Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage I or Stage 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.

1. Documentation of Disease:

1.1 Histologically documented Hodgkin lymphoma subclassified according to the WHO
modification of the Rye Classification and staged according to the modified Ann Arbor
Staging Classification system. Patients must have clinical stage IA, IB, IIA or IIB.
Patients with "E" extensions will be eligible if all other criteria have been met.
Nodular lymphocyte predominant Hodgkin lymphoma is excluded.

- Core biopsies are acceptable if they contain adequate tissue for primary
diagnosis and immunophenotyping. Fine needle aspirate (FNA) cytologies and bone
marrow biopsies as the sole means of diagnosis are not acceptable.

- Note: Failure to submit pathology slides within 60 days of patient registration
will result in patient being declared ineligible.

1.2 Patients may not have a mediastinal mass > 0.33 maximum intrathoracic diameter on
standing postero-anterior chest x-ray or peripheral or retroperitoneal adenopathy >
10 cm in its largest diameter.

1.3 Bone marrow biopsy is required for pretreatment evaluation. Bilateral biopsies
are preferred but not required.

2. No prior treatment (chemotherapy or radiation therapy) for Hodgkin lymphoma.

3. Measurable disease must be present either on physical examination or imaging studies.
Any tumor mass measurable in two dimensions and > 2 cm is acceptable (or 1.5 cm if
0.5 cm slices are used as in spiral CT scans). Lesions that are considered
intrinsically non-measurable include the following:

- bone lesions

- leptomeningeal disease

- ascites

- pleural/pericardial effusion

- inflammatory breast disease

- lymphangitis cutis/pulmonis

- abdominal masses that are not confirmed and followed by imaging techniques

- cystic lesions

- lesions that are situated in a previously irradiated area

4. Age ≥ 16 years

5. Performance status 0-2

6. LVEF by ECHO or MUGA within institutional normal limits

7. DLCO ≥ 60% with no symptomatic pulmonary disease

8. No known HIV infection. Patients with a history of intravenous drug abuse or any
behavior associated with an increased risk of HIV infection should be tested for
exposure to the HIV virus. Patients who test positive or who are known to be infected
are not eligible due to an increased risk of infection with this chemotherapy
regimen. An HIV test is not required for entry on this protocol, but is required if
the patient is perceived to be at risk.

9. Non-pregnant and non-lactating. Due to the teratogenic potential of the agents used
in this study, pregnant or nursing women may not be enrolled. Women and men of
reproductive potential should agree to use an effective means of birth control.

10. Initial Required Laboratory Data:

- ANC ≥ 1000/μL

- Platelet count ≥ 100,000/μL

- Serum Creatinine ≤ 2 mg/dL

- Bilirubin ≤ 2 mg/dL

- AST ≤ 2 x upper limit of normal