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

Lymphoma Clinical Trial

Official title:

Gemcitabine and High Dose Chemotherapy Followed by Peripheral Blood Stem Cell Rescue for Relapsed or Resistant Hodgkin's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00388349
• Other study ID #: BMT135
• Secondary ID: 1K23AI052413-01A
• Status: Completed
• Phase: Phase 2
• First received: October 12, 2006
• Last updated: August 27, 2013
• Start date: September 2001
• Est. completion date: September 2010

Study information

• Verified date: August 2013
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: September 2010
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hodgkin Disease
• Lymphoma
• Lymphoma, Hodgkin Disease
• Lymphoma: Hodgkin

Intervention

Drug:
• Gemcitabine

• Vinorelbine

• Carmustine

• Etoposide

• Cyclophosphamide

Procedure:
• Autologous hematopoietic stem cell transplantation.

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		May 2012	No
Primary	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)		completed June 2005	Yes
Secondary	Assess the pulmonary toxicity of a novel preparatory regimen containing gemcitabine, vinorelbine, carmustine, etoposide and cyclophosphamide in a phase II study.		September 2010	Yes