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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00388349
First received: October 12, 2006
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

Phase II Gemcitabine + HD Chemotherapy Followed by PBSC Rescue for HD


Condition Intervention Phase
Lymphoma, Hodgkin Disease
Lymphoma
Hodgkin Disease
Lymphoma: Hodgkin
Drug: Gemcitabine
Drug: Vinorelbine
Drug: Carmustine
Drug: Etoposide
Drug: Cyclophosphamide
Procedure: Autologous hematopoietic stem cell transplantation.
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Estimate freedom from progression,event-free survival and overall survival of the gemcitabine/vinorelbine and high dose chemotherapy regimen with AUTOLOGOUS HEMATOPOIETIC PROGENITOR CELL TRA among patients with refractory or recurrent Hodgkin's disease. [ Time Frame: May 2012 ] [ Designated as safety issue: No ]
  • Assess non-hematologic toxicity and determine phase II dose of gemcitabine in combination with vinorelbine followed by high dose carmustine, etoposide and cyclophosphamide and autologous hematopoietic stem cell transplantation (AHCT) [ Time Frame: completed June 2005 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assess the pulmonary toxicity of a novel preparatory regimen containing gemcitabine, vinorelbine, carmustine, etoposide and cyclophosphamide in a phase II study. [ Time Frame: September 2010 ] [ Designated as safety issue: Yes ]

Enrollment: 146
Study Start Date: September 2001
Study Completion Date: September 2010
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Detailed Description:

To assess the non-hematologic toxicity and determine the phase II dose of gemcitabine in combination with vinorelbine followed by carmustine, etoposide and cyclophosphamide and autologous hematopoietic stem cell transplantation.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:Histologically proven recurrent or refractory Hodgkin's lymphoma reviewed at Stanford University Medical Center. The diagnosis should be made by excisional biopsy whenever possible. Biopsy of refractory or recurrent disease is preferred but fine needle aspirate with supportive morphology and immunohistochemistry is acceptable for recurrent or persistent gallium-positive or positron emission tomography (PET)-positive radiographic disease when major surgery would be required.

  • Age < 70 years
  • ECOG performance status 0-3.
  • One or more adverse risk factors for Phase I study:

    • 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%) or progression during induction or salvage therapy.
  • Patients will be eligible regardless of risk factors for Phase II study.
  • Computerized tomography scan of the chest, abdomen and pelvis within 4 weeks of registration. Assessment of response to last chemotherapy prior to registration is mandatory.
  • Gallium scan or PET scan determination 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 are strongly advised to use an accepted and effective method of birth control.
  • Patients must have a pretreatment serum bilirubin < 2 x the institutional ULN, a serum creatinine < 2 x the institutional ULN and measured or estimated creatinine clearance > 60 cc/min by the following formula (all tests must be performed within 28 days prior to registration):

    • Estimated Creatinine Clearance = (140 age)X WT(kg) X 0.85 if female X creatinine (mg/dl)
  • Patients must have an EKG within 42 days prior to registration that shows no significant abnormalities that are suggestive of active cardiac disease.
  • Patients over age 50, those who have received chest irradiation or a total of 300 mg/m2 of doxorubicin, or those with any history of cardiac disease must have a radionuclide ejection fraction within 42 days of registration. If the ejection fraction is 40-50%, the patient will have a cardiology consult.
  • Patients must have a corrected diffusion capacity >55%.
  • Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.

Exclusion Criteria:Patients known to be human immunodeficiency virus (HIV)-positive because the concern for opportunistic infection and hematologic reserve are considered to be significantly greater in this population. The antibody test for HIV must be performed within 42 days of registration.

  • No chemotherapy other than corticosteroids should be administered within 2 weeks of the initiation of protocol therapy.
  • Pregnant or breast-feeding women due to the known birth defects association with the treatments used in this study.
  • Patients requiring therapy for coronary artery disease, cardiomyopathy, dysrhythmia, or congestive heart failure.
  • Patients over age 50, those who have received chest irradiation or a total of 300 mg/m^2 of doxorubicin, or those with any history of cardiac disease must have a radionuclide ejection fraction within 42 days of registration. If the ejection fraction is <40% the patient is not eligible.
  • Patients with known allergy to etoposide or a history of Grade 3 hemorrhagic cystitis with cyclophosphamide.
  • Patients with > grade 2 sensory or motor peripheral neuropathy from prior vinca alkaloid use.
  • No prior malignancy is allowed except 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 five years. Patients with a prior diagnosis of non-Hodgkin's lymphoma are not eligible.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00388349

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Sally Arai Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00388349     History of Changes
Other Study ID Numbers: BMT135, 1 K23 AI52413-01A1, 77535, CA 49605
Study First Received: October 12, 2006
Last Updated: August 27, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Cyclophosphamide
Gemcitabine
Alkylating Agents
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014