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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
Not Enrolling

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Trial Information

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



- 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


- 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


- 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



- 16 and over

Performance status

- CTC 0-2

Life expectancy

- Not specified


- Absolute neutrophil count ≥ 1,000/mm^3

- Platelet count ≥ 100,000/mm^3


- Bilirubin ≤ 2 mg/dL

- AST ≤ 2 times upper limit of normal


- Creatinine ≤ 2 mg/dL


- LVEF normal by echocardiogram or MUGA


- DLCO ≥ 60% with no symptomatic pulmonary disease


- HIV negative

- Not pregnant or nursing

- Fertile patients must use effective contraception


Biologic therapy

- No concurrent pegfilgrastim


- 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)


- See Disease Characteristics

- No prior radiotherapy for Hodgkin's lymphoma


- Not specified


- No other prior treatment for Hodgkin's lymphoma

Type of Study:


Study Design:

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

Outcome Measure:


Outcome Time Frame:

24 weeks

Safety Issue:


Principal Investigator

David J. Straus, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

May 2004

Completion Date:

May 2011

Related Keywords:

  • Lymphoma
  • stage I adult Hodgkin lymphoma
  • stage II adult Hodgkin lymphoma
  • Hodgkin Disease
  • Lymphoma



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