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Phase 2 N=7 Treatment

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

Hodgkin Disease · Hodgkin's Lymphoma · Lymphoma

Enrolled (actual)
7
Serious AEs
21.2%
Results posted
Jun 2017
Primary outcome: Primary: Dose-limiting Toxicity of Gemcitabine Due to Non-hematologic Toxicity — 0; 3 participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Gemcitabine (Drug); Vinorelbine (Drug); Carmustine (Drug); Etoposide (Drug); Cyclophosphamide (Drug); Autologous HCT (Procedure)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Stanford University
Primary completion
Mar 2008

Outcome Measures

OutcomeResultp-value
PRIMARY
Dose-limiting Toxicity of Gemcitabine Due to Non-hematologic Toxicity
0; 3
SECONDARY
Pulmonary Toxicity (BCNU Pneumonitis)
26
SECONDARY
Overall Survival (OS)
87
SECONDARY
Relapse Post-transplant
29
SECONDARY
Survival Measures
71; 67; 83

Summary

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

Eligibility Criteria

Inclusion Criteria

  • Histologically-proven recurrent or refractory Hodgkin's Disease (Hodgkin's lymphoma) on the basis of excisional biopsy whenever possible.
  • Age 75% reduction in a bulky tumor mass and bone marrow involvement 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00388349). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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