AzTrials
AzTrials

LymphomaPhase 1/2NCT00019227

Monoclonal Antibody Therapy in Treating Patients With Leukemia

A Phase 1/2 study testing pentetic acid calcium and yttrium Y 90 daclizumab in people with Lymphoma and Radiation Toxicity, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I/II trial to study the effectiveness of radiolabeled monoclonal antibody plus pentetic acid calcium in patients with leukemia. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma, Radiation Toxicity
What is being tested?
pentetic acid calcium and yttrium Y 90 daclizumab
Type of treatment
Surgery or procedure
How many people
Not given
Where
1 siteUnited States
Study dates
Oct 1996to Jul 2006
Phase
Phase 1/2
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed adult T-cell leukemia or lymphoma (ATL) of any stage
  • Tac expression of malignant cells confirmed by one of the following:
  • At least 10% of peripheral blood, lymph node, or dermal malignant cells reactive with anti-Tac by immunofluorescent staining
  • Soluble interleukin-2 receptor levels greater than 1,000 U/mL (normal geometric mean = 235; 95% confidence intervals = 112-502 U/mL)
  • Measurable disease required
  • More than 10% (i.e., strongly Tac-expressing) abnormal cells in peripheral blood considered measurable disease
  • All stages of Tac-expressing adult T-cell leukemia are eligible
  • Smoldering ATL patients are eligible only if the symptoms and sites of involvement by ATL are such that there is a medical indication to treat
  • Smoldering ATL, defined as:
  • Lymphocyte count less than 4,000/mm^3
  • Less than 5% abnormal lymphocytes on morphologic exam of peripheral blood
  • No hypercalcemia
  • Lactate dehydrogenase no greater than 1.5 times normal
  • No lymphadenopathy
  • No involvement of extranodal organs except skin or lung
  • No malignant pleural effusion or ascites
  • No symptomatic CNS disease due to ATL
  • Concurrent diagnosis of tropical spastic paraparesis allowed
  • No detectable levels (i.e., greater than 250 ng/mL) of antibody to study drug as assessed by ELISA

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Not specified

Life expectancy:

  • Greater than 2 months

Hematopoietic:

  • Absolute granulocyte count at least 1,000/mm^3
  • Platelet count at least 75,000/mm^3

Hepatic:

  • Bilirubin less than 2.0 mg/dL (unless directly due to ATL)
  • AST/ALT less than 2.5 times normal

Renal:

  • Creatinine less than 1.5 mg/dL OR
  • Creatinine clearance greater than 35 mL/min

Cardiovascular:

  • No clinical cardiac failure

Pulmonary:

  • No symptomatic pulmonary dysfunction unless due to underlying malignancy

Other:

  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • At least 4 weeks since prior cytotoxic chemotherapy

Endocrine therapy

  • Concurrent corticosteroids allowed

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • Not specified

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

    Bethesda, Maryland, 20892-1182

Other trials in United States

About this study

Official title: PHASE I/II STUDY OF TAC-EXPRESSING ADULT T-CELL LEUKEMIA (ATL) WITH YTTRIUM-90 (90Y)-RADIOLABELED HUMANIZED ANTI-TAC AND CALCIUM-DTPA

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase I/II trial to study the effectiveness of radiolabeled monoclonal antibody plus pentetic acid calcium in patients with leukemia.

Read the detailed description

OBJECTIVES:

  • Determine the maximum tolerated dose of yttrium Y 90 daclizumab (90Y daclizumab) when combined with pentetic acid calcium in adults with Tac-expressing T-cell leukemia.
  • Determine the therapeutic efficacy and toxicity of this regimen in these patients.
  • Monitor patients treated on this regimen for circulating infused antibody (free and labeled) and for the serum concentration of soluble interleukin-2 receptor.
  • Evaluate, in a preliminary manner, the immunogenicity of daclizumab.
  • Determine the effect of 90Y daclizumab on various components of the circulating cellular immune system.
  • Determine whether there is additional urinary excretion of yttrium Y 90 when compared to that observed previously in patients treated without pentetic acid calcium.

OUTLINE: This is a dose escalation study of yttrium Y 90 daclizumab (90Y daclizumab).

Patients receive 90Y daclizumab IV over 2 hours on day 1 and a fixed dose of pentetic acid calcium IV over 5 hours for 3 days. Treatment repeats every 6 weeks for a maximum of 9 courses in the absence of disease progression or circulating antibodies to humanized anti-Tac.

Cohorts of 3-6 patients receive escalating doses of 90Y daclizumab until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities. Additional patients are treated at the MTD.

Patients are followed at 4-6 weeks.

PROJECTED ACCRUAL: Up to 15 patients will be accrued for the phase I portion of the study. A total of 30 patients will be accrued for the phase II portion of the study.

Being tested
pentetic acid calcium, yttrium Y 90 daclizumab
Keywords
stage I adult T-cell leukemia/lymphoma, stage II adult T-cell leukemia/lymphoma, stage III adult T-cell leukemia/lymphoma, stage IV adult T-cell leukemia/lymphoma, recurrent adult T-cell leukemia/lymphoma, radiation toxicity
Medical subject headings
Lymphoma, Radiation Injuries, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

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

  • pentetic acid calciumDrug

  • yttrium Y 90 daclizumabRadiation

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 startOct 1996
  3. Study completionJul 2006

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 1/2
Primary purpose
Treatment
IDs, dates and publications
ClinicalTrials.gov ID
NCT00019227
Sponsor's protocol ID
CDR0000065240
Other IDs
NCI-96-C-0147K
Status last verified
Mar 2003
First submitted
11 Jul 2001
Last updated
20 Jun 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing pentetic acid calcium and yttrium Y 90 daclizumab in people with Lymphoma and Radiation Toxicity, 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?

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: finished, as of the sponsor's last update on 20 Jun 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00019227.

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 20 Jun 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in