Overview

This trial is active, not recruiting.

Condition lymphoma
Treatments bleomycin sulfate, rituximab, abvd regimen, dacarbazine, doxorubicin hydrochloride, vinblastine, dna methylation analysis, laboratory biomarker analysis, fludeoxyglucose f 18
Phase phase 2
Target CD20
Sponsor Sidney Kimmel Comprehensive Cancer Center
Collaborator National Cancer Institute (NCI)
Start date May 2006
End date May 2016
Trial size 50 participants
Trial identifier NCT00369681, J0615 CDR0000492792, JHOC-J0615, JHOC-NA_00002473, P30CA006973

Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. 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 rituximab together with combination chemotherapy may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating patients with newly diagnosed stage II, stage III, or stage IV Hodgkin's lymphoma.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Impact of rituximab on plasma DNA biomarkers
time frame: 5 years
Relationship between marker detection and clinical outcome
time frame: 5 years

Secondary Outcomes

Measure
Event-free survival
time frame: until death
Addition of information to fludeoxyglucose F 18 positron emission tomography (FDG-PET) by plasma DNA biomarkers
time frame: 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

DISEASE CHARACTERISTICS: - Histologically confirmed classical Hodgkin's lymphoma - No lymphocyte-predominant histology - Stage II, III, or IV disease - Newly diagnosed disease PATIENT CHARACTERISTICS: - Performance status 0-2 - Creatinine < 2.0 mg/dL - Bilirubin < 5 mg/dL - Not pregnant or nursing - No HIV positivity - Hepatitis B surface antigen negative - No active concurrent malignancy except for superficial nonmelanoma skin cancer or cervical carcinoma in situ PRIOR CONCURRENT THERAPY: - No prior chemotherapy or radiotherapy for Hodgkin's lymphoma - Steroids allowed if medically required before chemotherapy initiation

Additional Information

Official title Phase II Trial of Rituximab -ABVD for Classical Hodgkin's Disease
Description OBJECTIVES: Primary - Investigate plasma DNA biomarkers, including plasma clonal immunoglobulin DNA, tumor suppressor gene methylation, and Epstein-Barr virus DNA, in patients receiving rituximab and doxorubicin hydrochloride, bleomycin, vinblastine, and dacarbazine (ABVD) for newly diagnosed stage II-IV classical Hodgkin's lymphoma. - Characterize the impact of rituximab on these markers. - Characterize the relationship between marker detection and clinical outcome. Secondary - Estimate the event-free survival of patients with newly diagnosed Hodgkin's lymphoma treated with rituximab and ABVD. - Assess the presence of Hodgkin's lymphoma stem cells in peripheral blood mononuclear cells at baseline, after treatment with rituximab, and after treatment with ABVD. - Assess whether plasma DNA biomarkers add information to fludeoxyglucose F 18 positron emission tomography (FDG-PET) in assessing tumor response. OUTLINE: Patients receive doxorubicin hydrochloride IV, vinblastine IV, bleomycin IV, and dacarbazine IV (ABVD) on days 1 and 15 of all courses. Patients also receive rituximab IV on days -6, 1, 8, 15, and 22 of ABVD course 1 and on day 1 only of ABVD courses 2, 4, and 6. Treatment repeats every 28 days for 6-8 courses in the absence of disease progression or unacceptable toxicity. Patients with bulky disease may undergo radiotherapy. Plasma samples are obtained during treatment for investigation of tumor markers (e.g., immunoglobulin rearrangement, patterns of DNA methylation, and the presence of Epstein-Barr virus DNA). Patients undergo fludeoxyglucose F18 positron emission tomography periodically during the study. PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center.