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Phase II Trial of Doxorubicin, Vinblastine, and Gemcitabine (AVG) Chemotherapy for Non-Bulky Stage I and II Hodgkin's Lymphoma


Phase 2
16 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

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