Radiolabeled Monoclonal Antibody Therapy and High-Dose Chemotherapy Followed By Autologous Peripheral Stem Cell Transplant in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT00058292
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
17 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • filgrastim — BIOLOGICAL
    Given at a dose of 5 μg/kg, subcutaneously daily, beginning on Day 0 (stem cell transplant day) until white blood cells measure greater than 1500/ul.
  • rituximab — BIOLOGICAL
    Intravenous infusion of 250 mg/m2 on treatment days -22 and -14 (day 0 = stem cell transplant).
  • Carmustine — DRUG
    Part of high dose BEAM chemotherapy given on study (a combination of carmustine, etoposide, cytarabine, and melphalan). Carmustine is given at a dose of 300 mg/m2 intravenous infusion over a 2 hour period on treatment day -6 (Day 0 = stem cell transplant).
  • cytarabine — DRUG
    Part of high dose BEAM chemotherapy given on study (a combination of carmustine, etoposide, cytarabine, and melphalan). Cytarabine is given at a dose of 100 mg/m2 intravenous infusion over a 1 hour period, every 12 hours on treatment days -5, -4, -3, and -2, for a total of 8 doses (Day 0 = stem cell transplant).
  • etoposide — DRUG
    Part of high dose BEAM chemotherapy given on study (a combination of carmustine, etoposide, cytarabine, and melphalan). Etoposide is given at a dose of 100 mg/m2 intravenous infusion over a 2 hour period every 12 hours on treatment days -5, -4, -3, and -2, for a total of 8 doses (Day 0 = stem cell transplant).
  • melphalan — DRUG
    Part of high dose BEAM chemotherapy given on study (a combination of carmustine, etoposide, cytarabine, and melphalan). Melphalan is given at a dose of 140 mg/m2 as an intravenous infusion over a 1 hour period on treatment day -1 (Day 0 = stem cell transplant).
  • peripheral blood stem cell transplantation — PROCEDURE
    On day 0, a minimum of 2.0 X 106 CD34+ cells/kg unselected peripheral blood progenitor cells (PBPC) will be reinfused following institutional guidelines for the reinfusion procedure.
  • yttrium Y 90 ibritumomab tiuxetan — RADIATION
    Patients will receive 90Y2B8 at a variable dose on treatment day -14 (Day 0 = stell cell transplant). The initial dose calculated to deliver no more than 100 cGy to critical organs (liver, lung). Doses will be escalated based on cohort of enrollment.

Study Details

RATIONALE: Radiolabeled monoclonal antibodies such as yttrium Y90 ibritumomab tiuxetan can locate cancer cells and deliver radioactive cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining yttrium Y90 ibritumomab tiuxetan and chemotherapy with autologous stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: This phase I trial is studying how well giving yttrium Y90 ibritumomab tiuxetan with high-dose chemotherapy followed by autologous stem cell transplant work in treating patients with relapsed or refractory non-Hodgkin's lymphoma.

Key Dates

Start date
Apr 30, 2000
Status verified
May 2012
Primary completion
Jun 30, 2006
Completion
Mar 31, 2009

Study Design

Enrollment
44 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm

Primary Outcome Measure

Determine the maximum tolerated dose of absorbed radiation to critical organs delivered with this combination of study treatments [ Time Frame: From first study treatment until 30 days after last study treatment. ]

Locations (3)

FacilityCityStateZIPSite coordinators
Hematology-Oncology Associates of IllinoisChicagoIllinois60611-2998-
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicagoIllinois60611-3013-
Mayo Clinic Cancer CenterRochesterMinnesota55905-

Find similar trials in Chicago, IL

By research site
Hematology-Oncology Associates of Illinois· Chicago, ILRobert H. Lurie Comprehensive Cancer Center at Northwestern University· Chicago, ILMayo Clinic Cancer Center· Rochester, MN

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