A Phase II Trial of ICE Chemotherapy Followed by High Dose BEAM Chemotherapy With Autologous Peripheral Blood Progenitor Cell Transplantation in Patients >= 60 Years Old With Refractory or Relapsed Intermediate Grade Non-Hodgkin's Lymphoma
60 Years
N/A
Both
Lymphoma
Trial Information
A Phase II Trial of ICE Chemotherapy Followed by High Dose BEAM Chemotherapy With Autologous Peripheral Blood Progenitor Cell Transplantation in Patients >= 60 Years Old With Refractory or Relapsed Intermediate Grade Non-Hodgkin's Lymphoma
OBJECTIVES:
- Assess the efficacy and toxic effects of carmustine/etoposide/melphalan (ICE)
chemotherapy followed by peripheral blood progenitor cell transplantation in patients
with refractory or relapsed intermediate grade non-Hodgkin's lymphoma.
- Assess the ability of the ICE chemotherapy regimen, in conjunction with filgrastim, to
mobilize peripheral blood stem cells.
OUTLINE: This is a descriptive pilot study.
Patients receive 3 cycles of induction chemotherapy with ifosfamide, carboplatin, and
etoposide (ICE). Each cycle is given at least 14 days apart. Patients receive etoposide IV
on days 1 through 3. Carboplatin and ifosfamide with mercaptoethane sulfonate is given IV
over 24 hours on day 2.
During cycles 1 and 2, patients receive filgrastim (G-CSF) SC every 6 hours beginning on day
1 and continuing until the desired absolute neutrophil count (ANC) is attained.
Patients receive at least 24 hours of rest before PBPC infusion on day 0.
Following cycle 3, G-CSF is given SC beginning on day 6 and continuing until completion of
PBPC collection. However, bone marrow will be harvested if an insufficient number of stem
cells are collected after 5 leukaphereses.
Patients with residual disease limited to 2 sites receive radiation therapy twice a day
within 2 weeks prior to high dose BEAM chemotherapy with carmustine, etoposide, cytarabine,
and melphalan.
Patients receive carmustine IV on day -7. Etoposide and cytarabine are given IV every 12
hours on days -6 through -3. Melphalan is given IV on day -2.
G-CSF is administered every 12 hours beginning on day 1 and continuing until the desired ANC
is attained. If ANC is attenuated on day 21, patients undergo a repeat bone marrow biopsy
and receive filgrastim SC.
Patients are followed for 2 years posttransplant, then for 3 to 5 years at 4 month intervals
and every 6 months following the fifth posttransplant.
PROJECTED ACCRUAL: This study will accrue 30 patients for the duration of 2 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Primary refractory intermediate grade non-Hodgkin's lymphoma (NHL) OR
- Untreated relapsed intermediate grade NHL with no more than 1 extranodal site of
disease
- Biopsy proven relapse of diffuse large cell, diffuse mixed cell, diffuse small
cleaved cell (excluding mantle cell lymphoma), follicular large cell, anaplastic
large cell or immunoblastic NHL in recently attained complete response patients
PATIENT CHARACTERISTICS:
Age:
- 60 and over
Performance status:
- Karnofsky at least 80%
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Bilirubin no greater than 2.0 mg/dL unless there is a history of Gilbert's disease
Renal:
- No history of chronic renal insufficiency
- Creatinine no greater than 1.5 mg/dL or if greater than 1.5 mg/dL, then creatinine
clearance must be at least 60 mL/min
Cardiovascular:
- No myocardial infarction within the past 6 months
- No unstable angina or cardiac arrhythmias other than chronic atrial fibrillation
- Normal cardiac function required; MUGA scan or stress ECG ejection fraction at least
50% without significant wall motion abnormalities
Pulmonary:
- Adequate pulmonary function defined as DLCO at least 50% of predicted value when
corrected for patients hemoglobin and alveolar ventilation
Other:
- No medical illness unrelated to intermediate grade Non-Hodgkin's Lymphoma
- No uncontrolled infection
- No history of malignancy other than curatively treated cutaneous basal cell
carcinoma; carcinoma in situ of the cervix; axillary node negative breast cancer
without prior chemotherapy and disease free for more than 2 years; or prostate cancer
with surgery alone and disease free for more than 2 years
- No lymphoblastic lymphoma, small noncleaved cell lymphoma, CNS lymphoma or CNS
relapse of lymphoma
- Not HIV, HBV, and HCV positive
PRIOR CONCURRENT THERAPY:
- Concurrent enrollment in MSKCC protocol 96-17a allowed
Biologic therapy:
- Not specified
Chemotherapy:
- No more than 2 prior chemotherapy regimens
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Outcome Measure:
Treatment-related toxicity
Safety Issue:
Yes
Principal Investigator
Craig Moskowitz, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000065505
NCT ID:
NCT00002982
Start Date:
January 1997
Completion Date:
Related Keywords:
- Lymphoma
- recurrent grade 3 follicular lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult immunoblastic large cell lymphoma
- anaplastic large cell lymphoma
- Lymphoma
- Lymphoma, Non-Hodgkin
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
