Phase II Study of Intensive Carmustine and Etoposide With Cisplatin or Cyclophosphamide, Followed By Rescue With Autologous Bone Marrow Treated In Vitro With Etoposide and/or Peripheral Blood Stem Cells Mobilized With Filgrastim (G-CSF) or Sargramostim (GM-CSF) With or Without Radiotherapy in Patients With Resistant Hodgkin's Disease or Non-Hodgkin's Lymphoma
OBJECTIVES: I. Determine the antitumor activity of intensive carmustine and etoposide with
cisplatin or cyclophosphamide, followed by rescue with autologous bone marrow (ABM) treated
in vitro with etoposide and/or peripheral blood stem cells mobilized with filgrastim (G-CSF)
or sargramostim (GM-CSF) with or without radiotherapy in patients with refractory Hodgkin's
disease or non-Hodgkin's lymphoma. II. Determine the time to recovery of peripheral blood
counts in patients treated with this regimen. III. Correlate the rate of peripheral blood
cell recovery in these patients with in vitro growth of ABM treated with etoposide.
OUTLINE: This is a multicenter study. Autologous bone marrow (ABM) is harvested and
two-thirds of the ABM is treated in vitro with etoposide (VP-16). ABM may have been stored
earlier in the course of the disease for patients who are at high risk of relapse or who
were previously treated with agents causing bone marrow or stem cell damage (e.g.,
nitrosoureas, pelvic irradiation). Patients with prior bone marrow involvement and
subsequent bone marrow remission must have received 1 or 2 additional courses of the same
chemotherapy before undergoing harvest of ABM. Patients for whom PBSC rescue alone is
planned also undergo ABM harvest in case back-up ABM rescue is needed. Patients then receive
sargramostim (GM-CSF) or filgrastim (G-CSF) subcutaneously beginning 5 days before harvest
of peripheral blood stem cells (PBSC) and continuing until completion of harvest. Patients
without extensive prior radiotherapy undergo radiotherapy to areas of measurable active
disease plus a 2 cm margin on days -21 to -17 and -14 to -8. Patients without a
contraindication to cisplatin (e.g., hearing impairment, peripheral neuropathy) receive
cisplatin IV over 3 hours on days -7 to -3 and carmustine IV over 2 hours and VP-16 IV over
4 hours on days -6 to -4. Patients with a contraindication to cisplatin receive
cyclophosphamide IV every 12 hours, VP-16 IV over 1 hour every 12 hours, and carmustine IV
over 1 hour on days -7 to -4. ABM and/or PBSC are reinfused on day 0. The first 6 ABM rescue
patients receive untreated ABM and subsequent patients receive ABM treated in vitro with
VP-16. Patients with bone marrow biopsy showing no evidence of regeneration (marrow
cellularity less than 1%) at day 21 after PBSC rescue undergo back-up ABM rescue. Patients
without engraftment (granulocyte count less than 500/mm3 and untransfused platelets no
greater than 20,000/mm3) by day 28 after rescue with ABM treated in vitro with VP-16 undergo
rescue with untreated ABM.
PROJECTED ACCRUAL: A total of 21-46 patients will be accrued for this study.
Interventional
Primary Purpose: Treatment
Rasim Ahmet Gucalp, MD
Study Chair
Albert Einstein College of Medicine of Yeshiva University
United States: Federal Government
CDR0000075725
NCT00002461
April 1988
Name | Location |
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Albert Einstein Comprehensive Cancer Center | Bronx, New York 10461 |