Sandra Horning
Gemcitabine and Hodgkin's Disease Chemotherapy Followed by Peripheral Blood Stem Cell Rescue for Hodgkin's Disease
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
Phase II Gemcitabine + HD Chemotherapy Followed by PBSC Rescue for HD
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: Gemcitabine
- Drug: Vinorelbine
- Drug: Carmustine
- Drug: Etoposide
- Drug: Cyclophosphamide
- Procedure: Autologous hematopoietic stem cell transplantation.
Phase:
Phase 2Eligibility
Ages Eligible for Study:
18 years to 70 yearsGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key 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:
o stage IV extranodal disease at relapse
"B" symptoms
o 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):
o 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.
Key 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.
Additional Study Details
Official Title:
Gemcitabine and High Dose Chemotherapy Followed by Peripheral Blood Stem Cell Rescue for Relapsed or Resistant Hodgkin's DiseaseAnticipated start date:
9/4/2001Lead Sponsor:
Stanford UniversityCollaborator(s):
- NIH (PPG)
- NIH
Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
Safety/EfficacyPrimary Outcomes:
- Estimate freedom from progression, event-free survival and overall survival of the gemcitabine/vinorelbine and high dose chemotherapy regimen with AHCT among patients with refractory or recurrent Hodgkin?s disease.
- 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)
- Assess the pulmonary toxicity of a novel preparatory regimen containing gemcitabine, vinorelbine, carmustine, etoposide and cyclophosphamide in a phase II study.
Secondary Outcomes:
- Measurement of effect between day 42 and day 60, prior to commencement of radiotherapy (CR, CCR, PR, SD, PD, Relapse)
- Duration of Response
Total Number to be Enrolled:
72Total Number to be Enrolled at Stanford:
72More Information
Secondary ID(s):
- 1 K23 AI52413-01A1
- 77535
- BMT135
- CA 49605
- NCT00388349
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
9/23/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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