MDACC Study Summary 2005-0046

Study Summary
No. 2005-0046:.......Lymphoma......Luis E. Fayad......Lymphoma/Myeloma

Study Summary Title



Study Summary Number:	2005-0046

Study Title:	A Phase I Study of Immunotherapy with hA20 Administered Once Weekly for 4 Consecutive Weeks in Patients with CD20+ Non-Hodgkin's Lymphoma

Physician

New Patient Referral



Name:	Luis E. Fayad	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:	Over 22 days with post-treatment evaluations over 12 wks. Evaluations continue in pts with stable or objective responses every 3 months until PD or 2 years. Otherwise F/U is only required until resolution of any treatment related abnormalities.

Treatment Agents:	hA20	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 dose of the antibody hA20 that can be safely given to patients with CD20+ B-cell NHL. Researchers will look at how the study drug affects the body and behaves in the blood circulation, as well as how effective the drug is in treating NHL.

Study Objectives / Outcomes

The goal of this study is to provide supporting data to determine feasible doses for further immunotherapy studies.

The primary objective is to document the safety, tolerance and lack of immunogenicity of hA20at these dosing levels and with this consecutive weekly administration schedule. Safety and tolerance will be evaluated by toxicities or adverse events encountered during or after hA20 administration, changes in vital signs, physical examination, or laboratories including hematology, T-cell levels, serum immunoglobulins, serum chemistries, and urinalysis. Immunogenicity will be evaluated from serum samples collected before and following hA20 administration, for analysis of human anti-hA20 antibodies (HAHA) by Sponsor.

The secondary objectives are to obtain preliminary evidence of efficacy and to assess pharmacodynamics and pharmacokinetics. Objective evidence of therapeutic efficacy will be obtained from changes in lesions on baseline and post-treatment CT scans, using Cheson criteria to classify tumor responses, duration of responses and time to disease progression. Pharmacokinetics (PK) will be evaluated from serum samples collected during and following hA20 administration, for analysis of hA20 levels by Sponsor. Pharmacodynamics (PD) will be evaluated from changes in circulating B-cells following hA20 administration.

Study Status Information



Study Activation / Registration Date:	02/02/2006

IRB Review and Approval Date:	03/28/2005

Study Type:	Phase I

Recruitment Status:	Closed

Projected Accrual:	Up to 98

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 >/= 18 years old.

2) Histological diagnosis of CD20+ B-cell NHL (all grades) by WHO lymphoma criteria.

3) Failed at least one prior standard chemotherapy regimen or rituximab treatment for NHL.

4) Measureable NHL disease by CT, with at least one lesion >/= 1.5 cm in one dimension.

5) Adequate performance status (>/= 70 Karnofsky scale, 0-1 ECOG) with an estimated life expectancy of at least 6 months.

6) Adequate hematologic status, without ongoing transfusional support (hemoglobin >/= 10g/dL, ANC >/= 1.5 x 10^9/L, platelets >/= 100 x 10^9/L)

7) Adequate renal and hepatic function, defined as: Creatinine </= 1.5 x Institution Upper Limit of Normal (IULN), bilirubin </= 1.5 x IULN, AST and ALT </= 2.5 x IULN

8) Otherwise < Grade 1 toxicity at study entry by NCI CTC version 3.0, including recovery from all acute toxicities incurred as a result of previous surgery, radiotherapy or chemotherapy, whether investigational or conventional.

9) At least 12 months beyond previous rituximab treatment, 12 weeks beyond autologous stem cell transplant, 4 weeks beyond chemotherapy, other experimental treatments, or any radiation therapy to the index lesion(s).

10) Ability to provide signed, informed consent.

Exclusion Criteria:

1) Pregnant or lactating women. Women of childbearing potential are required to have a negative pregnancy test.

2) Women of childbearing potential and fertile men who are not practicing or who are unwilling to practice birth control while enrolled in the sudy until at least 12 weeks after the last weekly hA20 infusion.

3) Rituximab resistant, defined as having progressed during or within 6 months of rituximab treatment.

4) Excessive toxicity to rituximab (NCI CTC Grade 3 or 4) or known to be HACA positive.

5) Prior radioimmunotherapy, including Zevalin or Bexxar.

6) Prior therapy with other human or humanized monoclonal antibodies, unless HAHA tested and negative.

7) Primary CNS lymphoma, HIV lymphoma or transformed lymphoma, or presence of symptomatic CNS metastases or carcinomatous meningitis.

8) Bulky disease by CT, defined as any single mass > 10 cm in its greatest diameter.

9) Pleural effusion with positive cytology for lymphoma.

10) Patients known to be HIV positive, hepatitis B positive, or hepatitis C positive.

11) Known autoimmune disease or presence of autoimmune phenomena.

12) Evidence of infection or requiring antibiotics within 5 days.

13) Corticosteroid use within 2 weeks.

14) Prior malignancy with less than a 5-year disease-free interval, excluding non-melanoma skin cancers and carcinoma in situ of the cervix.

15) Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.

Links

Registration Number: NCT00285428
Study Information on Clinical Trials Registry (clinicaltrials.gov)