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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 InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
University of Chicago Cancer Research CenterChicago, Illinois  60637
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Memorial Hospital of South BendSouth Bend, Indiana  46601
CCOP - GreenvilleGreenville, South Carolina  29615
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
Siteman Cancer Center at Barnes-Jewish HospitalSaint Louis, Missouri  63110
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State UniversityColumbus, Ohio  43210-1240
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Fletcher Allen Health Care - University Health Center CampusBurlington, Vermont  05401
University of Minnesota Medical Center - FairviewMinneapolis, Minnesota  55455
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
CCOP - Hematology-Oncology Associates of Central New YorkEast Syracuse, New York  13057
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
UNMC Eppley Cancer Center at the University of Nebraska Medical CenterOmaha, Nebraska  68198-7680
Lakeland Cancer Care Center at Lakeland Hospital - St. JosephSaint Joseph, Michigan  49085
New York Weill Cornell Cancer Center at Cornell UniversityNew York, New York  10021
Lenoir Memorial Cancer CenterKinston, North Carolina  28503-1678
Lombardi Comprehensive Cancer Center at Georgetown University Medical CenterWashington, District of Columbia  20007
Elkhart General HospitalElkhart, Indiana  46515
Beebe Medical CenterLewes, Delaware  19958
Howard Community Hospital at Howard Regional Health SystemKokomo, Indiana  46904
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
St. Luke's HospitalCedar Rapids, Iowa  52402
Mercy Regional Cancer Center at Mercy Medical CenterCedar Rapids, Iowa  52403
Union Hospital Cancer Center at Union HospitalElkton MD, Maryland  21921
Saint Francis Cancer Treatment Center at Saint Francis Memorial Health CenterGrand Island, Nebraska  68803
Great Plains Regional Medical CenterNorth Platte, Nebraska  69101-6598
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Charles R. Wood Cancer Center at Glens Falls HospitalGlens Falls, New York  12801
Wayne Radiation OncologyGoldsboro, North Carolina  27534
Wilson Medical CenterWilson, North Carolina  27893-3428
Bon Secours St. Francis Health SystemGreenville, South Carolina  29601
Mountainview MedicalBerlin, Vermont  05602
Missouri Cancer AssociatesColumbia, Missouri  65201
Dana-Farber/Brigham and Women's Cancer CenterBoston, Massachusetts  02115
Iowa Blood and Cancer CareCedar Rapids, Iowa  52402
Community General HospitalSyracuse, New York  13215