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Gemcitabine and Hodgkin's Disease Chemotherapy Followed by Peripheral Blood Stem Cell Rescue for Hodgkin's Disease

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ClinicalTrials.gov Identifier: NCT00388349
Recruitment Status : Completed
First Posted : October 16, 2006
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Sally Arai, Stanford University

Brief Summary:
This is a phase 2 study of gemcitabine + high-dose chemotherapy followed by peripheral blood stem cell (PBSC) rescue for Hodgkin's Disease

Condition or disease Intervention/treatment Phase
Hodgkin Disease Hodgkin's Lymphoma Lymphoma Drug: Gemcitabine Drug: Vinorelbine Drug: Carmustine Drug: Etoposide Drug: Cyclophosphamide Procedure: Autologous HCT Phase 2

Detailed Description:
To assess the non-hematologic toxicity and determine the phase 2 dose of gemcitabine in combination with vinorelbine followed by carmustine, etoposide and cyclophosphamide and autologous hematopoietic stem cell transplantation [aka peripheral blood stem cell (PBSC)].

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 146 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Gemcitabine and High-dose Chemotherapy Followed by Peripheral Blood Stem Cell Rescue for Relapsed or Resistant Hodgkin's Disease
Study Start Date : September 2001
Actual Primary Completion Date : March 2008
Actual Study Completion Date : September 2010

Arm Intervention/treatment
Experimental: Gemcitabine + Autologous HCT
Gemcitabine and high-dose chemotherapy followed by peripheral blood stem cell (PBSC) rescue. Chemotherapy includes Gemcitabine + Vinorelbine + Carmustine + Etoposide + Cyclophosphamide.
Drug: Gemcitabine
Other Name: Gemzar

Drug: Vinorelbine
Other Name: Navelbine

Drug: Carmustine
Other Name: BCNU

Drug: Etoposide
Other Name: Vepesid

Drug: Cyclophosphamide
Other Names:
  • Cytoxan
  • Neosar

Procedure: Autologous HCT
Other Name: Peripheral blood stem cell (PBSC) rescue

Primary Outcome Measures :
  1. Dose-limiting Toxicity of Gemcitabine Due to Non-hematologic Toxicity [ Time Frame: 6 months ]
    Reported as the number of Phase 1 participants by gemcitabine dose that experienced non-hematologic toxicity, ie, drug-related adverse events.

Secondary Outcome Measures :
  1. Pulmonary Toxicity (BCNU Pneumonitis) [ Time Frame: 2 years ]
    Pulmonary toxicity as assessed by the number of participants that experience BCNU pneumonitis, ie, pneumonitis due to carmustine (BCNU).

  2. Overall Survival (OS) [ Time Frame: 2 years ]
    Reports the percentage of participants surviving 6 months after PBSC infusion (transplant).

  3. Relapse Post-transplant [ Time Frame: 2 years ]
    Reports the percentage of participants that experienced relapse post-transplant.

  4. Survival Measures [ Time Frame: 2 years ]

    Reports the survival measures:

    • Freedom from progression (FFP)
    • Event-free survival (EFS)
    • Overall survival (OS)

    EFS and OS were estimated by Kaplan-Meier method

    Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically-proven recurrent or refractory Hodgkin's Disease (Hodgkin's lymphoma) on the basis of excisional biopsy whenever possible.
  • Age < 70 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 3.
  • Phase 1 study component only: 1 or more of the following adverse risk factors

    • Stage IV extranodal disease at relapse "B" symptoms
    • Failure to achieve minimal disease with most recent chemotherapy (single lymph nodes < 2 cm or >75% reduction in a bulky tumor mass and bone marrow involvement < 10%)
    • Progression during induction or salvage therapy
  • Phase 2 study component only: No risk factor criteria
  • Computerized tomography (CT) scan of the chest, abdomen and pelvis, with assessment of response to last chemotherapy, within 4 weeks of registration. Gallium scan or positron emission tomography (PET) scan confirmation of disease within 4 weeks of registration is highly recommended
  • Bone marrow biopsy and cytogenetic analysis within 8 weeks of registration
  • Women of child-bearing potential and sexually active males expected to use an accepted and effective method of birth control
  • Pretreatment serum bilirubin < 2 x the institutional upper limit of normal (ULN) (within 28 days prior to registration)
  • Serum creatinine < 2 x the institutional ULN (within 28 days prior to registration)
  • Measured or estimated creatinine clearance > 60 cc/min by the following formula (within 28 days prior to registration):

    • Estimated Creatinine Clearance = (140 age) x WT(kg) x 0.85 (if female) x creatinine (mg/dL)
  • Electrocardiogram (ECG) demonstrating no significant abnormalities suggestive of active cardiac disease (within 42 days prior to registration)
  • Patients over age 50, who have received chest irradiation or a total of 300 mg/m2 of doxorubicin or with any history of cardiac disease must have a radionuclide ejection fraction (within 42 days prior to registration). If the ejection fraction is 40 to 50%, the patient will have a cardiology consult
  • Corrected diffusion capacity > 55%
  • Written informed consent in accordance with institutional and federal guidelines

Exclusion Criteria:

  • Positive HIV antibody test (must be conducted within 42 days of registration)
  • No chemotherapy other than corticosteroids should be administered within 2 weeks of the initiation of protocol therapy
  • Pregnant
  • Breast-feeding
  • Requiring therapy for:

    • Coronary artery disease
    • Cardiomyopathy
    • Dysrhythmia, or
    • Congestive heart failure
  • Over age 50 and has received chest irradiation or a total of 300 mg/m^2 of doxorubicin
  • History of cardiac disease and the ejection fraction is < 40% (radionuclide ejection fraction must be within 42 days of registration)
  • Known allergy to etoposide
  • History of Grade 3 hemorrhagic cystitis with cyclophosphamide
  • History of grade 2 or greater sensory or motor peripheral neuropathy due to prior vinca alkaloid use
  • No prior malignancy (EXCEPTION: adequately treated basal cell or squamous cell skin cancer; in situ cervical cancer; or other cancer for which the patients has been disease-free for 5 years). Patients with a prior diagnosis of non-Hodgkin's lymphoma are not eligible.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00388349

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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
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Principal Investigator: Sally Arai, MD Stanford University
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Responsible Party: Sally Arai, Assistant Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT00388349    
Other Study ID Numbers: IRB-13511
1K23AI052413-01A1 ( U.S. NIH Grant/Contract )
BMT135 ( Other Identifier: OnCore )
First Posted: October 16, 2006    Key Record Dates
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors