Protocol Number: 07-C-0108

Title:

A Phase 1, Multicenter, Dose Escalation Study of CAT-8015 in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL), Prolymphocytic Leukemia (PLL), or Small Lymphocytic Lymphoma (SLL)

Number:

07-C-0108

Summary:

Background:

-CAT-8015 is a substance called a recombinant immunotoxin that is made by genetic engineering. Each CAT-8015 molecule is made up of two parts: 1) a mouse antibody (type of protein the body makes in response to a foreign substance) that binds to a protein called CD22, which is found on the surface of certain cancer cells; and 2) a toxin (type of poison) that is produced by bacteria.

-In laboratory experiments, CAT-8015 has killed leukemia cells with the CD22 protein on their surface and has reduced tumors in mice.

Objectives:

-Find out if CAT-8015 is safe and tolerable.

-Learn how CAT-8015 is broken down in the human body.

-Learn the dose of CAT-8015 that does not cause unacceptable side effects.

Eligibility:

-Patients 18 years of age or older with CLL, PLL or SLL whose disease does not improve with standard therapy and who have cancer cells with the CD22 protein on their surface.

Design:

-Small groups of 3 to 6 patients take CAT-8015 at a certain dose level. If these patients do not experience significant side effects, subsequent groups of patients take the drug at increasing dose levels until the maximum tolerated dose (MTD) is reached. Once this dose is determined, 15 to 25 new patients are added to the MTD group, depending on how well CAT-8015 is tolerated.

-CAT-8015 is given in 4-week treatment cycles. It is given by intravenous (into a vein) infusion every other day for 3 doses (days 1, 3, 5).

-Patients have regularly scheduled visits for physical examinations, blood and urine tests, CT scans and, possibly, bone marrow biopsies.

-Patients may receive up to 24 months of follow-up evaluation after the last treatment cycle.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Clinical hold/Recruitment or enrollment suspended

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Currently Not Provided

Keyword(s):

Monoclonal Antibody

Recombinant Immunotoxin

Pseudomonas Exotoxin

Targeted Therapy

Biologic Therapy

Recruitment Keyword(s):

Leukemia

Chronic Lymphocytic Leukemia

CLL

Small Lymphocytic Lymphoma

SLL

Prolymphocytic Leukemia

PLL

Condition(s):

Chronic Lymphocytic Leukemia (CLL)

Prolymphocytic Leukemia (PLL)

Small Lymphocytic Leukemia (SLL)

Investigational Drug(s):

CAT 8015 (HA22)

Investigational Device(s):

None

Interventions:

Drug: CAT 8015 (HA22)

Supporting Site:

National Cancer Institute

Contact(s):

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):

Cheson BD, Bennett JM, Grever M, Kay N, Keating MJ, O'Brien S, Rai KR. National Cancer Institute-sponsored Working Group guidelines for chronic lymphocytic leukemia: revised guidelines for diagnosis and treatment. Blood. 1996 Jun 15;87(12):4990-7.

Chiorazzi N, Rai KR, Ferrarini M. Chronic lymphocytic leukemia. N Engl J Med. 2005 Feb 24;352(8):804-15. Review. No abstract available.

Faguet GB. Chronic lymphocytic leukemia: an updated review. J Clin Oncol. 1994 Sep;12(9):1974-90. Review.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department Clinical Research Informatics, CC.

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