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 - Full Text View

Sponsors and Collaborators:	Case Comprehensive Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00110006

Purpose

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.

Condition	Intervention
Lymphoma	Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: fludeoxyglucose F 18 Drug: prednisone Drug: rituximab Drug: vincristine sulfate Procedure: positron emission tomography

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Cyclophosphamide Prednisone Vincristine sulfate Vincristine Rituximab Fluoride Sodium fluoride Stannous fluoride Fluorodeoxyglucose F18

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Complete remission as measured by positron emission tomography (PET) at 7-10 days after R-CHOP, and after completion of study treatment [ Designated as safety issue: No ]
Overall survival at 7-10 days after R-CHOP, and after completion of study treatment [ Designated as safety issue: No ]
Disease-free survival at 7-10 days after R-CHOP, and after completion of study treatment [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	December 2004
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00110006

Locations

United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065

Sponsors and Collaborators

Case Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Panos Savvides, MD

Case Comprehensive Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000424387, CASE-CWRU-2404, CWRU-100401, CASE-2404
Study First Received:	May 3, 2005
Last Updated:	August 23, 2008
ClinicalTrials.gov Identifier:	NCT00110006
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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
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 mantle cell lymphoma
noncontiguous stage II mantle cell lymphoma
stage I mantle cell lymphoma
stage III mantle cell lymphoma
stage IV mantle cell lymphoma
anaplastic large cell lymphoma

Study placed in the following topic categories:

Prednisone
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Rituximab
Lymphoma, Mantle-Cell
Lymphoma, Follicular
Lymphoma, small cleaved-cell, diffuse
Vincristine
Cyclophosphamide
Mantle cell lymphoma

Doxorubicin
Lymphoma, large-cell
Lymphatic Diseases
Lymphoma, Large-Cell, Anaplastic
Anaplastic large cell lymphoma
Fluorides
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Follicular lymphoma

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antimitotic Agents
Antibiotics, Antineoplastic

Hormones
Glucocorticoids
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Tubulin Modulators
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Alkylating Agents

ClinicalTrials.gov processed this record on January 16, 2009