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Dose Escalation of VP-16 With Cyclophosphamide and Total Body Irradiation as Preparative Regimen for Autologous Transplantation for High-Grade Lymphoma and Acute Lymphoblastic Leukemia


Phase 1/Phase 2
N/A
65 Years
Not Enrolling
Both
Leukemia, Lymphoma

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Trial Information

Dose Escalation of VP-16 With Cyclophosphamide and Total Body Irradiation as Preparative Regimen for Autologous Transplantation for High-Grade Lymphoma and Acute Lymphoblastic Leukemia


OBJECTIVES: I. Determine the toxicity of an intensive induction regimen comprised of
etoposide with cyclophosphamide and total body irradiation (TBI) in patients with high grade
lymphoma or acute lymphoblastic leukemia (ALL). II. Determine the maximum tolerated dose of
etoposide when combined with cyclophosphamide and TBI in these patients. III. Determine the
response rate in patients treated with this induction regimen. IV. Determine the potential
for long term survival in patients with relapsed lymphoblastic lymphoma and chemotherapy
responsiveness treated with this induction regimen. V. Determine the efficacy of this
induction regimen followed by autologous peripheral blood stem cell transplantation (APBSCT)
in patients with ALL in any complete remission. VI. Determine the efficacy of this induction
regimen followed by APBSCT in patients will ALL after relapse and remission reinduction.

OUTLINE: This is a dose escalation study of etoposide. Patients undergo total body
irradiation twice daily on days -8 to -5. Patients receive etoposide IV over 30 hours
beginning on day -5 and cyclophosphamide IV over 1 hour on day -3 (beginning 6 hours after
completion of etoposide infusion) and day -2. Peripheral blood stem cells are reinfused on
day 0. Patients receive filgrastim (G-CSF) subcutaneously daily beginning on day 0 and
continuing until blood counts have recovered for 2 days. Cohorts of 5 patients receive
escalating doses of etoposide until the maximum tolerated dose (MTD) is determined. The MTD
is defined as the dose preceding that at which 3 of 5 patients experience dose limiting
toxicity. Patients are followed every month for 1 year and then every 6 months for 2.5
years.

PROJECTED ACCRUAL: A minimum of 5 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven high grade lymphoma (including small
noncleaved) by lymph node biopsy OR acute lymphoblastic leukemia (ALL) by bone marrow
aspiration and biopsy Lymphoblastic lymphoma: First remission allowed if elevated LDH or
stage IV disease Early relapse allowed Must have CT of abdomen, pelvis, and chest obtained
within 4-6 weeks prior to enrollment Measurable disease not required First remission
transplantation is encouraged if poor prognostic indicators were present at diagnosis and
the objective parameter of measure is long term disease free survival ALL: Patients with
inaspirable bone marrow aspirate smears eligible if diagnosis confirmed by bone marrow
core biopsy Any complete remission allowed All patients in relapse should have attempted
reinduction of remission Patients in early relapse (defined as no greater than 20%
lymphoblasts in bone marrow) eligible if bone marrow harvested while in remission (less
than 5% blasts) Must be eligible for total body irradiation Negative CSF cytology within
4-6 weeks of enrollment No active CNS lymphoma or leukemia A new classification scheme for
adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or
"aggressive" lymphoma will replace the former terminology of "low", "intermediate", or
"high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS: Age: Physiologic age 65 and under for autologous peripheral blood
stem cell transplantation If age 55 and under, priority should be given to finding an
allogeneic donor Performance status: ECOG 0 or 1 Life expectancy: Not specified
Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater than 2.0 mg/dL
SGOT or SGPT less than 2 times normal Renal: Creatinine less than 2.0 mg/dL
Cardiovascular: Cardiac ejection fraction at least 40% by MUGA scan or clearance by a
cardiologist No myocardial infarction within the past 6 months No active angina pectoris
Pulmonary: FEV1 and DLCO at least 50% predicted Other: No active serious psychiatric or
medical illness that would preclude administration of high dose chemotherapy HIV negative
Not pregnant Negative pregnancy test

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics
No prior radiotherapy greater than 25 Gy to the craniospinal axis Surgery: See Disease
Characteristics

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Ann Traynor, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Federal Government

Study ID:

NU 91H5T

NCT ID:

NCT00004898

Start Date:

October 1999

Completion Date:

July 2003

Related Keywords:

  • Leukemia
  • Lymphoma
  • recurrent childhood acute lymphoblastic leukemia
  • stage I childhood lymphoblastic lymphoma
  • stage II childhood lymphoblastic lymphoma
  • stage III childhood lymphoblastic lymphoma
  • stage IV childhood lymphoblastic lymphoma
  • recurrent childhood lymphoblastic lymphoma
  • recurrent adult acute lymphoblastic leukemia
  • adult acute lymphoblastic leukemia in remission
  • childhood acute lymphoblastic leukemia in remission
  • stage I adult immunoblastic large cell lymphoma
  • stage I adult lymphoblastic lymphoma
  • stage I adult Burkitt lymphoma
  • stage II adult immunoblastic large cell lymphoma
  • stage II adult lymphoblastic lymphoma
  • stage II adult Burkitt lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage III adult Burkitt lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage IV adult Burkitt lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent adult Burkitt lymphoma
  • stage I childhood small noncleaved cell lymphoma
  • stage I childhood large cell lymphoma
  • stage II childhood small noncleaved cell lymphoma
  • stage II childhood large cell lymphoma
  • stage III childhood small noncleaved cell lymphoma
  • stage III childhood large cell lymphoma
  • stage IV childhood small noncleaved cell lymphoma
  • stage IV childhood large cell lymphoma
  • recurrent childhood small noncleaved cell lymphoma
  • recurrent childhood large cell lymphoma
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large-Cell, Immunoblastic

Name

Location

Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611