Know Cancer

or
forgot password

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


N/A
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Complete remission as measured by positron emission tomography (PET) at 7-10 days after R-CHOP, and after completion of study treatment

Outcome Time Frame:

at 7-10 days after R-CHOP, and after completion of study treatment

Safety Issue:

No

Principal Investigator

Panayiotis Savvides, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CASE2404

NCT ID:

NCT00110006

Start Date:

December 2004

Completion Date:

Related Keywords:

  • 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
  • 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
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location