Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| P30CA043703 | U.S. NIH Grant/Contract | View source | |
| CASE-CWRU-2404 | Other Identifier | Case Comprehensive Cancer Center | |
| CWRU-100401 |
Not provided
Not provided
Not provided
No accrual
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
OBJECTIVES:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rituximab | Biological | Rituximab IV over 3-6 hours. Treatment repeats every 14-21 days for up to 4 courses in the absence of unacceptable toxicity. | ||
| cyclophosphamide | Drug | Cyclophosphamide IV over 30 minutes. Treatment repeats every 14-21 days for up to 4 courses in the absence of unacceptable toxicity. | ||
| doxorubicin hydrochloride | Drug | Doxorubicin IV over 5 minutes. Treatment repeats every 14-21 days for up to 4 courses in the absence of unacceptable toxicity. | ||
| prednisone | Drug | 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 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| 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 | |
| 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 |
Not provided
Not provided
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:
The following subtypes are not allowed:
Adequate staging of lymphoma by any of the following methods:
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
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Panayiotis Savvides, MD | Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | Study Chair |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| positron emission tomography | Procedure | 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 18 | Radiation | Patients receive fludeoxyglucose F 18 (^18FDG) IV. |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D008224 | Lymphoma, Follicular |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D020522 | Lymphoma, Mantle-Cell |
| D017728 | Lymphoma, Large-Cell, Anaplastic |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D016393 | Lymphoma, B-Cell |
| D016399 | Lymphoma, T-Cell |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D011241 | Prednisone |
| D014750 | Vincristine |
| D009682 | Magnetic Resonance Spectroscopy |
| D019788 | Fluorodeoxyglucose F18 |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D003847 | Deoxyglucose |
| D003837 | Deoxy Sugars |
Not provided
Not provided