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Dose Finding Study of IDEC-Y2B8 With Autologous Stem Cell Support


Phase 0
18 Years
70 Years
Not Enrolling
Both
Contiguous Stage II Adult Diffuse Large Cell Lymphoma, Contiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma, Contiguous Stage II Grade 1 Follicular Lymphoma, Contiguous Stage II Grade 2 Follicular Lymphoma, Contiguous Stage II Grade 3 Follicular Lymphoma, Contiguous Stage II Mantle Cell Lymphoma, Contiguous Stage II Marginal Zone Lymphoma, Contiguous Stage II Small Lymphocytic Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma, Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma, Noncontiguous Stage II Grade 1 Follicular Lymphoma, Noncontiguous Stage II Grade 2 Follicular Lymphoma, Noncontiguous Stage II Grade 3 Follicular Lymphoma, Noncontiguous Stage II Mantle Cell Lymphoma, Noncontiguous Stage II Marginal Zone Lymphoma, Noncontiguous Stage II Small Lymphocytic Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Small Cleaved Cell Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Small Lymphocytic Lymphoma, Stage I Adult Diffuse Large Cell Lymphoma, Stage I Adult Diffuse Small Cleaved Cell Lymphoma, Stage I Grade 1 Follicular Lymphoma, Stage I Grade 2 Follicular Lymphoma, Stage I Grade 3 Follicular Lymphoma, Stage I Mantle Cell Lymphoma, Stage I Marginal Zone Lymphoma, Stage I Small Lymphocytic Lymphoma, Stage III Adult Diffuse Large Cell Lymphoma, Stage III Adult Diffuse Small Cleaved Cell Lymphoma, Stage III Grade 1 Follicular Lymphoma, Stage III Grade 2 Follicular Lymphoma, Stage III Grade 3 Follicular Lymphoma, Stage III Mantle Cell Lymphoma, Stage III Marginal Zone Lymphoma, Stage III Small Lymphocytic Lymphoma, Stage IV Adult Diffuse Large Cell Lymphoma, Stage IV Adult Diffuse Small Cleaved Cell Lymphoma, Stage IV Grade 1 Follicular Lymphoma, Stage IV Grade 2 Follicular Lymphoma, Stage IV Grade 3 Follicular Lymphoma, Stage IV Mantle Cell Lymphoma, Stage IV Marginal Zone Lymphoma, Stage IV Small Lymphocytic Lymphoma, Waldenström Macroglobulinemia

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Trial Information

Dose Finding Study of IDEC-Y2B8 With Autologous Stem Cell Support


PRIMARY OBJECTIVES:

I. To determine the maximum tolerated dose of IDEC-Y2B8 when administered with rituximab in
vivo purging and autologous stem cell rescue.

II. To obtain correlative laboratory data of in vivo purging with rituximab in patients with
0-35% marrow involvement.

OUTLINE: This is a multicenter, dose-escalation study of yttrium Y 90 ibritumomab tiuxetan
(IDEC-Y2B8).

PART I: Patients receive rituximab IV on days 1, 8, 15, and 22 and cyclophosphamide IV over
1 hour on day 25. Filgrastim (G-CSF) is administered subcutaneously (SC) daily beginning on
day 26 and continuing until autologous peripheral blood stem cells (PBSC) are harvested.

PART II: Beginning 4-6 weeks after completion of the fourth rituximab infusion, patients
receive indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1 followed by dosimetry
imaging on days 1, 2, 4, and 7. Patients then receive IDEC-Y2B8 IV over 10 minutes once
between days 8-15.

The initial 3 patients receive the same dose of IDEC-Y2B8 and then subsequent cohorts of 3-5
patients receive escalating doses of IDEC-Y2B8 until the maximum tolerated dose is
determined.

PART III: All patients undergo PBSC transplantation (PBSCT) beginning after residual bone
marrow radioactivity resolves. G-CSF is administered SC beginning 1 day after PBSCT and
continuing until blood counts recover.

Patients are followed every 3 months for 1 year and then every 6 months thereafter.


Inclusion Criteria:



- All patients must have a biopsy-proven indolent or diffuse large B-cell non-Hodgkin's
lymphoma as defined as REAL classification marginal zone/MALT, mantle cell,
plasmacytoid, lymphoplasmacytoid, small lymphocytic lymphoma or follicle center
grades I, II, III or diffuse large B-cell (CLL patients will not be eligible);
transformation from a low grade to intermediate or high grade lymphoma is also
permissible; patients with diffuse large cell lymphoma must not be eligible for any
known potentially curative therapy; at least one diagnostic pathologic specimen will
be reviewed by the JHH Pathology Department

- Patients must have received at least one but not more than five prior chemotherapy
regimens for treatment of their lymphoma

- Patients may not have received prior external beam radiation therapy to > 25% of
active bone marrow (involved field or regional)

- Patients must have 0-35% morphologically identifiable tumor in the trabecular space
on bone marrow biopsy; in patients with lymphomas in whom tumor is morphologically
difficult to distinguish from normal cells, flow cytometry must show 0-35%
identifiable tumor within 4 weeks of registration

