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AzTrials

LymphomaNCT00110006

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

A study testing rituximab, cyclophosphamide and doxorubicin hydrochloride in people with Lymphoma, run by Case Comprehensive Cancer Center.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma
What is being tested?
rituximab, cyclophosphamide and doxorubicin hydrochloride
How many people
0 participants
Where
No sites listed yet
Study dates
Dec 2004to not given
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

About this study

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

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.

Read the 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.

Conditions
Lymphoma
Keywords
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
Medical subject headings
Lymphoma, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Mantle-Cell, Lymphoma, Large-Cell, Anaplastic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rituximabBiological

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

  • cyclophosphamideDrug

    Cyclophosphamide IV over 30 minutes. Treatment repeats every 14-21 days for up to 4 courses in the absence of unacceptable toxicity.

  • doxorubicin hydrochlorideDrug

    Doxorubicin IV over 5 minutes. Treatment repeats every 14-21 days for up to 4 courses in the absence of unacceptable toxicity.

  • prednisoneDrug

    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 sulfateDrug

    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.

  • positron emission tomographyProcedure or surgery

    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.

  • fludeoxyglucose F 18Radiation

    Patients receive fludeoxyglucose F 18 (^18FDG) IV.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

  2. Overall survival at 7-10 days after R-CHOP, and after completion of study treatment

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

  3. Disease-free survival at 7-10 days after R-CHOP, and after completion of study treatment

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2005 (estimated)
  2. Study startDec 2004

Why it stopped: No accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00110006
Sponsor's protocol ID
CASE2404
Other IDs
P30CA043703, CASE-CWRU-2404, CWRU-100401
Status last verified
Jun 2010
First submitted
3 May 2005
Last updated
11 Jun 2010
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing rituximab, cyclophosphamide and doxorubicin hydrochloride in people with Lymphoma, run by Case Comprehensive Cancer Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 11 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete remission as measured by positron emission tomography (PET) at 7-10 days after R-CHOP, and after completion of study treatment (time frame: at 7-10 days after R-CHOP, and after completion of study treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00110006.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2010.

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