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

Stanford University

Status and phase: Completed; Phase 2

Conditions: Hodgkin's Lymphoma; Hodgkin Disease; Lymphoma

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00388349

1K23AI052413-01A1 (U.S. NIH Grant/Contract)

IRB-13511

BMT135 (Other Identifier)

Details and patient eligibility

About

This is a phase 2 study of gemcitabine + high-dose chemotherapy followed by peripheral blood stem cell (PBSC) rescue for Hodgkin's Disease

Full 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)].

Enrollment: 146 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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146 participants in 1 patient group

Gemcitabine + Autologous HCT

Experimental group

Description:

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

Treatment:

Drug: Cyclophosphamide

Procedure: Autologous HCT

Drug: Etoposide

Drug: Carmustine

Drug: Vinorelbine

Drug: Gemcitabine