Phase II Trial of Doxorubicin, Vinblastine, and Gemcitabine (AVG) Chemotherapy for Non-Bulky Stage I and II Hodgkin's Lymphoma
16 Years
N/A
Both
Lymphoma
Trial Information
Phase II Trial of Doxorubicin, Vinblastine, and Gemcitabine (AVG) Chemotherapy for Non-Bulky Stage I and II Hodgkin's Lymphoma
OBJECTIVES:
Primary
- Determine the complete response rate in patients with newly diagnosed stage IA, IB,
IIA, or IIB non-bulky Hodgkin's lymphoma treated with doxorubicin, vinblastine, and
gemcitabine.
Secondary
- Determine the event-free survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Determine whether fludeoxyglucose F 18 positron-emission tomography scanning is useful
in predicting clinical relapse and determining the presence of residual disease in
these patients after treatment with this regimen.
OUTLINE: This is a multicenter study.
Patients receive doxorubicin IV over 3-5 minutes, vinblastine IV over 3-5 minutes, and
gemcitabine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6
courses in the absence of disease progression or unacceptable toxicity.
Patients undergo fludeoxyglucose F 18 positron-emission tomography (PET) scanning and CT
scan before treatment and after courses 2 and 6 of therapy to assess response. Patients with
a positive PET scan after completion of study therapy may undergo biopsy. A PET scan is
performed 3 months later if biopsy is negative or biopsy is unable to be performed.
Patients are followed every 3 months for 1 year, every 4 months for 2 years, every 6 months
for 2 years, and then annually for 5 years.
PROJECTED ACCRUAL: A total of 98 patients will be accrued for this study within 3 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed non-bulky Hodgkin's lymphoma
- Clinical stage IA, IB, IIA, or IIB
- "E" extensions allowed if all other criteria are met
- Measurable disease
- At least 1 unidimensionally measurable lesion > 2 cm by CT scan or MRI OR ≥ 1.5
cm by spiral CT scan
- The following are considered non-measurable:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural or pericardial effusion
- Inflammatory breast disease
- Lymphangitis cutis or pulmonis
- Abdominal masses not confirmed and followed by imaging techniques
- Cystic lesions
- Lesions in a previously irradiated area
- Bone marrow biopsy required
- No mediastinal mass that is > one-third of the maximum intrathoracic diameter on a
standing posterior-anterior chest x-ray
- No peripheral or retroperitoneal adenopathy > 10 cm in its largest diameter
- No nodular lymphocyte predominant Hodgkin's lymphoma
PATIENT CHARACTERISTICS:
Age
- 16 and over
Performance status
- CTC 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,000/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- Bilirubin ≤ 2 mg/dL
- AST ≤ 2 times upper limit of normal
Renal
- Creatinine ≤ 2 mg/dL
Cardiovascular
- LVEF normal by echocardiogram or MUGA
Pulmonary
- DLCO ≥ 60% with no symptomatic pulmonary disease
Other
- HIV negative
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent pegfilgrastim
Chemotherapy
- No prior chemotherapy for Hodgkin's lymphoma
- No other concurrent chemotherapy
Endocrine therapy
- No concurrent hormone therapy except steroids for adrenal failure or hormones for
non-disease-related conditions (e.g., insulin for diabetes)
Radiotherapy
- See Disease Characteristics
- No prior radiotherapy for Hodgkin's lymphoma
Surgery
- Not specified
Other
- No other prior treatment for Hodgkin's lymphoma
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response
Outcome Time Frame:
24 weeks
Safety Issue:
No
Principal Investigator
David J. Straus, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000370870
NCT ID:
NCT00086801
Start Date:
May 2004
Completion Date:
May 2011
Related Keywords:
- Lymphoma
- stage I adult Hodgkin lymphoma
- stage II adult Hodgkin lymphoma
- Hodgkin Disease
- Lymphoma
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
| University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
| CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
| Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
| Memorial Hospital of South Bend | South Bend, Indiana 46601 |
| CCOP - Greenville | Greenville, South Carolina 29615 |
| CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
| Saint Joseph Regional Medical Center | South Bend, Indiana 46617 |
| Siteman Cancer Center at Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | Columbus, Ohio 43210-1240 |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
| UCSF Comprehensive Cancer Center | San Francisco, California 94115 |
| Fletcher Allen Health Care - University Health Center Campus | Burlington, Vermont 05401 |
| University of Minnesota Medical Center - Fairview | Minneapolis, Minnesota 55455 |
| SUNY Upstate Medical University Hospital | Syracuse, New York 13210 |
| Presbyterian Cancer Center at Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
| Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
| CCOP - Hematology-Oncology Associates of Central New York | East Syracuse, New York 13057 |
| Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
| Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore, Maryland 21201 |
| UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Omaha, Nebraska 68198-7680 |
| Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph | Saint Joseph, Michigan 49085 |
| New York Weill Cornell Cancer Center at Cornell University | New York, New York 10021 |
| Lenoir Memorial Cancer Center | Kinston, North Carolina 28503-1678 |
| Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Washington, District of Columbia 20007 |
| Elkhart General Hospital | Elkhart, Indiana 46515 |
| Beebe Medical Center | Lewes, Delaware 19958 |
| Howard Community Hospital at Howard Regional Health System | Kokomo, Indiana 46904 |
| Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte, Indiana 46350 |
| St. Luke's Hospital | Cedar Rapids, Iowa 52402 |
| Mercy Regional Cancer Center at Mercy Medical Center | Cedar Rapids, Iowa 52403 |
| Union Hospital Cancer Center at Union Hospital | Elkton MD, Maryland 21921 |
| Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center | Grand Island, Nebraska 68803 |
| Great Plains Regional Medical Center | North Platte, Nebraska 69101-6598 |
| Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees, New Jersey 08043 |
| Charles R. Wood Cancer Center at Glens Falls Hospital | Glens Falls, New York 12801 |
| Wayne Radiation Oncology | Goldsboro, North Carolina 27534 |
| Wilson Medical Center | Wilson, North Carolina 27893-3428 |
| Bon Secours St. Francis Health System | Greenville, South Carolina 29601 |
| Mountainview Medical | Berlin, Vermont 05602 |
| Missouri Cancer Associates | Columbia, Missouri 65201 |
| Dana-Farber/Brigham and Women's Cancer Center | Boston, Massachusetts 02115 |
| Iowa Blood and Cancer Care | Cedar Rapids, Iowa 52402 |
| Community General Hospital | Syracuse, New York 13215 |
