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AIDS-related Peripheral/Systemic LymphomaPhase 1NCT00036855

Radiolabeled Monoclonal Antibody With or Without Peripheral Stem Cell Transplantation in Treating Children With Recurrent or Refractory Lymphoma

A Phase 1 study testing rituximab, indium In 111 ibritumomab tiuxetan and yttrium Y 90 ibritumomab tiuxetan in people with AIDS-related Peripheral/Systemic Lymphoma and AIDS-related Primary CNS Lymphoma, run by National Cancer Institute (NCI) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy with or without peripheral stem cell transplantation in treating patients who have recurrent or refractory lymphoma. Read more about this study

Who is it for?
Ages Up to 21 years
What is being tested?
rituximab, indium In 111 ibritumomab tiuxetan and yttrium Y 90 ibritumomab tiuxetan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteUnited States
Study dates
Jun 2002to Mar 2005
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Histologically confirmed and immunophenotypically (CD20)-positive lymphoma at original diagnosis, progression, or relapse
  • Refractory to conventional therapy
  • First recurrent/refractory CD20-positive non-Hodgkin's lymphoma (NHL) allowed if ineligible for or refused regimens with known curative potential (high-dose chemotherapy plus bone marrow transplantation) (if available)
  • Second or third progression and/or recurrence of NHL
  • Second or third relapse/refractory CD20-positive Hodgkin's lymphoma
  • CD20-positive, post-transplantation lymphoproliferative lymphoma that is medically refractory (decreased immunosuppression) to rituximab and/or chemotherapy
Show all 54Show fewer
  • Medically refractory, HIV-associated, CD20-positive NHL
  • Recurrent/refractory CD20-positive lymphoblastic lymphoma
  • Autologous peripheral blood stem cells (PBSC) collected, selected for a minimum of 2 x 10^6 CD34-positive cells per kg, and cryopreserved before study entry
  • Meets one of the following criteria for bone marrow reserve:
  • Good marrow reserve, defined by both of the following:
  • No prior myeloablative stem cell transplantation (SCT)
  • No prior extensive radiotherapy, defined by any of the following:
  • Prior total body irradiation
  • Prior radiotherapy dose of 3,600 cGy or more to cranio-spinal axis
  • Prior radiotherapy to 50% or more of bone marrow
  • Poor marrow reserve, defined by either or both of the following:
  • Prior myeloablative SCT
  • Prior extensive radiotherapy
  • Performance status - Lansky 50-100% (age 10 and under)
  • Performance status - Karnofsky 50-100% (age 11 to 21)
  • At least 2 months
  • Absolute neutrophil count ≥ 1,000/mm^3
  • Platelet count ≥ 100,000/mm^3 for patients with poor marrow reserve (transfusion independent)
  • Platelet count ≥ 150,000 for patients with good marrow reserve (transfusion independent)
  • Hemoglobin ≥ 8.0 g/dL (transfusion allowed)
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • ALT ≤ 5 times ULN
  • Albumin ≥ 2 g/dL
  • Creatinine normal
  • Creatinine clearance or glomerular filtration rate ≥ 70 mL/min
  • Shortening fraction ≥ 27% by echocardiogram
  • Ejection fraction ≥ 50% by MUGA
  • No dyspnea at rest
  • No exercise intolerance
  • Oxygen saturation (SpO_2) > 94% by pulse oximetry (if there is a clinical indication for SpO_2 assessment)
  • Not pregnant or nursing
  • Negative pregnancy test
  • No documented infection that is unresponsive to appropriate antibiotic, antiviral, or antifungal therapy
  • No grade 2 or greater CNS toxicity
  • Seizure disorder allowed if well controlled and on anticonvulsants
  • See Disease Characteristics
  • Recovered from prior immunotherapy
  • At least 1 week since prior antineoplastic biologic agents
  • Prior SCT allowed if the following criteria are met:
  • At least 60 days since prior SCT
  • Full hematopoietic reconstitution post-SCT
  • No evidence of active acute or chronic graft-versus-host disease if post- allogeneic SCT
  • No concurrent sargramostim (GM-CSF)
  • See Disease Characteristics
  • At least 3 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosourea) and recovered
  • See Disease Characteristics
  • Recovered from prior radiotherapy
  • No concurrent medications that would interact with the study drug

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Children's Oncology Group

    Arcadia, California, 91006-3776

Other trials in United States

About this study

Official title: A Phase I Study Of Yttrium-Ibritumomab Tiuxetan (90Y Zevalin, Yttrium (90)-Anti-CD20, NSC # 710085) Preceded By Rituximab In Children With Recurrent/Refractory CD20 Positive Lymphoma

Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy with or without peripheral stem cell transplantation in treating patients who have recurrent or refractory lymphoma. Radiolabeled monoclonal antibodies can locate cancer cells and deliver radioactive tumor-killing substances to them without harming normal cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by anticancer therapy

Read the detailed description

OBJECTIVES:

  1. Determine the maximum tolerated dose (MTD) of yttrium Y 90 ibritumomab tiuxetan (IDEC-Y2B8) when preceded by rituximab in children with recurrent or refractory CD20-positive lymphoma for which no autologous peripheral blood stem cell transplantation (AuPBSCT) is planned. (Group A) If the dose-limiting toxicity (DLT) in group A is purely hematological, determine the MTD of IDEC-Y2B8 when combined with rituximab, AuPBSCT, and filgrastim (G-CSF) in a second group of children with recurrent or refractory CD20-positive lymphoma. (Group B) II. Determine the DLT of rituximab and IDEC-Y2B8 in these patients. III. Determine the dosimetry of indium In 111 ibritumomab tiuxetan preceded by rituximab in these patients.

