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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00086801
First received: July 8, 2004
Last updated: June 30, 2016
Last verified: June 2016
  Purpose

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.


Condition Intervention Phase
Lymphoma
Drug: doxorubicin hydrochloride
Drug: gemcitabine hydrochloride
Drug: vinblastine
Procedure: fludeoxyglucose F 18 positron-emission tomography (PET) scan
Procedure: CT scan
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Doxorubicin, Vinblastine, and Gemcitabine (AVG) Chemotherapy for Non-Bulky Stage I and II Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Response [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 104
Study Start Date: May 2004
Study Completion Date: May 2011
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: doxorubicin + vinblastine + gemcitabine

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.

Drug: doxorubicin hydrochloride
given IV
Drug: gemcitabine hydrochloride
given IV
Drug: vinblastine
given IV
Procedure: fludeoxyglucose F 18 positron-emission tomography (PET) scan Procedure: CT scan

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 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.

  Eligibility

Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00086801

  Show 47 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
Study Chair: David Straus, MD Memorial Sloan Kettering Cancer Center
  More Information

Publications:
Kostakoglu L, Straus DJ, Schöder H, et al.: Validation of the International Harmonization Project (IHP) Guidelines in early stage Hodgkin lymphoma (HL) treated with adriamycin, vinblastine and gemcitabine (AVG) (CALGB 50203): early results. [Abstract] Blood 112 (11): A-1460, 2008.
Straus D, LaCase A, Juweid M, et al.: Doxorubicin, vinblastine and gemcitabine (AVG), a novel regimen excluding bleomycin for the treatment of early stage Hodgkin lymphoma (HL): results of CALGB 50203. [Abstract] Blood 110 (11): A-214, 2007.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00086801     History of Changes
Other Study ID Numbers: CALGB-50203  U10CA031946  CDR0000370870 
Study First Received: July 8, 2004
Last Updated: June 30, 2016
Health Authority: United States: Federal Government

Keywords provided by Alliance for Clinical Trials in Oncology:
stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma

Additional relevant MeSH terms:
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Gemcitabine
Doxorubicin
Liposomal doxorubicin
Vinblastine
Fluorodeoxyglucose F18
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on August 30, 2016