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Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Hodgkin's Lymphoma

Information source: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lymphoma

Intervention: bleomycin (Biological); rituximab (Biological); ABVD regimen (Drug); dacarbazine (Drug); doxorubicin (Drug); vinblastine (Drug); DNA methylation analysis (Genetic); laboratory biomarker analysis (Other); fludeoxyglucose F 18 (Radiation)

Phase: Phase 2

Status: Completed

Sponsored by: Sidney Kimmel Comprehensive Cancer Center

Official(s) and/or principal investigator(s):
Yvette L. Kasamon, MD, Study Chair, Affiliation: Sidney Kimmel Comprehensive Cancer Center

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.

Clinical Details

Official title: Phase II Trial of Rituximab -ABVD for Classical Hodgkin's Disease

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Impact of Rituximab on Plasma DNA Biomarkers

Relationship Between Marker Detection and Clinical Outcome

Secondary outcome:

Event-free Survival

Addition of Information to Fludeoxyglucose F 18 Positron Emission Tomography (FDG-PET) by Plasma DNA Biomarkers

Detailed 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

City of Hope Comprehensive Cancer Center, Duarte, California 91010-3000, United States

Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa 52242-1009, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland 21231-2410, United States

Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: May 2006
Last updated: July 27, 2015

Page last updated: August 23, 2015

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