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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):
Cancer and Leukemia Group B
ClinicalTrials.gov Identifier:
NCT00086801
First received: July 8, 2004
Last updated: March 15, 2012
Last verified: March 2011
History of Changes
  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
 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:

U.S. FDA Resources

Further study details as provided by Cancer and Leukemia Group B:

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)
Intervention Details:
    Drug: doxorubicin hydrochloride
    given IV
    Drug: gemcitabine hydrochloride
    given IV
    Drug: vinblastine
    given IV
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.

PROJECTED ACCRUAL: A total of 98 patients will be accrued for this study within 3 years.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 16 and over

Performance status

  • CTC 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,000/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin ≤ 2 mg/dL
  • AST ≤ 2 times upper limit of normal

Renal

  • Creatinine ≤ 2 mg/dL

Cardiovascular

  • LVEF normal by echocardiogram or MUGA

Pulmonary

  • DLCO ≥ 60% with no symptomatic pulmonary disease

Other

  • HIV negative
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent pegfilgrastim

Chemotherapy

  • 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)

Radiotherapy

  • See Disease Characteristics
  • No prior radiotherapy for Hodgkin's lymphoma

Surgery

  • Not specified

Other

  • No other prior treatment for Hodgkin's lymphoma
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00086801

  Show 47 Study Locations
Sponsors and Collaborators
Cancer and Leukemia Group B
National Cancer Institute (NCI)
Investigators
Study Chair: David J. Straus, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Cancer and Leukemia Group B
ClinicalTrials.gov Identifier: NCT00086801     History of Changes
Other Study ID Numbers: CDR0000370870, U10CA031946, CALGB-50203
Study First Received: July 8, 2004
Last Updated: March 15, 2012
Health Authority: United States: Federal Government

Keywords provided by Cancer and Leukemia Group B:
stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma

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

ClinicalTrials.gov processed this record on May 16, 2013