- Patients must have =< 35% bone marrow involvement with tumor due to risk of
engraftment failure

- Patients may not have hypocellular bone marrow (=< 15% cellularity) or marked
decrease in any one (or more) hematopoietic precursor

- Patients may not have received prior murine compounds due to risk of HAMA formation

- WBC must be >= 3,000

- Total lymphocyte count must be < 5,000

- Hgb must be >= 10.0

- Platelets must be >= 75,000

- Serum creatinine must not be greater than 2.0 mg/dl

- Direct bilirubin must be =< 2mg/dl unless secondary to tumor

- AST or ALT must be < 2 x the upper limit of normal

- Normal (>= 45%) left ventricular cardiac ejection fraction, (determined by
echocardiogram or MUGA scan)

- DLCO must be > 50% predicted

- Patients with active infections requiring oral or intravenous antibiotics are not
eligible for entry onto the study until resolution of the infection

- ECOG performance status =< 2

- Not pregnant (confirmed by serum pregnancy test in females of reproductive potential)
or breast feeding, because it is unknown what effect these drugs will have on
children

- Women of childbearing potential and sexually active males are strongly advised to use
an accepted and effective method of contraception

- Patients with a second malignancy other than basal cell carcinoma or squamous cell
carcinoma of the skin or in situ carcinoma of the cervix are not eligible unless the
tumor was treated with curative intent at least two years previously

- Women and minorities are encouraged to participate

- Patients who have received prior anti-CD20 therapy must have achieved a partial or
complete response

- Patients who are HIV positive will be excluded due to increased risk for bone marrow
suppression and other toxicities

- Patients who have received prior radioimmunotherapy, for example Zevalin or Bexxar,
are not eligible

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

MTD, defined in terms of clinical toxicities graded using the CTC version 2.0

Outcome Description:

The modified continual reassessment method (CRM) will be employed to estimate the MTD.

Outcome Time Frame:

Up to day 15

Safety Issue:

Yes

Principal Investigator

Lode Swinnen

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins University

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-03156

NCT ID:

NCT00017381

Start Date:

April 2001

Completion Date:

Related Keywords:

  • Contiguous Stage II Adult Diffuse Large Cell Lymphoma
  • Contiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma
  • Contiguous Stage II Grade 1 Follicular Lymphoma
  • Contiguous Stage II Grade 2 Follicular Lymphoma
  • Contiguous Stage II Grade 3 Follicular Lymphoma
  • Contiguous Stage II Mantle Cell Lymphoma
  • Contiguous Stage II Marginal Zone Lymphoma
  • Contiguous Stage II Small Lymphocytic Lymphoma
  • Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
  • Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma
  • Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma
  • Noncontiguous Stage II Grade 1 Follicular Lymphoma
  • Noncontiguous Stage II Grade 2 Follicular Lymphoma
  • Noncontiguous Stage II Grade 3 Follicular Lymphoma
  • Noncontiguous Stage II Mantle Cell Lymphoma
  • Noncontiguous Stage II Marginal Zone Lymphoma
  • Noncontiguous Stage II Small Lymphocytic Lymphoma
  • Recurrent Adult Diffuse Large Cell Lymphoma
  • Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
  • Recurrent Grade 1 Follicular Lymphoma
  • Recurrent Grade 2 Follicular Lymphoma
  • Recurrent Grade 3 Follicular Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Recurrent Marginal Zone Lymphoma
  • Recurrent Small Lymphocytic Lymphoma
  • Stage I Adult Diffuse Large Cell Lymphoma
  • Stage I Adult Diffuse Small Cleaved Cell Lymphoma
  • Stage I Grade 1 Follicular Lymphoma
  • Stage I Grade 2 Follicular Lymphoma
  • Stage I Grade 3 Follicular Lymphoma
  • Stage I Mantle Cell Lymphoma
  • Stage I Marginal Zone Lymphoma
  • Stage I Small Lymphocytic Lymphoma
  • Stage III Adult Diffuse Large Cell Lymphoma
  • Stage III Adult Diffuse Small Cleaved Cell Lymphoma
  • Stage III Grade 1 Follicular Lymphoma
  • Stage III Grade 2 Follicular Lymphoma
  • Stage III Grade 3 Follicular Lymphoma
  • Stage III Mantle Cell Lymphoma
  • Stage III Marginal Zone Lymphoma
  • Stage III Small Lymphocytic Lymphoma
  • Stage IV Adult Diffuse Large Cell Lymphoma
  • Stage IV Adult Diffuse Small Cleaved Cell Lymphoma
  • Stage IV Grade 1 Follicular Lymphoma
  • Stage IV Grade 2 Follicular Lymphoma
  • Stage IV Grade 3 Follicular Lymphoma
  • Stage IV Mantle Cell Lymphoma
  • Stage IV Marginal Zone Lymphoma
  • Stage IV Small Lymphocytic Lymphoma
  • Waldenström Macroglobulinemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Waldenstrom Macroglobulinemia
  • Lymphoma, B-Cell
  • Lymphoma, B-Cell, Marginal Zone
  • Lymphoma, Mantle-Cell

Name

Location

Johns Hopkins UniversityBaltimore, Maryland  21205