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A Phase II Trial of Multiple Cycles of Sequential High Dose Chemotherapy for Patients With Chemotherapy Sensitive Relapsed Non-Hodgkin's Lymphoma

Phase 2
18 Years
Not Enrolling

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Trial Information

A Phase II Trial of Multiple Cycles of Sequential High Dose Chemotherapy for Patients With Chemotherapy Sensitive Relapsed Non-Hodgkin's Lymphoma

OBJECTIVES: I. Determine how many patients with chemotherapy sensitive relapsed
non-Hodgkin's lymphoma receiving sequential high dose chemotherapy achieve a collection of a
minimum 5 million CD34+ cells/kg in one large volume apheresis. II. Determine the
feasibility and safety of this regimen in these patients. III. Determine disease free and
overall survival of patients receiving this regimen.

OUTLINE: Patients receive cyclophosphamide IV over 1 hour followed by paclitaxel IV over 24
hours on day 1. Filgrastim (G-CSF) and stem cell factor (SCF) are administered
subcutaneously beginning on day 3 for approximately 7-14 days (until the completion of
leukapheresis). Peripheral blood stem cells (PBSC) are collected over 3-5 days. Three weeks
after leukapheresis is completed, patients receive cytarabine IV over 2 hours twice a day on
days -6 to -3. Mitoxantrone IV is administered over 1 hour on day -6. CD34+ PBSC are
reinfused on day 0. Four weeks later, patients receive etoposide IV over 11 hours on day -2
and melphalan IV over 30 minutes twice on day -1. CD34+ PBSC are reinfused on day 0.
Concurrent G-CSF is administered subcutaneously and continues until blood counts recover.
Patients are followed at 4 weeks, every 3 months for the first 2 years, and then every 6
months for the next 2 years.

PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed follicular or diffuse large cell,
diffuse mixed, or immunoblastic non-Hodgkin's lymphoma (working formulation D, F, G, or H)
First relapse from a complete response or complete response unconfirmed after a front line
chemotherapy regimen (e.g., CHOP-like regimen) Second relapse from partial response after
2-4 courses of second line standard dose chemotherapy (e.g., MINE, EPOCH, or
platinum-containing regimens) No more than 1 salvage treatment regimen No CNS involvement

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy:
Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Hepatic: Transaminases no greater than 2 times upper limit of normal
Bilirubin no greater than 2 mg/dL (unless due to biopsy proven lymphoma) No chronic viral
hepatitis Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60
mL/min No overt renal insufficiency Cardiovascular: LVEF at least 45% No congestive heart
failure (New York Heart Association class III or IV) No myocardial infarction within past
6 months No uncontrolled hypertension (diastolic blood pressure greater than 115 mmHg) No
unstable angina No coronary angioplasty within past 6 months No uncontrolled atrial or
ventricular cardiac arrhythmias Pulmonary: DLCO and FEV1 at least 45% of predicted No
severe pulmonary disease No seasonal or recurrent asthma within past 10 years No asthmatic
symptoms (e.g., wheezing) related to current respiratory tract infection No concurrent
symptoms of bronchoconstriction No anaphylactic/anaphylactoid-type event manifested by
disseminated urticaria, laryngeal edema, and/or bronchospasm Other: Not pregnant or
nursing Negative pregnancy test Fertile patients must use effective contraception HIV
negative No prior malignancy within the past 5 years except carcinoma in situ of the
cervix or basal cell or squamous cell skin cancer No severe medical or psychiatric illness
(including severe depression) No active peptic ulcer disease No poorly controlled diabetes
No allergy to insect vemons No active history of angioedema or recurrent urticaria (an
isolated episode of urticaria is allowed) No active infection No fever greater than 38.2
degrees C (except fevers due to B symptoms) No allergy to E. coli derived products

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 1 week since prior hematopoietic
growth factors Chemotherapy: See Disease Characteristics At least 4 weeks since prior
chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to
relapsed sites of vital organs (except as part of initial treatment) At least 4 weeks
since prior palliative radiotherapy to bulky nodes Surgery: At least 2 weeks since prior
major surgery Other: No other concurrent investigational drugs No concurrent beta
adrenergic blocking agents

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Russell J. Schilder, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center


United States: Federal Government

Study ID:




Start Date:

December 1998

Completion Date:

August 2001

Related Keywords:

  • Lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin



Fox Chase Cancer Center Philadelphia, Pennsylvania  19111