MDACC Study Summary 2004-0133 (Archived)

Study Summary
No. 2004-0133:.......Lymphoma......Jorge Romaguera......Lymphoma/Myeloma

Study Summary Title



Study Summary Number:	2004-0133

Study Title:	A Phase I Study of CMC-544 Administered as single agent in subjects with B-cell Non-Hodgkin's Lymphoma

Physician

New Patient Referral



Name:	Jorge Romaguera	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:	Weekly for clinic visit during first two weeks, then close to a month later.

Treatment Agents:	CMC-544	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 safe dose of the drug CMC-544 that can be given to treat B-cell NHL. The effectiveness of this drug will be studied. The amount of CMC-544 in the blood will also be studied to help researchers learn how CMC-544 is used, broken down, and is removed from the body.

Study Objectives / Outcomes

Primary: For Part 1:
To determine the maximal tolerated dose (MTD), the tolerability, and the initial safety profile of CMC-544 in subjects with B-cell NHL.
For Part 2: To determine the tolerability and initial safety profile of CMC-544.
Secondary:
To evaluate the PK, and pharmakodinamics of CMC-544
To obtain preliminary information on the antitumor activity of CMC-544 administered as single agent to subjects with B-cell NHL.
To obtain progression free survival and overall survival in the expanded cohort.

Study Status Information



Study Activation / Registration Date:	08/30/2005

IRB Review and Approval Date:	03/17/2004

Study Type:	Cancer Control

Recruitment Status:	Terminated

Projected Accrual:	37-78

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) Patients with diagnosis of CD22-positive, B-cell non-Hodgkin's lymphoma, who progressed after at least two previous treatments. The histologies acceptable are small lymphocytic lymphoma, lymphoplasmacytic lymphoma, splenic marginal zone B-cell lymphoma, nodal marginal cell lymphoma, MALT lymphoma, follicular lymphoma, mantle cell lymphoma, diffuse large B-cell lymphoma, mediastinal large B-cell lymphoma. SLL will be included if the peripheral blood lymphoma cells are less than 5.0 x 10^9/L.

2) Age 18 years or older

3) ECOG performance status </= 2

4) Life expectancy >/= 12 weeks

5) Absolute neutrophil count >/= 1,500/microL, platelets >/= 100,000/microL or >/= 75,000/microL if due to bone marrow disease burden based on the judgement of the investigator.

6) Serum Creatinine, Total Bilirubin </= 1.5 x ULN, AST/SGOT and ALT/SGPT </= 2.5 x ULN

7) At least 1 measurable disease lesion at inclusion in area of no prior radiation therapy, or clear progression in an area previously irradiated. The lesion has to be at least 1.5 cm in one of the diameter by CT or MRI at inclusion.

8) Negative pregnancy test within a week.

9) Signed informed consent.

10) At the MTD part 2 of the study, patients must have one of the followings: a) Follicular lymphoma previously treated with at least one dose of rituximab, but have not received radioimmunotherapy; b) Diffuse large B-cell lymphoma

Exclusion Criteria:

1) Candidates for potentially curative therapies in the opinion of the investigator

2) Chronic lymphocytic leukemia

3) Burkitt's lymphoma, primary effusion lymphoma, and precursor lymphoblastic lymphoma

4) Prior allogeneic hematopoietic stem cell transplant

5) Prior treatment with anti-CD22 antibodies

6) Major surgery, not related to debulking surgical procedures within 3 weeks before screening.

7) Chemotherapy, cancer immmunosuppressive therapy, growth factors other than erythropoietin within 4 weeks before first dose.

8) Prior chemotherapy with nitrosoureas or mitomycin C within 6 weeks.

9) Female patients pregnant or breastfeeding

10) CNS disease

11) Known seropositivity for HIV, or chronic hepatitis B or C infection.

12) Active secondary malignancy other than non-melanoma skin cancer. Patients with previous cancer must be free of a secondary malignancy for 5 years.

Links

Registration Number: NCT00081887
Study Information on Clinical Trials Registry (clinicaltrials.gov)