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HIGH-DOSE CHEMORADIOTHERAPY FOLLOWED BY RESCUE WITH MOBILIZED AUTOLOGOUS PERIPHERAL BLOOD STEM CELLS IN PATIENTS WITH LOW-GRADE, TRANSFORMED, OR FOLLICULAR LARGE CELL NON-HODGKIN'S LYMPHOMA


Phase 1/Phase 2
16 Years
65 Years
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

HIGH-DOSE CHEMORADIOTHERAPY FOLLOWED BY RESCUE WITH MOBILIZED AUTOLOGOUS PERIPHERAL BLOOD STEM CELLS IN PATIENTS WITH LOW-GRADE, TRANSFORMED, OR FOLLICULAR LARGE CELL NON-HODGKIN'S LYMPHOMA


OBJECTIVES: I. Evaluate the overall and progression-free survival of patients with selected
poor-prognosis non-Hodgkin's lymphomas treated with high-dose etoposide and total-body
irradiation followed by rescue with peripheral blood stem cells. II. Determine the toxicity
of this regimen. III. Evaluate the short-term and long-term engraftment characteristics of
patients treated on this regimen.

OUTLINE: Patients who respond on Regimen A and who have no bulk disease greater than 5 cm
are treated on Regimen B. Regimen A: Single-Agent Chemotherapy/Stem Cell Mobilization with
Urothelial Protection and Growth Factor Therapy. Cyclophosphamide, CTX, NSC-26271; with
Mesna, NSC-113891; and Granulocyte Colony Stimulating Factor (Amgen), G-CSF, NSC-614629.
Regimen B: Sequential Radiotherapy, Single-Agent Chemotherapy, and Stem Cell Rescue.
Total-body irradiation, TBI (equipment not specified); Etoposide, VP-16, NSC-141540; and
Peripheral Blood Stem Cells, PBSC.

PROJECTED ACCRUAL: 20 patients will be studied.

Inclusion Criteria


DISEASE CHARACTERISTICS: Pathologically confirmed non-Hodgkin's lymphomas of the following
histologic subtypes: Small lymphocytic Follicular small cleaved cell Follicular mixed cell
Follicular large cell (relapsed) Disease in first, second, or third partial remission (25%
shrinkage in cross-sectional area of measurable disease) or first, second, or subsequent
relapse required Transformed non-Hodgkin's lymphoma eligible, i.e., low-grade lymphoma
subsequently transformed to intermediate- or high-grade lymphoma No lymphosarcoma cell
leukemia

PATIENT CHARACTERISTICS: Age: 16 to 65 Performance status: Karnofsky 80-100%
Hematopoietic: WBC at least 5,000/mm3 (polys at least 2,000/mm3) Platelet count at least
100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT no greater than 2 times
normal Renal: Creatinine no greater than 1.8 mg/dL Cardiovascular: LVEF at least 50%
Pulmonary: FVC greater than 1.5 liters FEV1 greater than 1.2 liters MVV greater than 50
liters DLCO greater than 12 mL/min pO2 greater than 70 mm Hg on room air Other: No other
serious psychiatric, neurologic, or medical illness

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified
Endocrine therapy: Not specified Radiotherapy: Less than 3,500 cGy prior irradiation to
the mediastinum, lungs, or spinal cord Surgery: Not specified

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Thomas R. Klumpp, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000078066

NCT ID:

NCT00002510

Start Date:

April 1992

Completion Date:

June 2001

Related Keywords:

  • Lymphoma
  • Waldenstrom macroglobulinemia
  • recurrent small lymphocytic lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Temple University Cancer CenterPhiladelphia, Pennsylvania  19140