Know Cancer

or
forgot password

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


Phase 1
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Safety Issue:

Yes

Principal Investigator

Julie M. Vose, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Nebraska

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000446176

NCT ID:

NCT00243087

Start Date:

July 2005

Completion Date:

Related Keywords:

  • Lymphoma
  • 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
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large-Cell, Immunoblastic

Name

Location

James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester, New York  14642
UNMC Eppley Cancer Center at the University of Nebraska Medical Center Omaha, Nebraska  68198-7680
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center Washington, District of Columbia  20007
M. D. Anderson Cancer Center at University of Texas Houston, Texas  77030-4009