and then annually for 2 years. PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 18 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
contiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, stage I adult diffuse large cell lymphoma, stage III adult diffuse large cell lymphoma, stage IV adult diffuse large cell lymphoma, contiguous stage II grade 3 follicular lymphoma, noncontiguous stage II grade 3 follicular lymphoma, stage I grade 3 follicular lymphoma, stage III grade 3 follicular lymphoma, stage IV grade 3 follicular lymphoma, anaplastic large cell lymphoma, stage I adult T-cell leukemia/lymphoma, stage II adult T-cell leukemia/lymphoma, stage III adult T-cell leukemia/lymphoma, stage IV adult T-cell leukemia/lymphoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
filgrastim
Intervention Type
Biological
Intervention Name(s)
rituximab
Intervention Type
Drug
Intervention Name(s)
busulfan
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
cytarabine
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Type
Drug
Intervention Name(s)
methylprednisolone
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Type
Drug
Intervention Name(s)
vincristine sulfate
Intervention Type
Procedure
Intervention Name(s)
autologous bone marrow transplantation
Intervention Type
Procedure
Intervention Name(s)
peripheral blood stem cell transplantation
Intervention Type
Procedure
Intervention Name(s)
positron emission tomography
Intervention Type
Radiation
Intervention Name(s)
fludeoxyglucose F 18
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
2-year event free survival
Secondary Outcome Measure Information:
Title
Overall survival
Title
Predictive value of early negative fludeoxyglucose F 18 positron emission tomography (FDG-PET)
Title
Correlation of International Prognostic Index risk category with FDG-PET results and overall outcome

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed aggressive non-Hodgkin's lymphoma of 1 of the following subtypes: Diffuse large B-cell lymphoma Mediastinal (thymic) B-cell lymphoma Grade 3 follicular lymphoma Anaplastic large cell lymphoma Peripheral T-cell lymphoma Must have adequate staging of disease by the following techniques: CT scan or MRI of affected sites Bone marrow biopsy (in cases where results influence the duration of chemotherapy only) Lumbar puncture (if clinically indicated) Stage I-IV disease Any International Prognostic Index risk category Radiographically measurable disease None of the following aggressive non-Hodgkin's subtypes are allowed: Mantle cell lymphoma Lymphoblastic lymphoma Burkitt's lymphoma Mycosis fungoides/Sezary's syndrome HTLV-1-associated T-cell leukemia/lymphoma Primary CNS lymphoma HIV-associated lymphoma Transformed lymphomas No prior diagnosis of another hematologic malignancy No known progressive disease during prior first-line chemotherapy No active CNS involvement by lymphoma, except CNS involvement at diagnosis that is previously treated and in remission PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-4 (0-2 for peripheral blood stem cell [PBSC] or bone marrow transplantation [BMT] patients) Life expectancy Not specified Hematopoietic Absolute neutrophil count > 1,000/mm^3* Platelet count ≥ 75,000/mm^3 NOTE: *PBSC or BMT patients only Hepatic Bilirubin ≤ 2.0 mg/dL unless due to Gilbert's disease or lymphoma* No known significant hepatic dysfunction that is not expected to improve and would preclude PBSC or BMT NOTE: *PBSC or BMT patients only Renal Creatinine ≤ 2.0 mg/dL* No known significant renal dysfunction that is not expected to improve and would preclude PBSC or BMT NOTE: *PBSC or BMT patients only Cardiovascular Ejection fraction ≥ 45% by echocardiogram or MUGA* No known significant cardiac dysfunction that is not expected to improve and would preclude PBSC or BMT NOTE: *PBSC or BMT patients only; a cardiology consult and evaluation may override ejection fraction criterion Pulmonary FEV_1 and FVC ≥ 50% of predicted for patients who have not received thoracic or mantle radiotherapy (75% of predicted for patients who have received thoracic or mantle radiotherapy)* No known significant pulmonary dysfunction that is not expected to improve and would preclude PBSC or BMT NOTE: *PBSC or BMT patients only Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy within the past 3 years except carcinoma in situ of the cervix or nonmelanoma skin cancer No known HIV positivity OR HIV negative (for PBSC or BMT patients only) No serious illness that would preclude study participation No contraindication to autologous BMT PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics No more than 3 prior courses of chemotherapy for lymphoma Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lode J. Swinnen, MD
Organizational Affiliation
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Official's Role
Study Chair
Facility Information:
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-2410
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Fludeoxyglucose F 18 Positron Emission Tomography in Predicting Risk of Relapse in Patients With Non-Hodgkin's Lymphoma Who Are Undergoing Combination Chemotherapy With or Without Autologous Stem Cell or Bone Marrow Transplant

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