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LymphomaPhase 2NCT00086801

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

A Phase 2 study testing doxorubicin hydrochloride, gemcitabine hydrochloride and vinblastine in people with Lymphoma, run by Alliance for Clinical Trials in Oncology at 47 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Lymphoma
What is being tested?
doxorubicin hydrochloride, gemcitabine hydrochloride and vinblastine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
104 participants
Where
47 sitesUnited States
Study dates
May 2004to May 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult
  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.
  1. No prior treatment (chemotherapy or radiation therapy) for Hodgkin lymphoma.
  2. 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
  1. Age ≥ 16 years
  2. Performance status 0-2
  3. LVEF by ECHO or MUGA within institutional normal limits
  4. DLCO ≥ 60% with no symptomatic pulmonary disease
  5. 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.
  6. 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.
  7. 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

Trial locations and contacts

47 sites in 1 country.

47 sites in 1 country

United States47 sites

  • Greenebaum Cancer Center at University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Mountainview Medical

    Berlin Corners, Vermont, 05602

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Dana-Farber/Brigham and Women's Cancer Center

    Boston, Massachusetts, 02115

  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Fletcher Allen Health Care - University Health Center Campus

    Burlington, Vermont, 05401

  • Iowa Blood and Cancer Care

    Cedar Rapids, Iowa, 52402

  • St. Luke's Hospital

    Cedar Rapids, Iowa, 52402

  • Mercy Regional Cancer Center at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599-7295

  • Presbyterian Cancer Center at Presbyterian Hospital

    Charlotte, North Carolina, 28233-3549

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Missouri Cancer Associates

    Columbia, Missouri, 65201

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

    Columbus, Ohio, 43210-1240

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Union Hospital Cancer Center at Union Hospital

    Elkton MD, Maryland, 21921

  • Charles R. Wood Cancer Center at Glens Falls Hospital

    Glens Falls, New York, 12801

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • Wayne Radiation Oncology

    Goldsboro, North Carolina, 27534

  • Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center

    Grand Island, Nebraska, 68803

  • Bon Secours St. Francis Health System

    Greenville, South Carolina, 29601

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • Lenoir Memorial Cancer Center

    Kinston, North Carolina, 28501

  • Howard Community Hospital at Howard Regional Health System

    Kokomo, Indiana, 46904

  • Center for Cancer Therapy at LaPorte Hospital and Health Services

    La Porte, Indiana, 46350

  • Beebe Medical Center

    Lewes, Delaware, 19958

  • University of Minnesota Medical Center - Fairview

    Minneapolis, Minnesota, 55455

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • New York Weill Cornell Cancer Center at Cornell University

    New York, New York, 10021

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • Great Plains Regional Medical Center

    North Platte, Nebraska, 69101-6598

  • UNMC Eppley Cancer Center at the University of Nebraska Medical Center

    Omaha, Nebraska, 68198-6805

  • Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph

    Saint Joseph, Michigan, 49085

  • UCSF Comprehensive Cancer Center

    San Francisco, California, 94115

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Saint Joseph Regional Medical Center

    South Bend, Indiana, 46617

  • Siteman Cancer Center at Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • CCOP - Hematology-Oncology Associates of Central New York

    Syracuse, New York, 13057

  • SUNY Upstate Medical University Hospital

    Syracuse, New York, 13210

  • Community General Hospital

    Syracuse, New York, 13215

  • Cancer Institute of New Jersey at Cooper - Voorhees

    Voorhees Township, New Jersey, 08043

  • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • Walter Reed Army Medical Center

    Washington D.C., District of Columbia, 20307-5001

  • Wilson Medical Center

    Wilson, North Carolina, 27893-3428

  • Wake Forest University Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157-1096

Other trials in United States

About this study

Official title: Phase II Trial of Doxorubicin, Vinblastine, and Gemcitabine (AVG) Chemotherapy for Non-Bulky Stage I and II Hodgkin's Lymphoma

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.

Read the 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.

Conditions
Lymphoma
Being tested
doxorubicin hydrochloride, gemcitabine hydrochloride, vinblastine, fludeoxyglucose F 18 positron-emission tomography (PET) scan, CT scan
Keywords
stage I adult Hodgkin lymphoma, stage II adult Hodgkin lymphoma
Medical subject headings
Lymphoma, Hodgkin Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00086801
Study groupRoleWhat they receive
doxorubicin + vinblastine + gemcitabineExperimentalPatients 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.
Receives: Drug: doxorubicin hydrochloride; Drug: gemcitabine hydrochloride; Drug: vinblastine; Procedure: fludeoxyglucose F 18 positron-emission tomography (PET) scan; Procedure: CT scan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2004 (estimated)
  2. Study startMay 2004
  3. Primary completionMar 2007
  4. Study completionMay 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
104 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00086801
Sponsor's protocol ID
CALGB-50203
Other IDs
U10CA031946, CALGB-50203, CDR0000370870
Status last verified
Jun 2016
First submitted
8 Jul 2004
Last updated
1 Jul 2016
Results posted
No
Data monitoring committee
No

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.

  • Straus DJ, Johnson JL, LaCasce AS, Bartlett NL, Kostakoglu L, Hsi ED, Schoder H, Hall NC, Jung SH, Canellos GP, Schwartz LH, Takvorian RW, Juweid ME, Cheson BD; Cancer and Leukemia Group B. Doxorubicin, vinblastine, and gemcitabine (CALGB 50203) for stage I/II nonbulky Hodgkin lymphoma: pretreatment prognostic factors and interim PET. Blood. 2011 May 19;117(20):5314-20. doi: 10.1182/blood-2010-10-314260. Epub 2011 Feb 25.

    PubMed 21355087

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing doxorubicin hydrochloride, gemcitabine hydrochloride and vinblastine in people with Lymphoma, run by Alliance for Clinical Trials in Oncology at 47 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00086801, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2016.

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