Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage I or Stage II Hodgkin's Lymphoma

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as doxorubicin, vinblastine, and gemcitabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating patients with newly diagnosed stage I or stage II Hodgkin's lymphoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Doxorubicin; Fluorodeoxyglucose F18; Gemcitabine; Liposomal doxorubicin; Vinblastine

Criteria

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