MDACC Study Summary ID02-148 (Archived)

Study Summary
No. ID02-148:.......Lymphoma......Barbara Pro......Lymphoma/Myeloma

Study Summary Title



Study Summary Number:	ID02-148

Study Title:	A Phase II Study of G3139 (Bcl-2 Antisense) And Rituximab in Patients with Recurrent B-cell Non-Hodgkin's Lymphomas

Physician

New Patient Referral



Name:	Barbara Pro	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 II	Return Visit:	Weekly during treatment, and every 3 months thereafter

Treatment Agents:	G3139 Rituximab	Home Care:	None

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	None


Description/ Intervention:	The goal of this clinical research study is to learn if the combination of G3139 and Rituximab can help to shrink or slow the growth of the tumor in patients with B-cell non-Hodgkin's lymphoma who have not responded to earlier treatment. G3139 is an investigational drug. The safety of this combination treatment will also be studied.

Study Objectives / Outcomes

Primary:
To evaluate the therapeutic efficacy and toxicity of G3139 plus Rituximab in patients with recurrent B-cell Non-Hodgkin's lymphoma (NHL).

Secondary:
To determine the effect of G3139 and Rituximab on Bcl-2 expression

Study Status Information



Study Activation / Registration Date:	01/07/2003

IRB Review and Approval Date:	04/03/2002

Study Type:	Therapeutic

Recruitment Status:	Terminated

Projected Accrual:	120

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) Must have recurrent B-cell NHL and measurable disease.

2) Age greater than or equal to 18 years of age.

3) No anti-lymphoma therapy within the past 4 weeks.

4) Must have a good performance status (less than or equal to 2 Zubrod, greater than or equal to 60 Karnofsky).

5) Must have a good marrow reserve: ANC greater than or equal to 1,000, platelets greater than or equal to 75,000, hemoglobin greater than or equal to 10g/dL.

6) Bilirubin less than or equal to 1.5 mg/dL, SGOT, SGPT less than or equal to 2 times upper limit of laboratory normals; alkaline phosphatase less than or equal to 2 times upper limit of laboratory normals.

7) Serum creatinine less than or equal to 1.8 mg/dL.

8) Must sign a consent form, and must have a life expectancy of greater than 12 weeks.

9) No more than 3 prior chemotherapy regimens.

10) Patients who are either Rituximab naive, have previously responded to Rituximab, or are refractory to Rituximab used alone or in combination with chemotherapy.

Exclusion Criteria:

1) HIV positive.

2) Active infection or history of opportunistic infections.

3) Pregnant women and women of childbearing age who are not practicing adequate contraception. Men who are not willing to use an effective method of contraception.

4) History of second cancer (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or other cancer for which the patient has been disease-free for 5 or more years).

5) Active autoimmune disease.

6) Other significant medical diseases (defined in protocol).

7) Patients with CLL.

8) Prior exposure to G3139.

Links

Registration Number: NCT00054639
Study Information on Clinical Trials Registry (clinicaltrials.gov)