Phase 2
N=7
Gemcitabine and Hodgkin's Disease Chemotherapy Followed by Peripheral Blood Stem Cell Rescue for Hodgkin's Disease
Hodgkin Disease · Hodgkin's Lymphoma · Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00388349 ↗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
| Outcome | Result | p-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.
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.