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LymphomaPhase 1NCT00243087

Investigation of Safety, Tolerability and Maximum Tolerated Dose (MTD) of BI 2536 in Patients With Recurrent Advanced Aggressive Non-Hodgkin's Lymphoma (NHL)

A Phase 1 study testing BI 2536 in people with Lymphoma, run by Boehringer Ingelheim at 4 sites in United States.

Completed

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

Official record
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Trial summary

RATIONALE: BI 2536 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying the side effects and best dose of BI 2536 in treating patients with refractory or relapsed advanced non-Hodgkin's lymphoma. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Lymphoma
What is being tested?
BI 2536
How many people
41 participants
Where
4 sitesUnited States
Study dates
Jul 2005to Aug 2008
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 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed advanced aggressive non-Hodgkin's lymphoma (NHL), including any of the following subtypes:
  • B-cell NHL, including any of the following subtypes:
  • Diffuse large B-cell lymphoma
  • Primary mediastinal (thymic) B-cell lymphoma
  • Intravascular large B-cell lymphoma
  • Immunoblastic B-cell lymphoma
  • Mantle cell lymphoma
  • Burkitt's lymphoma
  • Follicular grade 3b lymphoma
  • T-cell NHL, including any of the following subtypes:
  • Anaplastic large cell lymphoma
  • Peripheral T-cell lymphoma, not otherwise specified
  • De novo or transformed disease
  • Refractory (i.e., disease not amenable to standard therapy) or relapsed disease, as evidenced by 1 of the following:
  • Refractory to OR relapsed after ≥ 1 prior combination chemotherapy regimen
  • Refractory to OR relapsed after prior CD20-based immunotherapy (for patients eligible to receive such therapy)
  • Refractory after prior high-dose chemotherapy and autologous stem cell transplantation AND ≥ 100 days post transplantation
  • At least 1 bidimensionally measurable lesion ≥ 1.5 cm by CT scan, MRI, x-ray, or clinical examination
  • No active CNS lymphoma

PATIENT CHARACTERISTICS:

Performance status

  • ECOG 0-2

Life expectancy

  • At least 3 months

Hematopoietic

  • Absolute neutrophil count ≥ 1,000/mm^3
  • Platelet count ≥ 75,000/mm^3
  • Hemoglobin ≥ 9 g/dL
  • No known coagulopathy

Hepatic

  • ALT and/or AST ≤ 2.5 times upper limit of normal (ULN) (< 5 times ULN if due to hepatic lymphoma)
  • Bilirubin ≤ 1.5 times ULN

Renal

  • Creatinine ≤ 2.0 mg/dL

Immunologic

  • No known HIV infection
  • No serious active infection that requires IV antibiotics or antifungal or antiviral agents

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective double-method contraception during and for 1 year after completion of study treatment
  • No known or suspected alcohol or drug abuse
  • No sensory or motor neuropathy ≥ grade 3
  • No other malignancy within the past 5 years except nonmelanoma skin cancer
  • No other life-threatening illness or organ dysfunction that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics
  • See Radiotherapy
  • More than 3 weeks since prior and no concurrent immunotherapy
  • No prior allogeneic bone marrow transplantation

Chemotherapy

  • See Disease Characteristics
  • More than 3 weeks since prior and no concurrent chemotherapy (6 weeks for nitrosoureas or mitomycin)

Endocrine therapy

  • No concurrent hormonal therapy

Radiotherapy

  • No prior radiotherapy to the only site of measurable disease unless there is documented disease progression after completion of radiotherapy
  • More than 8 weeks since prior and no concurrent systemic radioimmunotherapy
  • More than 3 weeks since prior and no concurrent radiotherapy
  • Concurrent palliative radiotherapy to sites other than the only measurable target lesion allowed for symptom control provided the reason for radiotherapy does not reflect progressive disease

Other

  • No concurrent warfarin for therapeutic anticoagulation

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • M. D. Anderson Cancer Center at University of Texas

