MDACC Study Summary 2005-0433

Study Summary
No. 2005-0433:.......Lymphoma......Anas Younes......Lymphoma/Myeloma

Study Summary Title



Study Summary Number:	2005-0433

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

Physician

New Patient Referral



Name:	Anas Younes	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Lymphoma/Myeloma	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-2860 Contact us about clinical trials

General Information



Disease Group:	Lymphoma	Supported By:	N/A

Phase of Study:	Phase I	Return Visit:	During each course, patient will return Day 1, 2, 3, 8, 15, and 22. After treatment is completed, patient will return every six weeks for the first 3 months and then every three months, thereafter.

Treatment Agents:	BI 2536	Home Care:	N/A

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this clinical research study is to find the highest tolerable dose of BI 2536 BS that can be given to people with Non-Hodgkin's lymphoma. Another goal is to find out what effects, good or bad, BI 2536 BS has on the cancer as well as the way the body processes BI 2536 BS (also called pharmacokinetics or "PK" testing).

Study Objectives / Outcomes

The primary objectives of this trial are to determine the safety, tolerability, and MTD of BI 2536.

The secondary objectives are to characterize the pharmacokinetic profile of BI 2536 and to obtain preliminary information on the antitumor activity of this compound in patients with advanced NHL.

Study Status Information



Study Activation / Registration Date:	11/07/2005

IRB Review and Approval Date:	08/03/2005

Study Type:	Therapeutic

Recruitment Status:	Closed

Projected Accrual:	50

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Male or female patients with histologically or cytologically confirmed aggressive de novo or transformed NHL, as defined by REAL/WHO classification, specifically including B-cell and T-cell non-Hodgkin's lymphoma if the following subtypes are: B-cell neoplasms, diffuse large B-cell lymphoma, immunoblastic B-cell lymphoma, mantle cell lymphoma, Burkitt lymphoma, follicular Grade 3b, and T-cell neoplasms, anaplastic large cell lymphoma, peripheral T-cell lymphoma, not otherwise specified.

2) Patients with recurrent disease or disease that is currently not amenable to standard therapy including those who have: a) Relapsed after or are refractory to at least one or more prior regimens of multiagent chemotherapy; b) Relapsed after or are refractory to CD20-based immunotherapy if eligible, c) Are not eligible for an autologous stem cell transplantation (ASCT), d) Relapsed after prior ASCT and be at least day + 100 post-transplant.

3) At least one bi-dimensionally measurable lesion with clearly defined margins that are >/= to 1.5 cm in the largest dimension determined by one or more techniques (CT, MRI, X-ray, or clinical examination)

4) Age 18 years or older.

5) Life expectancy of at least three (3) months.

6) Eastern Coorperative Oncology Group (ECOG) performance score < / = 2.

7) Written informed consent that is consistent with ICH-GCP guidelines.

Exclusion Criteria:

1) Prior chemo-, radio-, or immunotherapy within the past three (3) weeks before start of therapy or concomitantly with this study.

2) Prior chemotherapy with nitrosoureas or mitomycin C (including generics) within past six (6) weeks before start of therapy or concomitantly with this study.

3) Prior systemic radioimmunotherapy within past eight (8) weeks before start of therapy or concomitantly with this study.

4) Prior allogeneic bone marrow transplantation.

5) Active central nervous system (CNS) lymphoma; a lumbar puncture is not required unless CNS involvement with NHL is clinically suspected.

6) Radiotherapy to an area of measurable disease (unless disease progression had been documented following completion of therapy).

7) Other malignancy diagnosed within the past 5 years (other than non-melanomatous skin cancer).

8) Absolute neutrophil count (ANC) < 1,000/microl, platelet count < 75,000/microl, or hemoglobin < 9 gm/dL.

9) Total bilirubin > 1.5 X ULN, alanine amino transferase (ALT) and/or aspartate amino transferase (AST) > 2.5 X ULN (> / = 5 X ULN if due to hepatic lymphoma).

10) Serum creatinine > 2.0 mg/dL (> 176 micromole/L, SI Unit equivalent).

11) Women and men who are sexually active and unwilling to use a medically acceptable method of contraception.

12) Pregnancy or breast feeding.

13) Known or suspected active alcohol or drug abuse.

14) Patients with known HIV infection.

15) Patients with any serious active infection (i.e., requiring an IV antibiotic, antifungal, or antiviral agent).

16) Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator, would either compromise patient safety or interfere with the evaluation of the safety of the test drug.

17) Patients unable to comply with the protocol.

18) Patients with a known pre-existing coagulopathy or requiring therapeutic anticoagulation with warfarin (Coumadin).

19) Patients with neuropathy (sensory or motor) > / = CTCAE Grade 3.

Links

Registration Number: NCT00243087
Study Information on Clinical Trials Registry (clinicaltrials.gov)