Fludeoxyglucose F 18 Positron Emission Tomography in Predicting Risk of Relapse in Patients With Non-Hodgkin's Lymphoma Who Are Undergoing Combination Chemotherapy With or Without Autologous Stem Cell or Bone Marrow Transplant

NCT00238368 | Completed Phase 2

• 4 other identifiers: J0348 CDR0000445618P30CA006973JHOC-J0348JHOC-03082605
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Giving chemotherapy with an autologous stem cell or bone marrow transplant may allow more chemotherapy to be given so that more cancer cells are killed. Procedures, such as fludeoxyglucose F 18 positron emission tomography (FDG-PET) (done during chemotherapy) may help doctors predict a patient's risk of relapse and help plan the best treatment. PURPOSE: This phase II trial is studying how well FDG-PET works in predicting risk of relapse in patients with aggressive non-Hodgkin's lymphoma who are undergoing combination chemotherapy with or without autologous stem cell or bone marrow transplant.

Conditions

Lymphoma

Keywords

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 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; anaplastic large cell lymphoma; stage I adult T-cell leukemia/lymphoma; stage II adult T-cell leukemia/lymphoma; stage III adult T-cell leukemia/lymphoma; stage IV adult T-cell leukemia/lymphoma

Outcome Measures

Primary Outcomes (1)

• 2-year event free survival

Secondary Outcomes (3)

• Overall survival

• Predictive value of early negative fludeoxyglucose F 18 positron emission tomography (FDG-PET)

• Correlation of International Prognostic Index risk category with FDG-PET results and overall outcome

Interventions

filgrastim BIOLOGICAL

rituximab BIOLOGICAL

busulfan DRUG

cisplatin DRUG

cyclophosphamide DRUG

cytarabine DRUG

doxorubicin hydrochloride DRUG

etoposide DRUG

methylprednisolone DRUG

prednisone DRUG

vincristine sulfate DRUG

autologous bone marrow transplantation PROCEDURE

peripheral blood stem cell transplantation PROCEDURE

positron emission tomography PROCEDURE

fludeoxyglucose F 18 RADIATION

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed aggressive non-Hodgkin's lymphoma of 1 of the following subtypes: * Diffuse large B-cell lymphoma * Mediastinal (thymic) B-cell lymphoma * Grade 3 follicular lymphoma * Anaplastic large cell lymphoma * Peripheral T-cell lymphoma * Must have adequate staging of disease by the following techniques: * CT scan or MRI of affected sites * Bone marrow biopsy (in cases where results influence the duration of chemotherapy only) * Lumbar puncture (if clinically indicated) * Stage I-IV disease * Any International Prognostic Index risk category * Radiographically measurable disease * None of the following aggressive non-Hodgkin's subtypes are allowed: * Mantle cell lymphoma * Lymphoblastic lymphoma * Burkitt's lymphoma * Mycosis fungoides/Sezary's syndrome * HTLV-1-associated T-cell leukemia/lymphoma * Primary CNS lymphoma * HIV-associated lymphoma * Transformed lymphomas * No prior diagnosis of another hematologic malignancy * No known progressive disease during prior first-line chemotherapy * No active CNS involvement by lymphoma, except CNS involvement at diagnosis that is previously treated and in remission PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-4 (0-2 for peripheral blood stem cell \[PBSC\] or bone marrow transplantation \[BMT\] patients) Life expectancy * Not specified Hematopoietic * Absolute neutrophil count \> 1,000/mm\^3\* * Platelet count ≥ 75,000/mm\^3 NOTE: \*PBSC or BMT patients only Hepatic * Bilirubin ≤ 2.0 mg/dL unless due to Gilbert's disease or lymphoma\* * No known significant hepatic dysfunction that is not expected to improve and would preclude PBSC or BMT NOTE: \*PBSC or BMT patients only Renal * Creatinine ≤ 2.0 mg/dL\* * No known significant renal dysfunction that is not expected to improve and would preclude PBSC or BMT NOTE: \*PBSC or BMT patients only Cardiovascular * Ejection fraction ≥ 45% by echocardiogram or MUGA\* * No known significant cardiac dysfunction that is not expected to improve and would preclude PBSC or BMT NOTE: \*PBSC or BMT patients only; a cardiology consult and evaluation may override ejection fraction criterion Pulmonary * FEV\_1 and FVC ≥ 50% of predicted for patients who have not received thoracic or mantle radiotherapy (75% of predicted for patients who have received thoracic or mantle radiotherapy)\* * No known significant pulmonary dysfunction that is not expected to improve and would preclude PBSC or BMT NOTE: \*PBSC or BMT patients only Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other malignancy within the past 3 years except carcinoma in situ of the cervix or nonmelanoma skin cancer * No known HIV positivity OR HIV negative (for PBSC or BMT patients only) * No serious illness that would preclude study participation * No contraindication to autologous BMT PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics * No more than 3 prior courses of chemotherapy for lymphoma Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

MeSH Terms

Conditions

Lymphoma; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular; Lymphoma, Large-Cell, Anaplastic; Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Filgrastim; Rituximab; Busulfan; Cisplatin; Cyclophosphamide; Cytarabine; Doxorubicin; Etoposide; Methylprednisolone; Prednisone; Vincristine; Peripheral Blood Stem Cell Transplantation; Magnetic Resonance Spectroscopy; Fluorodeoxyglucose F18; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma, T-Cell; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia; Hematologic Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Pregnadienediols; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Deoxyglucose; Deoxy Sugars

Study Officials

• Lode J. Swinnen, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: DIAGNOSTIC
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2005
• First Posted: October 13, 2005
• Study Start: February 1, 2004
• Primary Completion: September 17, 2007
• Study Completion: September 17, 2007
• Last Updated: November 6, 2017

Record last verified: 2017-11

Locations

US (1)