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

NCT ID: NCT00388349

Last Updated: 2017-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-09-30
• Study Completion Date: 2010-09-30

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

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)].

Conditions

Hodgkin Disease; Hodgkin's Lymphoma; Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gemcitabine + Autologous HCT

Gemcitabine and high-dose chemotherapy followed by peripheral blood stem cell (PBSC) rescue. Chemotherapy includes Gemcitabine + Vinorelbine + Carmustine + Etoposide + Cyclophosphamide.

Group Type: EXPERIMENTAL

Gemcitabine

Intervention Type: DRUG

Vinorelbine

Intervention Type: DRUG

Carmustine

Intervention Type: DRUG

Etoposide

Intervention Type: DRUG

Cyclophosphamide

Intervention Type: DRUG

Autologous HCT

Intervention Type: PROCEDURE

Interventions

Gemcitabine

Intervention Type: DRUG

Vinorelbine

Intervention Type: DRUG

Carmustine

Intervention Type: DRUG

Etoposide

Intervention Type: DRUG

Cyclophosphamide

Intervention Type: DRUG

Autologous HCT

Intervention Type: PROCEDURE

Other Intervention Names

Gemzar; Navelbine; BCNU; Vepesid; Cytoxan; Neosar; Peripheral blood stem cell (PBSC) rescue

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Sally Arai

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sally Arai, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

References

Arai S, Letsinger R, Wong RM, Johnston LJ, Laport GG, Lowsky R, Miklos DB, Shizuru JA, Weng WK, Lavori PW, Blume KG, Negrin RS, Horning SJ. Phase I/II trial of GN-BVC, a gemcitabine and vinorelbine-containing conditioning regimen for autologous hematopoietic cell transplantation in recurrent and refractory hodgkin lymphoma. Biol Blood Marrow Transplant. 2010 Aug;16(8):1145-54. doi: 10.1016/j.bbmt.2010.02.022. Epub 2010 Mar 1.

Reference Type: BACKGROUND

PMID: 20197102 (View on PubMed)

Other Identifiers

1K23AI052413-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

BMT135

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-13511

Identifier Type: -

Identifier Source: org_study_id