IV. Determine, preliminarily, the antitumor activity of rituximab and IDEC-Y2B8 in these patients.

  1. Assess the immune cell depletion (B-cell and T-cell) and recovery in patients treated with this regimen.

VI. Determine the human anti-mouse antibody response in patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of yttrium Y 90 ibritumomab tiuxetan (IDEC-Y2B8). Patients are assigned to 1 of 2 groups.

GROUP A (no planned peripheral blood stem cell [PBSC] support): Patients receive rituximab IV over 4-6 hours followed by indium In 111 ibritumomab tiuxetan (IDEC-In2B8) IV over 10 minutes on day 0 and undergo whole body imaging. Patients may then receive rituximab IV over 4-6 hours followed by IDEC-Y2B8 IV over 10 minutes on day 7.

Cohorts of 3-6 patients in each subgroup (A1, A2, and A3) receive escalating doses of IDEC-Y2B8 until the maximum tolerated dose (MTD) is determined (subgroup A1 closed as of 10/8/04). The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity (DLT).

Some patients receive autologous PBSC IV over 30-60 minutes on day 35.

GROUP B (planned PBSC support): Patients receive rituximab, IDEC-In2B8, and IDEC-Y2B8 as in group A. Patients also receive autologous PBSC IV over 30-60 minutes on day 21 and filgrastim (G-CSF) subcutaneously beginning on day 22 and continuing until blood counts recover or day 35.

If the DLT in group A is purely hematological, cohorts of 3-6 patients in group B receive escalating doses of IDEC-Y2B8 until the MTD is determined. The MTD is defined as in group A.

Patients in both groups are followed at days 63, 90, 180, 365, and then annually thereafter.

Being tested
rituximab, indium In 111 ibritumomab tiuxetan, yttrium Y 90 ibritumomab tiuxetan, peripheral blood stem cell transplantation, filgrastim
Medical subject headings
Dendritic Cell Sarcoma, Interdigitating, Burkitt Lymphoma, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rituximabBiological

    Also called IDEC-C2B8, IDEC-C2B8 monoclonal antibody, Mabthera, MOAB IDEC-C2B8

    Given IV

  • indium In 111 ibritumomab tiuxetanRadiation

    Also called IDEC-In2B8

    Given IV

  • yttrium Y 90 ibritumomab tiuxetanRadiation

    Also called 90Y ibritumomab tiuxetan, IDEC Y2B8, Y90 Zevalin, Y90-labeled ibritumomab tiuxetan

    Given IV

  • peripheral blood stem cell transplantationProcedure or surgery

    Also called PBPC transplantation, PBSC transplantation, peripheral blood progenitor cell transplantation, transplantation, peripheral blood stem cell

    Undergo PBSC transplantation

  • filgrastimBiological

    Also called G-CSF, Neupogen

    Given subcutaneously

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00036855
Study groupRoleWhat they receive
Group A (no planned PBSC support)ExperimentalPatients receive rituximab IV over 4-6 hours followed by IDEC-In2B8 IV over 10 minutes on day 0 and undergo whole body imaging. Patients may then receive rituximab IV over 4-6 hours followed by IDEC-Y2B8 IV over 10 minutes on day 7. Some patients receive autologous PBSC IV over 30-60 minutes on day 35.
Receives: Biological: rituximab; Radiation: indium In 111 ibritumomab tiuxetan; Radiation: yttrium Y 90 ibritumomab tiuxetan; Procedure: peripheral blood stem cell transplantation; Other: laboratory biomarker analysis
Group B (planned PBSC support)ExperimentalPatients receive rituximab, IDEC-In2B8, and IDEC-Y2B8 as in group A. Patients also receive autologous PBSC IV over 30-60 minutes on day 21 and G-CSF subcutaneously beginning on day 22 and continuing until blood counts recover or day 35.
Receives: Biological: rituximab; Radiation: indium In 111 ibritumomab tiuxetan; Radiation: yttrium Y 90 ibritumomab tiuxetan; Procedure: peripheral blood stem cell transplantation; Biological: filgrastim; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MTD, defined as that dose at which fewer than one-third of patients experience DLT graded according to the NCI CTC v 2.0

    Measured: Up to day 49

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startJun 2002
  3. Primary completionMar 2005

Why it stopped: Administratively complete.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00036855
Sponsor's protocol ID
NCI-2012-01871
Other IDs
ADVL0013, U01CA097452, CDR0000069331
Status last verified
Jan 2013
First submitted
13 May 2002
Last updated
17 Jan 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing rituximab, indium In 111 ibritumomab tiuxetan and yttrium Y 90 ibritumomab tiuxetan in people with AIDS-related Peripheral/Systemic Lymphoma and AIDS-related Primary CNS Lymphoma, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 54 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Administratively complete.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MTD, defined as that dose at which fewer than one-third of patients experience DLT graded according to the NCI CTC v 2.0 (time frame: Up to day 49). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00036855.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2013.

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