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

NCT00388349 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: IRB-135111K23AI052413-01A1BMT135
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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

Conditions

Hodgkin Disease; Hodgkin's Lymphoma; Lymphoma

Outcome Measures

Primary Outcomes (1)

• Dose-limiting Toxicity of Gemcitabine Due to Non-hematologic Toxicity

  Reported as the number of Phase 1 participants by gemcitabine dose that experienced non-hematologic toxicity, ie, drug-related adverse events.

  6 months

Secondary Outcomes (4)

• Pulmonary Toxicity (BCNU Pneumonitis)

  2 years

• Overall Survival (OS)

  2 years

• Relapse Post-transplant

  2 years

• Survival Measures

  2 years

Study Arms (1)

Gemcitabine + Autologous HCT

EXPERIMENTAL

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

Drug: Gemcitabine; Drug: Vinorelbine; Drug: Carmustine; Drug: Etoposide; Drug: Cyclophosphamide; Procedure: Autologous HCT

Interventions

Gemcitabine DRUG

Also known as: Gemzar

Gemcitabine + Autologous HCT

Vinorelbine DRUG

Also known as: Navelbine

Gemcitabine + Autologous HCT

Carmustine DRUG

Also known as: BCNU

Gemcitabine + Autologous HCT

Etoposide DRUG

Also known as: Vepesid

Gemcitabine + Autologous HCT

Cyclophosphamide DRUG

Also known as: Cytoxan, Neosar

Gemcitabine + Autologous HCT

Autologous HCT PROCEDURE

Also known as: Peripheral blood stem cell (PBSC) rescue

Gemcitabine + Autologous HCT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

• 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.

  PMID: 20197102 BACKGROUND

MeSH Terms

Conditions

Hodgkin Disease; Lymphoma

Interventions

Gemcitabine; Vinorelbine; Carmustine; Etoposide; Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Results Point of Contact

• Title: Dr. Sally Arai
• Organization: Stanford University

sarai1@stanford.edu

650-723-0822

Study Officials

• Sally Arai, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: October 12, 2006
• First Posted: October 16, 2006
• Study Start: September 1, 2001
• Primary Completion: March 1, 2008
• Study Completion: September 1, 2010
• Last Updated: June 14, 2017
• Results First Posted: June 14, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)