Know Cancer

or
forgot password

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


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Lymphoma, Hodgkin Disease, Lymphoma, Hodgkin Disease, Lymphoma: Hodgkin

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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.

Outcome Time Frame:

May 2012

Safety Issue:

No

Principal Investigator

Sally Arai

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Institutional Review Board

Study ID:

BMT135

NCT ID:

NCT00388349

Start Date:

September 2001

Completion Date:

May 2012

Related Keywords:

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

Name

Location

Stanford University School of MedicineStanford, California  94305-5317