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In Vivo Imaging of Effector Cells in Anti-Lymphoma Therapy


N/A
18 Years
N/A
Open (Enrolling)
Both
Lymphoma, Small Intestine Cancer

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Trial Information

In Vivo Imaging of Effector Cells in Anti-Lymphoma Therapy


OBJECTIVES:

- Determine the number of indium In 111-labeled peripheral blood mononuclear cells
(PBMCs) and indium In 111-labeled polymorphonuclear leukocytes (PMNLs) trafficking into
lymphoma tumors prior to therapy in patients with non-Hodgkin's lymphoma.

- Compare the number of PBMC and PMNL trafficking prior to vs after therapy in these
patients.

- Compare, preliminarily, the number of in vivo baseline (i.e., pre-therapy) trafficking
of PBMCs vs PMNLs in these patients.

- Gather important data regarding the inter- and intra-patient variability of effector
cell trafficking into these tumors.

- Assess the relationship between response at 8-12 weeks and the magnitude of baseline
effector cell trafficking or the magnitude of post-rituximab effector cell trafficking
in these patients.

OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 groups.

- Group I: Patients receive autologous indium In 111 (^111In)-labeled peripheral blood
mononuclear cells on day 0.

- Group II: Patients receive autologous ^111In-labeled polymorphonuclear leukocytes on
day 0.

In both groups, patients undergo blood collection on day 0. Patients then undergo full-body
single-photon emission-computed tomography (SPECT) scan 4 hours after cell infusion and on
day 2. The labeling and imaging process may be repeated after at least 1 course of
anticancer treatment.

Cellular uptake is measured by reader/visual interpretation, a semiquantitative grading
system, and tumor-to-background uptake ratios.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed non-Hodgkin's lymphoma

- Indolent or aggressive disease

- Planning to receive a new regimen or starting a regimen of cancer therapy

- At least one tumor lesion measurable in two dimensions as ≥ 1.5 cm by CT scan

PATIENT CHARACTERISTICS:

- ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%

- Life expectancy ≥ 3 months

- No concurrent medical complications that would preclude study compliance

- Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

- At least 3 weeks since prior chemotherapy (except for nonmyelosuppressive treatments)

- At least 3 weeks since prior radiation therapy

- Concurrent rituximab allowed

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Number of baseline indium In 111-labeled peripheral blood mononuclear cells (PBMCs) trafficking into tumors

Safety Issue:

No

Principal Investigator

Gregory Wiseman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

Unspecified

Study ID:

CDR0000529768

NCT ID:

NCT00897923

Start Date:

September 2003

Completion Date:

Related Keywords:

  • Lymphoma
  • Small Intestine Cancer
  • AIDS-related peripheral/systemic lymphoma
  • AIDS-related primary CNS lymphoma
  • anaplastic large cell lymphoma
  • angioimmunoblastic T-cell lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • intraocular lymphoma
  • nodal marginal zone B-cell lymphoma
  • primary central nervous system non-Hodgkin lymphoma
  • recurrent adult Burkitt lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent adult T-cell leukemia/lymphoma
  • recurrent cutaneous T-cell non-Hodgkin 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 mycosis fungoides/Sezary syndrome
  • recurrent small lymphocytic lymphoma
  • small intestine lymphoma
  • splenic marginal zone lymphoma
  • stage III adult Burkitt lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage III adult diffuse small cleaved cell lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage III adult T-cell leukemia/lymphoma
  • stage III cutaneous T-cell non-Hodgkin 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 mycosis fungoides/Sezary syndrome
  • stage III small lymphocytic lymphoma
  • stage IV adult Burkitt lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage IV adult T-cell leukemia/lymphoma
  • stage IV cutaneous T-cell non-Hodgkin 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 mycosis fungoides/Sezary syndrome
  • stage IV small lymphocytic lymphoma
  • Waldenström macroglobulinemia
  • stage I adult Burkitt lymphoma
  • stage I adult diffuse large cell lymphoma
  • stage I adult diffuse mixed cell lymphoma
  • stage I adult diffuse small cleaved cell lymphoma
  • stage I adult immunoblastic large cell lymphoma
  • stage I adult lymphoblastic lymphoma
  • stage I adult T-cell leukemia/lymphoma
  • stage I cutaneous T-cell non-Hodgkin 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 II adult T-cell leukemia/lymphoma
  • adult grade III lymphomatoid granulomatosis
  • adult nasal type extranodal NK/T-cell lymphoma
  • recurrent adult grade III lymphomatoid granulomatosis
  • contiguous stage II adult Burkitt lymphoma
  • contiguous stage II adult diffuse large cell lymphoma
  • contiguous stage II adult diffuse mixed cell lymphoma
  • contiguous stage II adult diffuse small cleaved cell lymphoma
  • contiguous stage II adult immunoblastic large cell lymphoma
  • contiguous stage II adult lymphoblastic 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
  • noncontiguous stage II adult Burkitt lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult diffuse mixed cell lymphoma
  • noncontiguous stage II adult diffuse small cleaved cell lymphoma
  • noncontiguous stage II adult immunoblastic large cell lymphoma
  • noncontiguous stage II adult lymphoblastic 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
  • stage I mycosis fungoides/Sezary syndrome
  • stage II mycosis fungoides/Sezary syndrome
  • stage II cutaneous T-cell non-Hodgkin lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large-Cell, Immunoblastic
  • Duodenal Neoplasms
  • Ileal Neoplasms
  • Jejunal Neoplasms
  • Intestinal Neoplasms

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002