Positron Emission Tomography Using Fludeoxyglucose F 18 in Predicting Response to Treatment in Patients Who Are Receiving Rituximab and Combination Chemotherapy for Newly Diagnosed Non-Hodgkin's Lymphoma

Lymphoma Clinical Trial

Official title:

Prognostic Significance of Early Positron Emission Tomography (PET) With Fluorine-18 Fluorodeoxyglucose ([18F] FDG) in Intermediate and High Grade Non-Hodgkin's Lymphoma

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00110006
• Other study ID #: CASE2404
• Secondary ID: P30CA043703CASE-
• Status: Withdrawn
• Phase: N/A
• First received: May 3, 2005
• Last updated: June 10, 2010
• Start date: December 2004

Study information

• Verified date: June 2010
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Diagnostic procedures, such as positron emission tomography (PET) using fludeoxyglucose F 18, may help in learning how well chemotherapy works to kill cancer cells and allow doctors to plan better treatment. Comparing results of diagnostic procedures done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.

PURPOSE: This clinical trial is studying positron emission tomography using fludeoxyglucose F 18 to see how well it works in predicting response to treatment in patients who are receiving rituximab and combination chemotherapy for newly diagnosed non-Hodgkin's lymphoma.

Description:

OBJECTIVES:

• Determine the positive and negative predictive values of early positron emission tomography (PET) scanning using fludeoxyglucose F 18 in terms of the probability of patients with newly diagnosed intermediate- or high-grade non-Hodgkin's lymphoma who achieve or do not achieve complete remission, after treatment with 1 course of rituximab and combination chemotherapy comprising cyclophosphamide, doxorubicin, vincristine, and prednisone.

• Determine event free and overall survival of patients with an early positive and negative PET scan treated with this regimen.

• Determine the predictive value of early PET scan response ratio as a continuous variable in terms of response to therapy (assessed at the end of therapy), disease-free survival, and overall survival, in patients treated with this regimen.

• Correlate International Prognostic Index score at presentation with early PET scan results and overall outcome in patients treated with this regimen.

• Correlate the degree of neutropenia 7 to 10 days after the first course of treatment with rituximab and combination chemotherapy with PET scan response and pre-treatment blood CD34-positive cell concentration in these patients.

OUTLINE: This is a multicenter study.

Patients receive fludeoxyglucose F 18 (^18FDG) IV. Beginning 1 hour later, patients undergo whole-body positron emission tomography (PET) scanning. Patients also undergo conventional radiographic staging of their disease.

Patients then receive standard R-CHOP (or an alternative regimen) comprising rituximab IV over 3-6 hours, cyclophosphamide IV over 30 minutes, doxorubicin IV over 5 minutes, and vincristine IV over 5 minutes on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 14-21 days for up to 4 courses in the absence of unacceptable toxicity.

Patients undergo repeat ^18FDG-PET scanning between days 7-10 of course 1, between courses 3 and 4, and then at the completion of R-CHOP. Patients also undergo radiographic restaging of their disease between courses 3 and 4 and at the completion of R-CHOP.

After completion of study treatment, patients are followed every 3-4 months for 2 years, every 6 months for 1 year, and then annually for 3 years.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 2 years.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed newly diagnosed non-Hodgkin's lymphoma (NHL)

• Intermediate- or high-grade disease

• Stage I-IV disease

• Any of the following subtypes are allowed:

• Diffuse large B-cell lymphoma

• Anaplastic large cell lymphoma

• Mantle cell lymphoma

• Grade 3 follicular lymphoma

• Mediastinal B-cell lymphoma

• The following subtypes are not allowed:

• Lymphoblastic lymphoma

• Mycosis fungoides/Sézary's syndrome

• HTLV-1 associated T-cell leukemia or lymphoma

• Primary CNS lymphoma

• HIV-associated lymphoma

• Transformed lymphoma

• Burkitt's lymphoma

• Adequate staging of lymphoma by any of the following methods:

• CT scan or MRI of affected sites

• Unilateral or bilateral bone marrow biopsy

• Positive pre-treatment positron emission tomography (PET) scan

• Lumbar puncture

• Radiographically measurable disease by PET scan

• Any International Prognostic Index risk category allowed

• No prior diagnosis of another hematologic malignancy 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

• 18 and over

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count > 1,000/mm^3*

• Platelet count = 75,000/mm^3* NOTE: *Unless due to NHL

Hepatic

• Bilirubin = 2.0 mg/dL* (excluding Gilbert's disease) NOTE: *Unless due to NHL

Renal

• Creatinine = 2.0 mg/dL (unless due to NHL)

Cardiovascular

• Ejection fraction = 45% by echocardiogram or MUGA

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• HIV negative

• No other malignancy within the past 5 years except superficial nonmelanoma skin cancer or carcinoma in situ of the cervix

• No other serious co-morbid disease that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior rituximab for NHL

• No concurrent filgrastim [G-CSF] during course 1 of study treatment except for patients > 70 years of age OR patients with active infection

Chemotherapy

• No prior chemotherapy for NHL

Endocrine therapy

• No prior steroids for NHL

Radiotherapy

• No prior radiotherapy for NHL

• Concurrent consolidation radiotherapy to sites of bulky disease allowed at the discretion of the attending physician

Surgery

• Not specified

Other

• No other prior treatment for NHL

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin

Intervention

Biological:
• rituximab
Rituximab IV over 3-6 hours. Treatment repeats every 14-21 days for up to 4 courses in the absence of unacceptable toxicity.

Drug:
• cyclophosphamide
Cyclophosphamide IV over 30 minutes. Treatment repeats every 14-21 days for up to 4 courses in the absence of unacceptable toxicity.
• doxorubicin hydrochloride
Doxorubicin IV over 5 minutes. Treatment repeats every 14-21 days for up to 4 courses in the absence of unacceptable toxicity.
• prednisone
Oral prednisone once daily on days 1-5. Treatment repeats every 14-21 days for up to 4 courses in the absence of unacceptable toxicity.
• vincristine sulfate
Vincristine IV over 5 minutes on day 1. Treatment repeats every 14-21 days for up to 4 courses in the absence of unacceptable toxicity.

Procedure:
• positron emission tomography
Beginning 1 hour after receiving fludeoxyglucose F 18, patients undergo whole-body positron emission tomography (PET) scanning. Patients undergo repeat ^18FDG-PET scanning between days 7-10 of course 1, between courses 3 and 4, and then at the completion of R-CHOP.

Radiation:
• fludeoxyglucose F 18
Patients receive fludeoxyglucose F 18 (^18FDG) IV.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete remission as measured by positron emission tomography (PET) at 7-10 days after R-CHOP, and after completion of study treatment		at 7-10 days after R-CHOP, and after completion of study treatment	No
Primary	Overall survival at 7-10 days after R-CHOP, and after completion of study treatment		at 7-10 days after R-CHOP, and after completion of study treatment	No
Primary	Disease-free survival at 7-10 days after R-CHOP, and after completion of study treatment		at 7-10 days after R-CHOP, and after completion of study treatment	No