Status:
COMPLETED
Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage I or Stage II Hodgkin's Lymphoma
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lymphoma
Eligibility:
All Genders
16+ years
Phase:
PHASE2
Brief 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...
Detailed Description
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 gemcitab...
Eligibility Criteria
Inclusion
- Documentation of Disease:
- 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.
- 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.
- 3 Bone marrow biopsy is required for pretreatment evaluation. Bilateral biopsies are preferred but not required.
- No prior treatment (chemotherapy or radiation therapy) for Hodgkin lymphoma.
- 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
- Age ≥ 16 years
- Performance status 0-2
- LVEF by ECHO or MUGA within institutional normal limits
- DLCO ≥ 60% with no symptomatic pulmonary disease
- 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.
- 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.
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT00086801
Start Date
May 1 2004
End Date
May 1 2011
Last Update
July 1 2016
Active Locations (47)
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1
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115
2
Beebe Medical Center
Lewes, Delaware, United States, 19958
3
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
4
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007