    Houston, Texas, 77030-4009

  • UNMC Eppley Cancer Center at the University of Nebraska Medical Center

    Omaha, Nebraska, 68198-6805

  • James P. Wilmot Cancer Center at University of Rochester Medical Center

    Rochester, New York, 14642

  • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

Official title: An Open Phase I Single Dose Escalation Study of BI 2536 Administered Intravenously in Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma

RATIONALE: BI 2536 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase I trial is studying the side effects and best dose of BI 2536 in treating patients with refractory or relapsed advanced non-Hodgkin's lymphoma.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose of BI 2536 in patients with refractory or relapsed advanced aggressive non-Hodgkin's lymphoma.
  • Determine the safety and tolerability of this drug in these patients.

Secondary

  • Determine the pharmacokinetic profile of this drug in these patients.
  • Determine, preliminarily, the antitumor activity of this drug in these patients.

OUTLINE: This is a dose-escalation, open-label, uncontrolled, multicenter study.

Patients receive BI 2536 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of BI 2536 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 toxicity during the first treatment course. Up to 24 patients are treated at the MTD.

After completion of study treatment, patients are followed periodically until disease progression or initiation of another cancer treatment.

PROJECTED ACCRUAL: A maximum of 50 patients will be accrued for this study.

Conditions
Lymphoma
Being tested
BI 2536
Keywords
stage IV adult diffuse large cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult Burkitt lymphoma, stage IV adult Burkitt lymphoma, stage IV grade 3 follicular lymphoma, recurrent grade 3 follicular lymphoma, stage IV mantle cell lymphoma, recurrent mantle cell lymphoma, recurrent adult immunoblastic large cell lymphoma, stage IV adult immunoblastic large cell lymphoma, anaplastic large cell lymphoma, recurrent adult T-cell leukemia/lymphoma, stage IV adult T-cell leukemia/lymphoma, stage III adult Burkitt lymphoma, stage III adult diffuse large cell lymphoma, stage III adult immunoblastic large cell lymphoma, stage III adult T-cell leukemia/lymphoma, stage III grade 3 follicular lymphoma, stage III mantle cell lymphoma
Medical subject headings
Lymphoma, Lymphoma, Large B-Cell, Diffuse, Burkitt Lymphoma, Lymphoma, Follicular, Lymphoma, Mantle-Cell, Lymphoma, Large-Cell, Immunoblastic, Lymphoma, Large-Cell, Anaplastic, 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.

  • BI 2536Drug

What is being measured

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

  1. Maximum tolerated dose as measured by CTCAE v3.0 at days 1-22 of each course

    Measured: up to 22 days of each course

  2. Dose-limiting toxicity as measured by CTCAE v3.0 at days 1-22 of each course

    Measured: up to 22 days of each course

Secondary outcomes (2)

  1. Objective tumor response by CT scan or MRI as measured by RECIST criteria on day 22 of each even numbered course

    Measured: day 22 of every second course

  2. Pharmacokinetics as measured in blood samples at days 1, 2, 3, and 8 during first course and on day 1 of each subsequent course

    Measured: day 22 of each course

Timeline

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

  1. First posted21 Oct 2005 (estimated)
  2. Study startJul 2005
  3. Primary completionAug 2008

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
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00243087
Sponsor's protocol ID
CDR0000446176
Other IDs
BOEH-BI-1216.3, UNMC-16005
Status last verified
Dec 2024
First submitted
20 Oct 2005
Last updated
20 Dec 2024
Results posted
No
Individual data sharing
Yes: Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BI 2536 in people with Lymphoma, run by Boehringer Ingelheim at 4 sites 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 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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 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.

What does the primary outcome measure?

Maximum tolerated dose as measured by CTCAE v3.0 at days 1-22 of each course (time frame: up to 22 days of each course). The study lists 2 primary outcomes in all. 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 NCT00243087.

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 Dec 2024.

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